Trial Outcomes & Findings for Regional Versus General Anesthesia for Promoting Independence After Hip Fracture (NCT NCT02507505)

NCT ID: NCT02507505

Last Updated: 2024-05-13

Results Overview

Will be assessed via telephone interview

Recruitment status

COMPLETED

Study phase

Target enrollment

1848 participants

Primary outcome timeframe

Approximately 60 days after Randomization

Results posted on

2024-05-13

Participant Flow

Of the 1848 participants who provided informed consent, 248 withdrew consent prior to randomization; 1600 participants were randomly assigned to a treatment group and continued in the study.

Participant milestones

Participant milestones
Measure	Regional Anesthesia Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Overall Study STARTED	795	805
Overall Study COMPLETED	712	733
Overall Study NOT COMPLETED	83	72

Reasons for withdrawal

Reasons for withdrawal
Measure	Regional Anesthesia Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Overall Study Withdrawal by Subject	13	11
Overall Study Participant unable to be contacted within 60-day interview window	56	44
Overall Study Participant contacted but walking status was unknown	14	16
Overall Study Death before receipt of anesthesia	0	1

Baseline Characteristics

Race was reported by patients or their proxies; number analyzed is the number of participants who provided data for this Baseline Measure.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regional Anesthesia n=795 Participants Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=805 Participants Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.	Total n=1600 Participants Total of all reporting groups
Age, Continuous	77.7 years STANDARD_DEVIATION 10.7 • n=795 Participants	78.4 years STANDARD_DEVIATION 10.6 • n=805 Participants	78.1 years STANDARD_DEVIATION 10.7 • n=1600 Participants
Sex: Female, Male Female	537 Participants n=795 Participants	535 Participants n=805 Participants	1072 Participants n=1600 Participants
Sex: Female, Male Male	258 Participants n=795 Participants	270 Participants n=805 Participants	528 Participants n=1600 Participants
Race/Ethnicity, Customized White	683 Participants n=762 Participants • Race was reported by patients or their proxies; number analyzed is the number of participants who provided data for this Baseline Measure.	691 Participants n=774 Participants • Race was reported by patients or their proxies; number analyzed is the number of participants who provided data for this Baseline Measure.	1374 Participants n=1536 Participants • Race was reported by patients or their proxies; number analyzed is the number of participants who provided data for this Baseline Measure.
Race/Ethnicity, Customized Black	55 Participants n=762 Participants • Race was reported by patients or their proxies; number analyzed is the number of participants who provided data for this Baseline Measure.	67 Participants n=774 Participants • Race was reported by patients or their proxies; number analyzed is the number of participants who provided data for this Baseline Measure.	122 Participants n=1536 Participants • Race was reported by patients or their proxies; number analyzed is the number of participants who provided data for this Baseline Measure.
Race/Ethnicity, Customized Other or more than one race	24 Participants n=762 Participants • Race was reported by patients or their proxies; number analyzed is the number of participants who provided data for this Baseline Measure.	16 Participants n=774 Participants • Race was reported by patients or their proxies; number analyzed is the number of participants who provided data for this Baseline Measure.	40 Participants n=1536 Participants • Race was reported by patients or their proxies; number analyzed is the number of participants who provided data for this Baseline Measure.
Race/Ethnicity, Customized Hispanic ethnic group	15 Participants n=750 Participants • Ethnicity was reported by patients or their proxies. Data missing for some participants.	12 Participants n=763 Participants • Ethnicity was reported by patients or their proxies. Data missing for some participants.	27 Participants n=1513 Participants • Ethnicity was reported by patients or their proxies. Data missing for some participants.
Region of Enrollment Canada	210 participants n=795 Participants	212 participants n=805 Participants	422 participants n=1600 Participants
Region of Enrollment United States	585 participants n=795 Participants	593 participants n=805 Participants	1178 participants n=1600 Participants
3D-CAM Assessment for Delirium	96 Participants n=746 Participants • Only participants with completed baseline 3D-CAM assessments are included.	104 Participants n=753 Participants • Only participants with completed baseline 3D-CAM assessments are included.	200 Participants n=1499 Participants • Only participants with completed baseline 3D-CAM assessments are included.

PRIMARY outcome

Timeframe: Approximately 60 days after Randomization

Will be assessed via telephone interview

Outcome measures

Outcome measures
Measure	Regional Anesthesia n=712 Participants Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=733 Participants Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance	132 Participants	132 Participants

SECONDARY outcome

Timeframe: Approximately 60, 180, and 365 days after randomization

Population: Patients providing data at each time point

Will be assessed via the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The 12-item WHODAS 2.0 scale measures disability in six functional domains (cognition, mobility, self-care, social interaction, life activities, and community participation). Scores range from 0 to 100, with lower scores indicating lower degrees of disability.

Outcome measures

Outcome measures
Measure	Regional Anesthesia n=280 Participants Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=276 Participants Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Overall Health and Disability 180-day outcome	10.4 score on a scale Interval 2.3 to 27.1	10.4 score on a scale Interval 2.1 to 27.3
Overall Health and Disability 60-day outcome	22.7 score on a scale Interval 8.3 to 43.2	18.2 score on a scale Interval 6.3 to 31.8
Overall Health and Disability 365-day outcome	10.4 score on a scale Interval 2.1 to 29.2	8.3 score on a scale Interval 0.0 to 22.9

SECONDARY outcome

Timeframe: Approximately 60, 180, and 365 days after randomization

Population: This outcome was assessed among patients who were not admitted from a nursing home, rehabilitation facility, or acute care hospital. Denominator includes all known decedents at each time point, plus survivors providing information on location of residence at the time of study interview.

Will be assessed via telephone interview. Measure assessed as death or new transition to nursing home residence at each time point.

Outcome measures

Outcome measures
Measure	Regional Anesthesia n=613 Participants Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=625 Participants Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Ability to Return to Home 60-day outcomes	108 Participants	114 Participants
Ability to Return to Home 180-day outcomes	103 Participants	90 Participants
Ability to Return to Home 365-day outcomes	119 Participants	116 Participants

SECONDARY outcome

Timeframe: Approximately 60, 180, and 365 days after randomization

Population: Numbers differ across rows due to missing data

Will be assessed via the Numeric Rating Scale (NRS) and the need for prescription medications as evaluated during telephone interview. NRS values range from 0 to 10, with higher values indicating greater pain.

Outcome measures

Outcome measures
Measure	Regional Anesthesia n=315 Participants Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=320 Participants Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Chronic Pain 60-day measure	4.5 units on a scale Standard Deviation 3.2	4.2 units on a scale Standard Deviation 3.2
Chronic Pain 180-day measure	3.5 units on a scale Standard Deviation 3.3	3.4 units on a scale Standard Deviation 3.3
Chronic Pain 365-day measure	3.1 units on a scale Standard Deviation 3.2	3.2 units on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: Baseline and approximately 60, 180, and 365 days after randomization

Population: Numbers differ across rows due to missing data

Will be assessed via Short Blessed Test (SBT); SBT values range from 0 to 28, with higher scores indicating greater degrees of cognitive impairment.

Outcome measures

Outcome measures
Measure	Regional Anesthesia n=246 Participants Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=243 Participants Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Cognitive Function 60 day measure	2 units on a scale Interval 0.0 to 5.0	2 units on a scale Interval 0.0 to 6.0
Cognitive Function 180 day measure	2 units on a scale Interval 0.0 to 6.0	2 units on a scale Interval 0.0 to 6.0
Cognitive Function 365 day measure	2 units on a scale Interval 0.0 to 4.0	2 units on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Approximately 60, 180, and 365 days after randomization

Population: All enrolled patients who had not withdrawn or been lost to follow up a given study time point

Will be assessed via telephone interview and National Death Index (NDI) search

Outcome measures

Outcome measures
Measure	Regional Anesthesia n=768 Participants Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=784 Participants Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
All-cause Mortality 60-day outcomes	30 participants	32 participants
All-cause Mortality 180-day outcomes	69 participants	63 participants
All-cause Mortality 365-day outcomes	98 participants	92 participants

SECONDARY outcome

Timeframe: Approximately 60, 180, and 365 days after randomization

Population: 60-day outcome

Will be assessed via telephone interview

Outcome measures

Outcome measures
Measure	Regional Anesthesia n=672 Participants Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=694 Participants Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Need for Assistive Devices for Walking 60 day outcomes	403 Participants	397 Participants
Need for Assistive Devices for Walking 180 day outcomes	231 Participants	231 Participants
Need for Assistive Devices for Walking 365 day outcomes	196 Participants	193 Participants

SECONDARY outcome

Timeframe: Before surgery and daily through postoperative day 3 or day of discharge, whichever occurs first

Will be assessed via in-person interview using numeric rating scale (NRS). NRS values range from 0 to 10, with greater values indicating worse pain.

Outcome measures

Outcome measures
Measure	Regional Anesthesia n=706 Participants Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=722 Participants Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Acute Postoperative Pain Postoperative day 1	7.9 units on a scale Standard Deviation 2.6	7.6 units on a scale Standard Deviation 2.8
Acute Postoperative Pain Postoperative day 2	7.1 units on a scale Standard Deviation 2.7	7.1 units on a scale Standard Deviation 2.8
Acute Postoperative Pain Postoperative day 3	6.8 units on a scale Standard Deviation 2.9	6.6 units on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: Postoperative day 3 or day of discharge, whichever occurs first

Will be assessed via Bauer Patient Satisfaction Questionnaire. Data reported here corresponds to a response of "dissatisfied" or "very dissatisfied" to one or more of 5 Bauer questionnaire items assessing the following domains: information given by anesthesiologist before surgery; waking up from anesthesia; pain therapy after surgery; treatment of nausea and vomiting after surgery; care provided by department of anesthesia in general.

Outcome measures

Outcome measures
Measure	Regional Anesthesia n=647 Participants Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=661 Participants Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Satisfaction With Care	85 Participants	97 Participants

SECONDARY outcome

Timeframe: Baseline and daily through postoperative day 3 or day of discharge, whichever occurs first

Population: This outcome was assessed only among patients who had a negative 3D-CAM assessment for delirium before randomization.

Will be assessed via 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) assessment tool. Any positive 3D-CAM screen over the first 3 postoperative days in a patient with a negative pre-randomization screen was counted as a case of incident delirium.

Outcome measures

Outcome measures
Measure	Regional Anesthesia n=633 Participants Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=629 Participants Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Postoperative Delirium	130 Participants	124 Participants

SECONDARY outcome

Timeframe: During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first

Will be assessed via medical chart review. Data reported here on inpatient mortality.

Outcome measures

Outcome measures
Measure	Regional Anesthesia n=782 Participants Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=790 Participants Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Inpatient Mortality	5 Participants	13 Participants

SECONDARY outcome

Timeframe: During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first

Indicates occurrence of any of 12 complications based on medical record review: Myocardial infarction; Nonfatal cardiac arrest; Stroke; Pneumonia; Pulmonary edema; Pulmonary embolism; Unplanned postoperative intubation; Surgical-site infection; Urinary tract infection; Any return to the operating room; Critical care admission; Acute kidney injury.

Outcome measures

Outcome measures
Measure	Regional Anesthesia n=795 Participants Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=805 Participants Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Major Inpatient Morbidity	98 Participants	120 Participants

Adverse Events

Regional Anesthesia

Serious events: 255 serious events

Other events: 278 other events

Deaths: 98 deaths

General Anesthesia

Serious events: 242 serious events

Other events: 286 other events

Deaths: 92 deaths

Serious adverse events

Other adverse events

Additional Information

Mark D. Neuman, MD, MSc (Principal Investigator)

University of Pennsylvania Perelman School of Medicine

Phone: 215-746-7468

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Regional Anesthesia n=795 participants at risk Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=805 participants at risk Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Infections and infestations Wound infection	0.38% 3/795 • Adverse data were collected for up to one year post-randomization.	0.25% 2/805 • Adverse data were collected for up to one year post-randomization.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.63% 5/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Gastrointestinal disorders Vomiting	0.25% 2/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
General disorders Death	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
General disorders Death NOS	7.8% 62/795 • Adverse data were collected for up to one year post-randomization.	8.3% 67/805 • Adverse data were collected for up to one year post-randomization.
General disorders Edema limbs	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
General disorders Facial pain	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
General disorders Fatigue	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
General disorders Fever	0.50% 4/795 • Adverse data were collected for up to one year post-randomization.	0.37% 3/805 • Adverse data were collected for up to one year post-randomization.
General disorders Flu like symptoms	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
General disorders Gait disturbance	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.25% 2/805 • Adverse data were collected for up to one year post-randomization.
General disorders Multi-organ failure	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
General disorders Pain	0.50% 4/795 • Adverse data were collected for up to one year post-randomization.	0.50% 4/805 • Adverse data were collected for up to one year post-randomization.
General disorders Weakness	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
General disorders Weakness generalized	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Hepatobiliary disorders Cholecystitis	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Hepatobiliary disorders Gallbladder obstruction	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Hepatobiliary disorders Ischemic hepatitis	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Hepatobiliary disorders Obstructive jaundice	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Acute diverticulitis	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Bacteremia	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Bone infection	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Cellulitis	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.25% 2/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Cystitis bacterial	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Device related infection	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Enterocolitis infectious	0.38% 3/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Gastroenteritis	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Incision site infection	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Infection NOS	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Joint infection	0.25% 2/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Kidney infection	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Klebsiella pneumonia	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Lung infection	0.38% 3/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Osteomyelitis	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Pneumonia	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.37% 3/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Pneumonia pseudomonal	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Post procedural pneumonia	1.1% 9/795 • Adverse data were collected for up to one year post-randomization.	1.1% 9/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Post procedural site wound infection	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Pyelonephritis	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Infections and infestations Sepsis	1.3% 10/795 • Adverse data were collected for up to one year post-randomization.	0.50% 4/805 • Adverse data were collected for up to one year post-randomization.

Other adverse events
Measure	Regional Anesthesia n=795 participants at risk Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.	General Anesthesia n=805 participants at risk Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
Renal and urinary disorders Hydronephrosis	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Renal and urinary disorders Renal calculi	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Renal and urinary disorders Renal cyst	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Renal and urinary disorders Retention urinary	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Renal and urinary disorders Urinary frequency	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Blood and lymphatic system disorders Anemia	9.2% 73/795 • Adverse data were collected for up to one year post-randomization.	9.3% 75/805 • Adverse data were collected for up to one year post-randomization.
Blood and lymphatic system disorders Anemia iron deficiency	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Blood and lymphatic system disorders Hemolysis	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Blood and lymphatic system disorders Hemolytic uremic syndrome	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Blood and lymphatic system disorders Hypoplastic marrow	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Blood and lymphatic system disorders Leukocytosis	1.3% 10/795 • Adverse data were collected for up to one year post-randomization.	1.2% 10/805 • Adverse data were collected for up to one year post-randomization.
Blood and lymphatic system disorders Spleen disorder	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Blood and lymphatic system disorders Thrombocytosis	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.25% 2/805 • Adverse data were collected for up to one year post-randomization.
Cardiac disorders Aortic valve disease	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Cardiac disorders Atrial fibrillation	0.63% 5/795 • Adverse data were collected for up to one year post-randomization.	0.50% 4/805 • Adverse data were collected for up to one year post-randomization.
Cardiac disorders Chest pain - cardiac	1.1% 9/795 • Adverse data were collected for up to one year post-randomization.	0.25% 2/805 • Adverse data were collected for up to one year post-randomization.
Cardiac disorders Coronary artery disease	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Cardiac disorders Heart failure	0.38% 3/795 • Adverse data were collected for up to one year post-randomization.	0.25% 2/805 • Adverse data were collected for up to one year post-randomization.
Cardiac disorders Heart failure, congestive	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Cardiac disorders Non-sustained ventricular tachycardia	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Cardiac disorders Paroxysmal atrial tachycardia	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Cardiac disorders Pericardial effusion	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Cardiac disorders Sinus bradycardia	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Cardiac disorders Sinus tachycardia	1.6% 13/795 • Adverse data were collected for up to one year post-randomization.	0.87% 7/805 • Adverse data were collected for up to one year post-randomization.
Cardiac disorders Supraventricular tachycardia	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Cardiac disorders Ventricular tachycardia	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Congenital, familial and genetic disorders Phimosis	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Congenital, familial and genetic disorders Urachal abnormality	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Ear and labyrinth disorders Hearing impaired	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Ear and labyrinth disorders Vertigo	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Endocrine disorders Euthyroid sick syndrome	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Endocrine disorders Hyperparathyroidism	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Endocrine disorders Hyperthyroidism	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Endocrine disorders Hypothyroidism	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Eye disorders Cataract	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.37% 3/805 • Adverse data were collected for up to one year post-randomization.
Eye disorders Glaucoma	0.00% 0/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.
Eye disorders Macular degeneration	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.00% 0/805 • Adverse data were collected for up to one year post-randomization.
Gastrointestinal disorders Abdominal distension	0.13% 1/795 • Adverse data were collected for up to one year post-randomization.	0.12% 1/805 • Adverse data were collected for up to one year post-randomization.