Trial Outcomes & Findings for General or Regional Anesthesia for Hip Surgery (NCT NCT01733472)

Results Overview

Time from the end of surgery until the patients meets the discharge criteria will be evaluated. Discharge criteria: able to get in and out of bed, Able to get dressed. Able to sit down in a chair and get up again. Able to walk 50 meters wit/without crutches. Able to flex knee 70 degrees. Able to walk stairs. Pain manageable with oral analgesics. Acceptance to be discharged

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

Up to 4 days after surgery

Results posted on

2019-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	RA-arm RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg placebo	GA-arm, Remifentanil GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm
Overall Study STARTED	60	60
Overall Study COMPLETED	60	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

General or Regional Anesthesia for Hip Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RA-arm n=60 Participants RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg placebo	GA-arm, Remifentanil n=60 Participants GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=93 Participants	40 Participants n=4 Participants	80 Participants n=27 Participants
Age, Categorical >=65 years	20 Participants n=93 Participants	20 Participants n=4 Participants	40 Participants n=27 Participants
Age, Continuous	68 years STANDARD_DEVIATION 9 • n=93 Participants	66 years STANDARD_DEVIATION 8 • n=4 Participants	67 years STANDARD_DEVIATION 8 • n=27 Participants
Sex/Gender, Customized Female	29 participants n=93 Participants	31 participants n=4 Participants	60 participants n=27 Participants
Sex/Gender, Customized Male	31 participants n=93 Participants	29 participants n=4 Participants	60 participants n=27 Participants
Region of Enrollment Sweden	60 participants n=93 Participants	60 participants n=4 Participants	120 participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 4 days after surgery

Population: Two patients in the RA group were excluded because of the conversion to general anaesthesia.

Time from the end of surgery until the patients meets the discharge criteria will be evaluated. Discharge criteria: able to get in and out of bed, Able to get dressed. Able to sit down in a chair and get up again. Able to walk 50 meters wit/without crutches. Able to flex knee 70 degrees. Able to walk stairs. Pain manageable with oral analgesics. Acceptance to be discharged

Outcome measures

Outcome measures
Measure	RA-arm n=58 Participants RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg placebo	GA-arm, Remifentanil n=60 Participants GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm
Length of Hospital Stay	30 hours Interval 25.0 to 45.0	26 hours Interval 23.0 to 30.0

SECONDARY outcome

Timeframe: from end of surgey until 48 hrs later

Population: Two patients in the RA group were excluded because of the conversion to general anaesthesia.

Pain will be monitored using a Visual Analogue Scale. Pain will be monitored with the patient in four different positions. VAS 100 mm used for assessment of pain (0 = no pain, 100 = worst imaginable pain). At each time and position the median VAS-pain score was reported (generally the distribution of pain scores are not normally distributed and hence median value was used)

Outcome measures

Outcome measures
Measure	RA-arm n=58 Participants RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg placebo	GA-arm, Remifentanil n=60 Participants GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm
Post Operative Pain	35 score on a scale Interval 20.0 to 50.0	25 score on a scale Interval 0.0 to 35.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 hrs

Population: Two patients in the RA group were excluded because of the conversion to general anaesthesia.

Hours until the patient meets the discharge criteria from PACU will be monitored every 15 min from teh time the patient arrives to PACU until he/she meets the discharge criteria

Outcome measures

Outcome measures
Measure	RA-arm n=58 Participants RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg placebo	GA-arm, Remifentanil n=60 Participants GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm
Time Hrs Until the Patient Meets the Discharge Criteria From PACU	4 hours Interval 3.0 to 5.0	3 hours Interval 2.0 to 4.0

Adverse Events

RA-arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

GA-arm, Remifentanil

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RA-arm n=60 participants at risk RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg placebo	GA-arm, Remifentanil n=60 participants at risk GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm
Cardiac disorders atrial fibrillation	1.7% 1/60 • Number of events 1	1.7% 1/60 • Number of events 1

Additional Information

Andreas Harsten

Region Skane

Phone: 46708870567

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place