Trial Outcomes & Findings for Spinal Anesthesia in Total Hip Arthroplasty (NCT NCT02818894)

Results Overview

Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

135 participants

Primary outcome timeframe

Day 1 (day of surgery) Post-Operation

Results posted on

2022-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Lidocaine Spinal Anesthesia Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.	Bupivacaine Spinal Anesthesia Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.
Overall Study STARTED	67	68
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	56	56

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine Spinal Anesthesia n=67 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.	Bupivacaine Spinal Anesthesia n=68 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.	Total n=135 Participants Total of all reporting groups
Age, Continuous	61.08 years STANDARD_DEVIATION 11.056 • n=67 Participants	61.22 years STANDARD_DEVIATION 10.98 • n=68 Participants	61.13 years STANDARD_DEVIATION 11.04 • n=135 Participants
Sex: Female, Male Female	37 Participants n=67 Participants	29 Participants n=68 Participants	66 Participants n=135 Participants
Sex: Female, Male Male	30 Participants n=67 Participants	39 Participants n=68 Participants	69 Participants n=135 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	67 participants n=67 Participants	68 participants n=68 Participants	135 participants n=135 Participants

PRIMARY outcome

Timeframe: Day 1 (day of surgery) Post-Operation

Population: This analysis includes participants who completed the Neurological Symptoms Checklist. Two participants were assessed for other outcomes post-operatively on day of surgery but TNS was not evaluated. Sixteen participants were not assessed post-operatively on day of surgery for any outcomes, or their records were lost. Details about some study visits are no longer available and the exact reasons for the missing data cannot be determined.

Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.

Outcome measures

Outcome measures
Measure	Lidocaine Spinal Anesthesia n=48 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.	Bupivacaine Spinal Anesthesia n=50 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.
Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 Post-Operation	3 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 (day of surgery) Post-Operation

Population: This analysis includes participants reporting any type of TNS following surgery, on the day of surgery.

Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.

Outcome measures

Outcome measures
Measure	Lidocaine Spinal Anesthesia n=3 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.	Bupivacaine Spinal Anesthesia n=1 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.
Post-Operative Transient Neurological Symptoms Score on Day 1 Post-Operation	2 score on a scale Standard Deviation 1.0	4 score on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: Post-Operative Day 7

Population: This analysis includes participants who completed the Neurological Symptoms Checklist. One participant in the lidocaine group participated in the Post-Operative Day 7 follow-up phone call but did not complete the Neurological Symptoms Checklist. The remaining missing participants were lost to follow up, were not called for this follow-up assessment, or their records were lost. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.

Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.

Outcome measures

Outcome measures
Measure	Lidocaine Spinal Anesthesia n=14 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.	Bupivacaine Spinal Anesthesia n=17 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.
Number of Participants With Transient Neurological Symptoms on Post-Operative Day 7	3 Participants	4 Participants

PRIMARY outcome

Timeframe: Post-Operative Day 7

Population: This analysis includes participants reporting any type of TNS during the Post-Operative Day 7 follow-up assessment.

Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.

Outcome measures

Outcome measures
Measure	Lidocaine Spinal Anesthesia n=3 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.	Bupivacaine Spinal Anesthesia n=4 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.
Transient Neurological Symptoms Score on Post-Operative Day 7	2.33 score on a scale Standard Deviation 2.52	5.75 score on a scale Standard Deviation 4.19

PRIMARY outcome

Timeframe: Post-Operative Day 14

Population: This analysis includes participants who completed the Neurological Symptoms Checklist. Thirteen participants in the Bupivacaine group participated in the Post-Operative Day 14 follow-up phone call but only 12 completed the TNS assessment. The remaining missing participants were lost to follow up, were not called for the Post-Operative Day 14 assessment, or their records were lost. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.

Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain not associated with the operation area. The count of participants reporting any type of TNS is presented here.

Outcome measures

Outcome measures
Measure	Lidocaine Spinal Anesthesia n=11 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.	Bupivacaine Spinal Anesthesia n=12 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.
Number of Participants With Transient Neurological Symptoms on Post-Operative Day 14	9 Participants	3 Participants

PRIMARY outcome

Timeframe: Post-Operative Day 14

Population: This analysis includes participants reporting any type of TNS following surgery on Post-Operative Day 14.

Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.

Outcome measures

Outcome measures
Measure	Lidocaine Spinal Anesthesia n=9 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.	Bupivacaine Spinal Anesthesia n=3 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.
Transient Neurological Symptoms Score on Post-Operative Day 14	2.56 score on a scale Standard Deviation 1.88	5.67 score on a scale Standard Deviation 3.06

SECONDARY outcome

Timeframe: Day 1 (day of surgery) Post-Operation

Population: This analysis includes participants who had data regarding urinary voiding recorded. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.

Urine retention after recovery from spinal anesthesia was assessed as the count of participants voiding without complications. Data were obtained through review of the inpatient records.

Outcome measures

Outcome measures
Measure	Lidocaine Spinal Anesthesia n=48 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.	Bupivacaine Spinal Anesthesia n=50 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.
Number of Participants Voiding Without Complications After Recovery From Spinal Anesthesia	47 Participants	47 Participants

SECONDARY outcome

Timeframe: Day 1 (day of surgery) Post-Operation

Population: This analysis includes participants who had the time when they were fully ambulatory recorded. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.

Time to ambulation after recovery from spinal anesthesia is assessed in minutes. Information about time to full ambulation was obtained by asking participants or from inpatient medical charts.

Outcome measures

Outcome measures
Measure	Lidocaine Spinal Anesthesia n=47 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.	Bupivacaine Spinal Anesthesia n=49 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.
Time to Ambulation After Recovery From Spinal Anesthesia	279.3 minutes Standard Deviation 273.0	242.0 minutes Standard Deviation 91.23

SECONDARY outcome

Timeframe: Day 1 (day of surgery) Post-Operation

Population: This analysis includes participants with post-operative blood pressure data recorded. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.

The number of participants experiencing hypotension, defined as systolic blood pressure of \<90 mmHg, is presented here. Blood pressure information was obtained from reviewing the inpatient medical charts.

Outcome measures

Outcome measures
Measure	Lidocaine Spinal Anesthesia n=49 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.	Bupivacaine Spinal Anesthesia n=51 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.
Count of Participants With Hypotension	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Post-Operative Day 2

Population: This analysis includes participants with discharge data collected from medical records. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.

Hospital length of stay was obtained from inpatient charts. Length of stay was determined using the hospital admission dates and discharge dates, and was then categorized as being discharged the same day as the surgery, the day after surgery, or two days after surgery.

Outcome measures

Outcome measures
Measure	Lidocaine Spinal Anesthesia n=49 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia.	Bupivacaine Spinal Anesthesia n=51 Participants Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia.
Number of Participants Discharged 0, 1, or 2 Days Following Surgery Post-operative Day 2	4 Participants	1 Participants
Number of Participants Discharged 0, 1, or 2 Days Following Surgery Day of surgery	35 Participants	44 Participants
Number of Participants Discharged 0, 1, or 2 Days Following Surgery Post-operative Day 1	10 Participants	6 Participants

Adverse Events

Lidocaine Spinal Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine Spinal Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas L. Bradbury, MD

Emory University

Phone: 404-759-3912

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place