Trial Outcomes & Findings for Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine (NCT NCT03802864)
NCT ID: NCT03802864
Last Updated: 2020-12-17
Results Overview
Every 8 hours in the first 48 hours post-surgery, subjects were prompted to report their pain score on the 11-point numerical pain rating scale, NRS-11 (Numerical Rating Scale, 11 points). 0 indicates no pain and 10 indicates worst possible pain. Each subject's pain scores were then plotted against time, and the area under the curve was then computed. The minimum composite score would be 0 (no pain ever reported), and the maximum composite score would be 480 (maximum pain (score of 10) reported each time across 48 hours).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
First 48 hours after surgery
Results posted on
2020-12-17
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine
Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
|
Standard Bupivacaine
Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
|
Standard Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
|
Total
n=50 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
37.2 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
36.4 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
36.8 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First 48 hours after surgeryEvery 8 hours in the first 48 hours post-surgery, subjects were prompted to report their pain score on the 11-point numerical pain rating scale, NRS-11 (Numerical Rating Scale, 11 points). 0 indicates no pain and 10 indicates worst possible pain. Each subject's pain scores were then plotted against time, and the area under the curve was then computed. The minimum composite score would be 0 (no pain ever reported), and the maximum composite score would be 480 (maximum pain (score of 10) reported each time across 48 hours).
Outcome measures
| Measure |
Liposomal Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
|
Standard Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
|
|---|---|---|
|
Pain Scores 48 Hours After Surgery
|
118.4 Scores*Hour
Standard Deviation 99.7
|
98.2 Scores*Hour
Standard Deviation 68.9
|
SECONDARY outcome
Timeframe: First 60 hours after surgeryEvery 12 hours in the first 60 hours post-surgery, subjects were prompted to report their pain score on the 11-point numerical pain rating scale, NRS-11 (Numerical Rating Scale, 11 points). 0 indicates no pain and 10 indicates worst possible pain. Each subject's pain scores were then plotted against time, and the area under the curve was then computed. The minimum composite score would be 0 (no pain ever reported), and the maximum composite score would be 600 (maximum pain (score of 10) reported each time across 60 hours).
Outcome measures
| Measure |
Liposomal Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
|
Standard Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
|
|---|---|---|
|
Pain Scores 60 Hours After Surgery
|
140.7 Scores*Hour
Standard Deviation 107.8
|
116 Scores*Hour
Standard Deviation 83.2
|
SECONDARY outcome
Timeframe: First 7 days after surgeryEvery 12 hours in the first 7 days post-surgery, subjects were prompted to report their pain score on the 11-point numerical pain rating scale, NRS-11 (Numerical Rating Scale, 11 points). 0 indicates no pain and 10 indicates worst possible pain. Each subject's pain scores were then plotted against time, and the area under the curve was then computed. The minimum composite score would be 0 (no pain ever reported), and the maximum composite score would be 1680 (maximum pain (score of 10) reported each time across 168 hours).
Outcome measures
| Measure |
Liposomal Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
|
Standard Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
|
|---|---|---|
|
Pain Scores 7 Days After Surgery
|
286.6 Scores*Hour
Standard Deviation 202.7
|
233.1 Scores*Hour
Standard Deviation 209.9
|
SECONDARY outcome
Timeframe: First 7 days after surgeryTotal number of narcotic tablets required between the intervention and control arms during post-operative day 1 through 7.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
|
Standard Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
|
|---|---|---|
|
Narcotic Requirement
|
2.6 Count of narcotic tablets
Standard Deviation 4.4
|
1.6 Count of narcotic tablets
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: First 7 days after surgeryTime (in hours) to first rescue narcotic utilization between the two arms.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
|
Standard Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
|
|---|---|---|
|
Time to Narcotic Rescue
0 to 40 Hours After Surgery
|
10 Participants
|
8 Participants
|
|
Time to Narcotic Rescue
41 to 80 Hours After Surgery
|
0 Participants
|
0 Participants
|
|
Time to Narcotic Rescue
81 to 120 Hours After Surgery
|
0 Participants
|
3 Participants
|
|
Time to Narcotic Rescue
121 to 160 Hours After Surgery
|
2 Participants
|
1 Participants
|
|
Time to Narcotic Rescue
Never Required Narcotics
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 7th day after surgeryPopulation: 3 subjects from the Liposomal Bupivacaine arm and 4 subjects from the Standard Bupivacaine arm weren't analyzed because they didn't provide answers to the yes/no prompt.
Overall satisfaction of pain control regimen self reported on post-operative day 7. The prompt required a yes/no answer. The percent of participants answering "yes" will be compared between the two arms.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=22 Participants
Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
|
Standard Bupivacaine
n=21 Participants
Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
|
|---|---|---|
|
Pain Control Satisfaction
Yes - Adequate pain control achieved
|
22 Participants
|
20 Participants
|
|
Pain Control Satisfaction
No - Adequate pain control not achieved
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7th day after surgeryThe percentage of patients remaining opiate free by post-operative day 7.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
|
Standard Bupivacaine
n=25 Participants
Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
|
|---|---|---|
|
Percentage of Patients Not Requiring Any Narcotics
No narcotics required
|
15 Participants
|
16 Participants
|
|
Percentage of Patients Not Requiring Any Narcotics
Narcotics required
|
10 Participants
|
9 Participants
|
Adverse Events
Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Standard Bupivacaine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liposomal Bupivacaine
n=25 participants at risk
Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Liposomal Bupivacaine: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
|
Standard Bupivacaine
n=25 participants at risk
Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
Standard Bupivacaine: After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
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|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/25 • Subjects were monitored for adverse events from the time of their initial surgery until 3 weeks after surgery.
|
8.0%
2/25 • Number of events 2 • Subjects were monitored for adverse events from the time of their initial surgery until 3 weeks after surgery.
|
|
Gastrointestinal disorders
Constipation
|
8.0%
2/25 • Number of events 2 • Subjects were monitored for adverse events from the time of their initial surgery until 3 weeks after surgery.
|
4.0%
1/25 • Number of events 1 • Subjects were monitored for adverse events from the time of their initial surgery until 3 weeks after surgery.
|
|
Reproductive system and breast disorders
Scrotal Pain
|
0.00%
0/25 • Subjects were monitored for adverse events from the time of their initial surgery until 3 weeks after surgery.
|
4.0%
1/25 • Number of events 1 • Subjects were monitored for adverse events from the time of their initial surgery until 3 weeks after surgery.
|
|
Reproductive system and breast disorders
Scrotal infection
|
4.0%
1/25 • Number of events 1 • Subjects were monitored for adverse events from the time of their initial surgery until 3 weeks after surgery.
|
0.00%
0/25 • Subjects were monitored for adverse events from the time of their initial surgery until 3 weeks after surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place