A Phase 4 interventional study of Liposomal Bupivacaine and Standard Bupivacaine in Male Infertility, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to male participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Weill Medical College of Cornell University · Phase 4, Interventional, and Treatment
The study is a drug trial comparing the post-operative pain control provided by liposomal bupivacaine (a local anesthetic) against standard bupivacaine (a different formulation of the local anesthetic) for men undergoing testicular sperm extraction.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 50 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
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Exclusion Criteria:
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.
Drug: Liposomal 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.
Drug: Standard 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.
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
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).
Time frame: First 48 hours after surgery
Pain Scores 60 Hours After Surgery
Every 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).
Time frame: First 60 hours after surgery
Pain Scores 7 Days After Surgery
Every 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).
Time frame: First 7 days after surgery
Narcotic Requirement
Total number of narcotic tablets required between the intervention and control arms during post-operative day 1 through 7.
Time frame: First 7 days after surgery
Time to Narcotic Rescue
Time (in hours) to first rescue narcotic utilization between the two arms.
Time frame: First 7 days after surgery
Pain Control Satisfaction
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.
Time frame: 7th day after surgery
Percentage of Patients Not Requiring Any Narcotics
The percentage of patients remaining opiate free by post-operative day 7.
Time frame: 7th day after surgery
| Milestone | Liposomal Bupivacaine | Standard Bupivacaine |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
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).
| Scores*Hour | Liposomal Bupivacaine | Standard Bupivacaine |
|---|---|---|
| Pain Scores 48 Hours After Surgery | 118.4 ± 99.7 | 98.2 ± 68.9 |
Every 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).
| Scores*Hour | Liposomal Bupivacaine | Standard Bupivacaine |
|---|---|---|
| Pain Scores 60 Hours After Surgery | 140.7 ± 107.8 | 116 ± 83.2 |
Every 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).
| Scores*Hour | Liposomal Bupivacaine | Standard Bupivacaine |
|---|---|---|
| Pain Scores 7 Days After Surgery | 286.6 ± 202.7 | 233.1 ± 209.9 |
Total number of narcotic tablets required between the intervention and control arms during post-operative day 1 through 7.
| Count of narcotic tablets | Liposomal Bupivacaine | Standard Bupivacaine |
|---|---|---|
| Narcotic Requirement | 2.6 ± 4.4 | 1.6 ± 3.1 |
Time (in hours) to first rescue narcotic utilization between the two arms.
| Participants | Liposomal Bupivacaine | Standard Bupivacaine |
|---|---|---|
| 0 to 40 Hours After Surgery | 10 | 8 |
| 41 to 80 Hours After Surgery | 0 | 0 |
| 81 to 120 Hours After Surgery | 0 | 3 |
| 121 to 160 Hours After Surgery | 2 | 1 |
| Never Required Narcotics | 13 | 13 |
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.
| Participants | Liposomal Bupivacaine | Standard Bupivacaine |
|---|---|---|
| Yes - Adequate pain control achieved | 22 | 20 |
| No - Adequate pain control not achieved | 0 | 1 |
The percentage of patients remaining opiate free by post-operative day 7.
| Participants | Liposomal Bupivacaine | Standard Bupivacaine |
|---|---|---|
| No narcotics required | 15 | 16 |
| Narcotics required | 10 | 9 |
Collected over Subjects were monitored for adverse events from the time of their initial surgery until 3 weeks after surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Liposomal Bupivacaine | 0/25 (0%) | 0/25 (0%) | 3/25 (12%) |
| Standard Bupivacaine | 0/25 (0%) | 0/25 (0%) | 4/25 (16%) |
| Event | Liposomal Bupivacaine | Standard Bupivacaine |
|---|---|---|
| Back PainMusculoskeletal and connective tissue disorders | 0/25 | 2/25 |
| ConstipationGastrointestinal disorders | 2/25 | 1/25 |
| Scrotal PainReproductive system and breast disorders | 0/25 | 1/25 |
| Scrotal infectionReproductive system and breast disorders | 1/25 | 0/25 |
| Age, Continuous(years) | Liposomal Bupivacaine | Standard Bupivacaine | Total |
|---|---|---|---|
| Mean | 37.2 ± 9.3 | 36.4 ± 11.9 | 36.8 ± 10.6 |
| Sex: Female, Male(Participants) | Liposomal Bupivacaine | Standard Bupivacaine | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 25 | 25 | 50 |
| Ethnicity (NIH/OMB)(Participants) | Liposomal Bupivacaine | Standard Bupivacaine | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 24 | 25 | 49 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Liposomal Bupivacaine | Standard Bupivacaine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 4 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 22 | 19 | 41 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Liposomal Bupivacaine | Standard Bupivacaine | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
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Weill Medical College of Cornell University