Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine

Male Infertility Clinical Trial

Official title:

Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03802864
• Other study ID #: 1802018993
• Status: Completed
• Phase: Phase 4
• Start date: February 4, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: November 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Men scheduled for surgical sperm retrieval for infertility

• Men 18 years and older who can provide informed consent

• No documented allergy to bupivacaine or celecoxib

Exclusion Criteria:

• Prior history of substance abuse

• Any narcotic use within the last 3 months

• Concomitant use of aspirin

• Any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses

• Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility
• Pain, Postoperative

Intervention

Drug:
• 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
After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine Department of Urology	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	First 48 hours after surgery
Secondary	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).	First 60 hours after surgery
Secondary	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).	First 7 days after surgery
Secondary	Narcotic Requirement	Total number of narcotic tablets required between the intervention and control arms during post-operative day 1 through 7.	First 7 days after surgery
Secondary	Time to Narcotic Rescue	Time (in hours) to first rescue narcotic utilization between the two arms.	First 7 days after surgery
Secondary	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.	7th day after surgery
Secondary	Percentage of Patients Not Requiring Any Narcotics	The percentage of patients remaining opiate free by post-operative day 7.	7th day after surgery