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

Phase 4

Completed

Conditions: Male Infertility

Interventions: Drug: Standard Bupivacaine
Drug: Liposomal Bupivacaine

Registration Number: NCT03802864

Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Bupivacaine	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.
Liposomal Bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Pain Scores 48 Hours After Surgery	First 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).

Secondary Outcome Measures

Name	Time	Method
Pain Scores 7 Days After Surgery	First 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).
Pain Scores 60 Hours After Surgery	First 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).
Narcotic Requirement	First 7 days after surgery	Total number of narcotic tablets required between the intervention and control arms during post-operative day 1 through 7.
Time to Narcotic Rescue	First 7 days after surgery	Time (in hours) to first rescue narcotic utilization between the two arms.
Percentage of Patients Not Requiring Any Narcotics	7th day after surgery	The percentage of patients remaining opiate free by post-operative day 7.
Pain Control Satisfaction	7th day after surgery	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.