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

Study Overview
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Brief Summary
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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.

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

Conditions
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Male Infertility

Intervention / Treatment
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* Drug: Liposomal Bupivacaine
* Drug: Standard Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study model is a randomized double blind control trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Bupivacaine<br>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<br>* 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.<br>|
| Active Comparator: Standard Bupivacaine<br>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<br>* After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Time to Narcotic Rescue | Time (in hours) to first rescue narcotic utilization between the two arms. | 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. | 7th day after surgery | 
| Percentage of Patients Not Requiring Any Narcotics | The percentage of patients remaining opiate free by post-operative day 7. | 7th day after surgery |