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

NCT03802864 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1802018993
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain Scores 60 Hours After Surgery

  First 60 hours after surgery

• Pain Scores 7 Days After Surgery

  First 7 days after surgery

• Narcotic Requirement

  First 7 days after surgery

• Time to Narcotic Rescue

  First 7 days after surgery

• Pain Control Satisfaction

  7th day after surgery

Study Arms (2)

Liposomal Bupivacaine

EXPERIMENTAL

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

Standard Bupivacaine

ACTIVE COMPARATOR

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

Interventions

Liposomal Bupivacaine DRUG

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.

Liposomal Bupivacaine

Standard Bupivacaine DRUG

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

Standard Bupivacaine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Weill Cornell Medicine Department of Urology

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Results Point of Contact

• Title: Russell Hayden
• Organization: Weill Cornell Medicine

rph9002@med.cornell.edu

2127465566

Study Officials

• Russell Hayden, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study model is a randomized double blind control trial.

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 14, 2019
• Study Start: February 4, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)