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

NCT03802864 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-12-17

Study results available
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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

Interventions

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.

DRUG

Standard Bupivacaine

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

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Russell Hayden, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2020-01-30
Completion
2020-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03802864 on ClinicalTrials.gov