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

NCT ID: NCT03802864

Last Updated: 2020-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2020-01-30

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.

Detailed Description

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Conditions

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Male Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study model is a randomized double blind control trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Liposomal Bupivacaine

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Standard Bupivacaine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Standard Bupivacaine

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Russell Hayden, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medicine Department of Urology

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1802018993

Identifier Type: -

Identifier Source: org_study_id