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

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 4

Conditions: Male Infertility

Treatments: Drug: Liposomal Bupivacaine; Drug: Standard Bupivacaine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03802864

1802018993

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Liposomal Bupivacaine

Experimental group

Description:

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.

Treatment:

Drug: Liposomal Bupivacaine

Standard Bupivacaine

Active Comparator group

Description:

Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.

Treatment:

Drug: Standard Bupivacaine