Phase 4 N=50 Randomized Triple-blind Treatment

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

Male Infertility

Bottom Line

View on ClinicalTrials.gov: NCT03802864 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcome: Primary: Pain Scores 48 Hours After Surgery — 118.4; 98.2 Scores*Hour — p=0.41

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Liposomal Bupivacaine (Drug); Standard Bupivacaine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Weill Medical College of Cornell University
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Scores 48 Hours After Surgery	118.4; 98.2	0.41
SECONDARY Pain Scores 60 Hours After Surgery	140.7; 116	0.37
SECONDARY Pain Scores 7 Days After Surgery	286.6; 233.1	0.36
SECONDARY Narcotic Requirement	2.6; 1.6	0.28
SECONDARY Time to Narcotic Rescue	10; 8; 0; 0; 0; 3	0.78
SECONDARY Pain Control Satisfaction	22; 20; 0; 1	0.49
SECONDARY Percentage of Patients Not Requiring Any Narcotics	15; 16; 10; 9	0.99

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03802864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.