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Completed

NCT Number: NCT03802864

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

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Weill Cornell Medicine Department of Urology

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Bupivacaine

Drug

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

Primary outcomes

  1. Pain Scores 48 Hours After Surgery

    Time frame: First 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).

Secondary outcomes

  1. Pain Scores 60 Hours After Surgery

    Time frame: First 60 hours after surgery

    Every 12 hours in the first 60 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 600 (maximum pain (score of 10) reported each time across 60 hours).

  2. Pain Scores 7 Days After Surgery

    Time frame: First 7 days after surgery

    Every 12 hours in the first 7 days 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 1680 (maximum pain (score of 10) reported each time across 168 hours).

  3. Narcotic Requirement

    Time frame: First 7 days after surgery

    Total number of narcotic tablets required between the intervention and control arms during post-operative day 1 through 7.

  4. Time to Narcotic Rescue

    Time frame: First 7 days after surgery

    Time (in hours) to first rescue narcotic utilization between the two arms.

  5. Pain Control Satisfaction

    Time frame: 7th day after surgery

    Overall satisfaction of pain control regimen self reported on post-operative day 7. The prompt required a yes/no answer. The percent of participants answering "yes" will be compared between the two arms.

  6. Percentage of Patients Not Requiring Any Narcotics

    Time frame: 7th day after surgery

    The percentage of patients remaining opiate free by post-operative day 7.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Pacira Pharmaceuticals, Inc

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2019
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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