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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802864
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief 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.

Condition or disease Intervention/treatment Phase
Male Infertility Drug: Liposomal Bupivacaine Drug: Standard Bupivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study model is a randomized double blind control trial.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
Actual Study Start Date : February 4, 2019
Actual Primary Completion Date : January 30, 2020
Actual Study Completion Date : January 30, 2020


Arm Intervention/treatment
Experimental: 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.
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.

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




Primary Outcome Measures :
  1. Pain scores 48 hours after surgery [ Time Frame: First 48 hours after surgery ]
    Area under the curve of pain rankings on the 11-point numerical pain rating scales (0 indicating no pain and 10 indicating worst possible pain) assessed every 8 hours in the first 48 hours post-surgery.


Secondary Outcome Measures :
  1. Pain scores 60 hours after surgery [ Time Frame: First 60 hours after surgery ]
    Area under the curve of pain rankings on the 11-point numerical pain rating scales (0 indicating no pain and 10 indicating worst possible pain) assessed twice daily in the first 60 hours post-surgery.

  2. Pain scores 7 days after surgery [ Time Frame: First 7 days after surgery ]
    Area under the curve of pain rankings on the 11-point numerical pain rating scales (0 indicating no pain and 10 indicating worst possible pain) assessed twice daily in the first 7 days post-surgery.

  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 will be 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802864


Locations
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United States, New York
Weill Cornell Medicine Department of Urology
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Pacira Pharmaceuticals, Inc
Investigators
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Principal Investigator: Russell Hayden, MD Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03802864    
Other Study ID Numbers: 1802018993
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents