Effectiveness of Celecoxib After Surgical Sperm Retrieval

NCT ID: NCT01323595

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-03-31

Brief Summary

While narcotic medication are commonly used for pain control near the time of surgery, there are significant side effects including constipation, nausea, risk of overdose leading to decreased breathing, and risk of addiction to narcotics. Our goal is to explore alternatives to narcotics for perioperative pain for patients undergoing sperm retrieval surgery. We have designed a prospective randomized clinical trial to evaluate how effective the anti-inflammatory medicine celecoxib(Celebrex©) is for pain control near the time of surgery. Celecoxib is known as a COX-2 inhibitor, a drug that belongs to the non-steroidal anti-inflammatory drug (NSAID) class. It is used to reduce swelling and to treat pain.

Patients will be divided into two groups: the first group receives a celecoxib pill and the second group receives a sugar pill(placebo). Patients and doctors will be unaware of exactly which pills are given. The patient will complete questionnaires for pain level. By comparing the pain levels we can better understand whether celecoxib (Celebrex©) significantly decreases perioperative pain.

Detailed Description

All consecutive patients scheduled to undergo elective, outpatient microsurgical testicular sperm extraction (TESE) beginning in 9/2011 will be invited for participation. Microdissection TESE will be performed unilaterally or bilaterally, through a midline scrotal incision, under general anesthesia.

Participants will be prospectively randomized in a 1:1 ratio to receive 200 mg of celecoxib or placebo b.i.d. in a double-blind fashion, initiated the night prior to surgery, and continued for six days thereafter. The randomization sequence will be generated and implemented by the institutional investigational pharmacy. Placebo medication, identical to the study medication, will also be provided by the institutional pharmacy.

Following surgery, all participants will be asked to complete a take-home post-operative questionnaire recording their maximum pain level on an 11-point visual analog scale (0-10), at specific time intervals over the course of the day, ranging from every six hours on post-operative day (POD) #1 to every 8 hours on POD #2, every 12 hours on POD #3, and every 24 hours on POD #4 to POD #7. Patients will also record the number of 5/500 mg tablets of acetaminophen/hydrocodone used for supplemental pain control from POD #1 to POD #7. Thirdly, patients will record whether or not their pain was adequately controlled at each of the above-mentioned time intervals.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Celecoxib

Celecoxib will be given for 6 days after surgery

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

Celecoxib 200mg PO BID x 6 days

Sugar pill

Sugar pill for 6 days after surgery.

Group Type: PLACEBO_COMPARATOR

Sugar Pill

Intervention Type: DRUG

Sugar pill PO BID x 6 days

Interventions

Celecoxib

Celecoxib 200mg PO BID x 6 days

Intervention Type: DRUG

Sugar Pill

Sugar pill PO BID x 6 days

Intervention Type: DRUG

Other Intervention Names

Celebrex; Placebo

Eligibility Criteria

Inclusion Criteria

1. >/= 18 years old

2. Male

3. Scheduled to undergo microdissection testicular sperm extraction

Exclusion Criteria

1. History of allergies to celecoxib (Celecoxib)

2. Renal failure

3. History of ulcer disease

4. Any history of myocardial infarction

5. Any history of stroke

6. History of bleeding diathesis

7. Use of aspirin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter N Schlegel, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Department of Urology, Weill Cornell Medical College,

New York, New York, United States

Countries

United States

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/23628190

Study Abstract

Other Identifiers

1010011319

Identifier Type: -

Identifier Source: org_study_id