Effectiveness of Celecoxib After Surgical Sperm Retrieval

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of Celecoxib (Celebrex (c)) in Post-operative Pain Control After Microdissection Testicular Sperm Extraction

Conditions
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Pain

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Sugar Pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >/= 18 years old Male Scheduled to undergo microdissection testicular sperm extraction Exclusion Criteria: History of allergies to celecoxib (Celecoxib) Renal failure History of ulcer disease Any history of myocardial infarction Any history of stroke History of bleeding diathesis Use of aspirin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib<br>Celecoxib will be given for 6 days after surgery | Drug: Celecoxib<br>* Celecoxib 200mg PO BID x 6 days<br>* Other names: Celebrex;|
| Placebo Comparator: Sugar pill<br>Sugar pill for 6 days after surgery. | Drug: Sugar Pill<br>* Sugar pill PO BID x 6 days<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Pain | Patients will rate their pain for 7 days after surgery using an 11-point visual analog scale, ranging from 0 to 10, in which 0= no pain, 10=worst pain ever. Patients are asked to rate their pain up to four times a day during the post-operative period. Pain scores from each post-operative day each day will be averaged and reported as the pain score for that day. | 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Bleeding Complications | We will record whether there are any bleeding complications associated with treatment after surgery. | 7 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain control, testicular sperm extraction, sperm