Clinical trial NCT01323595: Effectiveness of Celecoxib After Surgical Sperm Retrieval
Official title: The Use of Celecoxib (Celebrex (c)) in Post-operative Pain Control After Microdissection Testicular Sperm Extraction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: Pain control
testicular sperm extraction
sperm
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 78
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Level of Pain
timeFrame: 1 week after surgery
Secondary outcomes:
measure: Number of Participants With Bleeding Complications
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Urology, Weill Cornell Medical College,
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Peter N Schlegel, MD
role: PRINCIPAL_INVESTIGATOR
References: