Effectiveness of Celecoxib After Surgical Sperm Retrieval
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|ClinicalTrials.gov Identifier: NCT01323595|
Recruitment Status : Terminated (Interim analysis demonstrated significant benefit in intervention arm)
First Posted : March 25, 2011
Results First Posted : July 11, 2014
Last Update Posted : December 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Celecoxib Drug: Sugar Pill||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Use of Celecoxib (Celebrex (c)) in Post-operative Pain Control After Microdissection Testicular Sperm Extraction|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||March 2013|
Celecoxib will be given for 6 days after surgery
Celecoxib 200mg PO BID x 6 days
Other Name: Celebrex
Placebo Comparator: Sugar pill
Sugar pill for 6 days after surgery.
Drug: Sugar Pill
Sugar pill PO BID x 6 days
Other Name: Placebo
- Level of Pain [ Time Frame: 1 week after surgery ]Patients will rate their pain for 7 days after surgery using an 11-point visual analog scale (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.
- Bleeding Complications [ Time Frame: 7 days after surgery ]We will record whether there are any bleeding complications associated with treatment after surgery.
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): NCT01323595
|United States, New York|
|Department of Urology, Weill Cornell Medical College,|
|New York, New York, United States, 10065|
|Principal Investigator:||Peter N Schlegel, MD||Weill Medical College of Cornell University|