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Effectiveness of Celecoxib After Surgical Sperm Retrieval

This study has been terminated.
(Interim analysis demonstrated significant benefit in intervention arm)
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01323595
First received: March 24, 2011
Last updated: June 10, 2014
Last verified: June 2014

March 24, 2011
June 10, 2014
January 2011
December 2012   (final data collection date for primary outcome measure)
Level of Pain [ Time Frame: 1 week after surgery ] [ Designated as safety issue: No ]
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.
Level of pain [ Time Frame: 1 week after surgery ] [ Designated as safety issue: No ]
Patients will rate their pain for 7 days after surgery.
Complete list of historical versions of study NCT01323595 on ClinicalTrials.gov Archive Site
Bleeding Complications [ Time Frame: 7 days after surgery ] [ Designated as safety issue: Yes ]
We will record whether there are any bleeding complications associated with treatment after surgery.
Same as current
Not Provided
Not Provided
 
Effectiveness of Celecoxib After Surgical Sperm Retrieval
The Use of Celecoxib (Celebrex (c)) in Post-operative Pain Control After Microdissection Testicular Sperm Extraction

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Pain
  • Drug: Celecoxib
    Celecoxib 200mg PO BID x 6 days
    Other Name: Celebrex
  • Drug: Sugar Pill
    Sugar pill PO BID x 6 days
    Other Name: Placebo
  • Experimental: Celecoxib
    Celecoxib will be given for 6 days after surgery
    Intervention: Drug: Celecoxib
  • Placebo Comparator: Sugar pill
    Sugar pill for 6 days after surgery.
    Intervention: Drug: Sugar Pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
78
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01323595
1010011319
No
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Peter N Schlegel, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP