Effectiveness of Celecoxib After Surgical Sperm Retrieval

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01323595
First received: March 24, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 24, 2011
March 24, 2011
January 2011
November 2011   (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.
Same as current
No Changes Posted
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.

Not Provided
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
  • Drug: Sugar Pill
    Sugar pill PO BID x 6 days
  • Experimental: Celecoxib
    Celecoxib will be given for 5 days after surgery
    Intervention: Drug: Celecoxib
  • Placebo Comparator: Sugar pill
    Sugar pill for 5 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.
 
Recruiting
120
Not Provided
November 2011   (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: Peggy King, RN 2127465491 pking1@med.cornell.edu
United States
 
NCT01323595
1010011319
No
Peter Schlegel, MD, Weill Cornell Medical College
Weill Medical College of Cornell University
Not Provided
Not Provided
Weill Medical College of Cornell University
March 2011

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