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
  Purpose

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 Intervention
Pain
Drug: Celecoxib
Drug: Sugar Pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Celecoxib (Celebrex (c)) in Post-operative Pain Control After Microdissection Testicular Sperm Extraction

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Level of pain [ Time Frame: 1 week after surgery ] [ Designated as safety issue: No ]
    Patients will rate their pain for 7 days after surgery.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celecoxib
Celecoxib will be given for 5 days after surgery
Drug: Celecoxib
Celecoxib 200mg PO BID x 6 days
Placebo Comparator: Sugar pill
Sugar pill for 5 days after surgery.
Drug: Sugar Pill
Sugar pill PO BID x 6 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323595

Contacts
Contact: Peggy King, RN 2127465491 pking1@med.cornell.edu

Locations
United States, New York
Department of Urology, Weill Cornell Medical College, Recruiting
New York, New York, United States, 10065
Principal Investigator: Peter N Schlegel, MD         
Sub-Investigator: Wayland Hsiao, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Peter Schlegel, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT01323595     History of Changes
Other Study ID Numbers: 1010011319
Study First Received: March 24, 2011
Last Updated: March 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Pain control
testicular sperm extraction
sperm

Additional relevant MeSH terms:
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 23, 2014