Effectiveness of Celecoxib After Surgical Sperm Retrieval
Recruitment status was Recruiting
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.
|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|
- Level of pain [ Time Frame: 1 week after surgery ] [ Designated as safety issue: No ]Patients will rate their pain for 7 days after surgery.
- 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.
|Study Start Date:||January 2011|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Celecoxib will be given for 5 days after surgery
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
|Contact: Peggy King, RNemail@example.com|
|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|