Effectiveness of Celecoxib After Surgical Sperm Retrieval

NCT01323595 | Terminated Results

• 1 other identifier: 1010011319
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Pain control; testicular sperm extraction; sperm

Outcome Measures

Primary Outcomes (1)

• Level of Pain

  Patients will rate their pain for 7 days after surgery using an 11-point visual analog scale, ranging from 0 to 10, in which 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.

  1 week after surgery

Secondary Outcomes (1)

• Number of Participants With Bleeding Complications

  7 days after surgery

Study Arms (2)

Celecoxib

EXPERIMENTAL

Celecoxib will be given for 6 days after surgery

Drug: Celecoxib

Sugar pill

PLACEBO COMPARATOR

Sugar pill for 6 days after surgery.

Drug: Sugar Pill

Interventions

Celecoxib DRUG

Celecoxib 200mg PO BID x 6 days

Also known as: Celebrex

Celecoxib

Sugar Pill DRUG

Sugar pill PO BID x 6 days

Also known as: Placebo

Sugar pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>/= 18 years old
• Male
• Scheduled to undergo microdissection testicular sperm extraction

You may not qualify if:

• History of allergies to celecoxib (Celecoxib)
• Renal failure
• History of ulcer disease
• Any history of myocardial infarction
• Any history of stroke
• History of bleeding diathesis
• Use of aspirin

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Department of Urology, Weill Cornell Medical College,

New York, New York, 10065, United States

Location

Related Links

• Study Abstract

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Celecoxib; Sugars

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Chairman, Department of Urology
• Organization: Weill Cornell Medical College

pnschleg@med.cornell.edu

212 746-5491

Study Officials

• Peter N Schlegel, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 25, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: October 2, 2018
• Results First Posted: July 11, 2014

Record last verified: 2018-09

Locations

US (1)