Effectiveness of Celecoxib After Surgical Sperm Retrieval

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01323595
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Celecoxib; Drug: Sugar Pill	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Use of Celecoxib (Celebrex (c)) in Post-operative Pain Control After Microdissection Testicular Sperm Extraction
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Celecoxib Celecoxib will be given for 6 days after surgery	Drug: Celecoxib; Celecoxib 200mg PO BID x 6 days; Other Names: Celebrex
Placebo Comparator: Sugar pill Sugar pill for 6 days after surgery.	Drug: Sugar Pill; Sugar pill PO BID x 6 days; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Level of Pain [1 week after surgery]

   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.

Secondary Outcome Measures

1. Number of Participants With Bleeding Complications [7 days after surgery]

   We will record whether there are any bleeding complications associated with treatment after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology, Weill Cornell Medical College,	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Peter N Schlegel, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Study Abstract

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT01323595
• Other Study ID Numbers: 1010011319
• First Posted: Mar 25, 2011
• Last Update Posted: Oct 2, 2018
• Last Verified: Sep 1, 2018

• Keywords provided by Weill Medical College of Cornell University: Pain control; testicular sperm extraction; sperm
• Additional relevant MeSH terms: Celecoxib

Study Results

Participant Flow

Recruitment Details	Patients undergoing testicular sperm extraction surgery
Pre-assignment Detail	No exclusions except allergy to treatment agent (celecoxib)

Arm/Group Title	Celecoxib	Sugar Pill
Arm/Group Description	Celecoxib will be given for 5 days after surgery Celecoxib : Celecoxib 200mg PO BID x 6 days	Sugar pill for 5 days after surgery. Sugar Pill : Sugar pill PO BID x 6 days
Period Title: Overall Study
STARTED	39	39
COMPLETED	16	18
NOT COMPLETED	23	21

Baseline Characteristics

Arm/Group Title	Celecoxib	Sugar Pill	Total
Arm/Group Description	Celecoxib will be given for 6 days after surgery Celecoxib : Celecoxib 200mg PO BID x 6 days	Sugar pill for 6 days after surgery. Sugar Pill : Sugar pill PO BID x 6 days	Total of all reporting groups
Overall Participants	39	39	78
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	39 100%	39 100%	78 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39 (5)	35 (5)	37 (5)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	39 100%	39 100%	78 100%
Region of Enrollment (participants) [Number]
United States	39 100%	39 100%	78 100%

Outcome Measures

1. Primary Outcome

Title	Level of Pain
Description	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.
Time Frame	1 week after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Treatment	Celecoxib
Arm/Group Description	Patients received placebo medication	Patients received celecoxib
Measure Participants	18	16
Mean (Standard Deviation) [Analog pain scale]	6 (2)	4 (2)

2. Secondary Outcome

Title	Number of Participants With Bleeding Complications
Description	We will record whether there are any bleeding complications associated with treatment after surgery.
Time Frame	7 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Celecoxib	Sugar Pill
Arm/Group Description	Celecoxib will be given for 6 days after surgery Celecoxib: Celecoxib 200mg PO BID x 6 days	Sugar pill for 6 days after surgery. Sugar Pill: Sugar pill PO BID x 6 days
Measure Participants	16	18
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	Placebo Treatment		Celecoxib
Arm/Group Description	Patients received placebo medication		Patients received celecoxib
All Cause Mortality
	Placebo Treatment		Celecoxib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo Treatment		Celecoxib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Treatment		Celecoxib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.