Effectiveness of Celecoxib After Surgical Sperm Retrieval
| Status: | Terminated |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/4/2018 |
| Start Date: | January 2011 |
| End Date: | March 2013 |
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.
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.
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.
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.
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
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