Pain
Conditions
Keywords
Pain control, testicular sperm extraction, sperm
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.
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.
Interventions
DRUGCelecoxib
Celecoxib 200mg PO BID x 6 days
DRUGSugar Pill
Sugar pill PO BID x 6 days
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Bleeding Complications | 7 days after surgery | We will record whether there are any bleeding complications associated with treatment after surgery. |
Countries
United States
Participant flow
Recruitment details
Patients undergoing testicular sperm extraction surgery
Pre-assignment details
No exclusions except allergy to treatment agent (celecoxib)
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib Celecoxib will be given for 6 days after surgery
Celecoxib : Celecoxib 200mg PO BID x 6 days | 39 |
| Sugar Pill Sugar pill for 6 days after surgery.
Sugar Pill : Sugar pill PO BID x 6 days | 39 |
| Total | 78 |
Baseline characteristics
| Characteristic | Sugar Pill | Celecoxib | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 39 Participants | 78 Participants |
| Age, Continuous | 35 years STANDARD_DEVIATION 5 | 39 years STANDARD_DEVIATION 5 | 37 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 39 participants | 39 participants | 78 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 39 Participants | 39 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 |
Outcome results
Primary
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.
Time frame: 1 week after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Treatment | Level of Pain | 6 Analog pain scale | Standard Deviation 2 |
| Celecoxib | Level of Pain | 4 Analog pain scale | Standard Deviation 2 |
Secondary
Number of Participants With Bleeding Complications
We will record whether there are any bleeding complications associated with treatment after surgery.
Time frame: 7 days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Treatment | Number of Participants With Bleeding Complications | 0 Participants |
| Celecoxib | Number of Participants With Bleeding Complications | 0 Participants |