Laparoscopic Cholecystectomy, Pain
Conditions
Keywords
Laparoscopic Cholecystectomy Surgery, Acute Pain, Perioperative Pain
Brief summary
To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.
Interventions
DRUGplacebo
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5
DRUGvaldecoxib
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients had required an elective, non-urgent laparoscopic cholecystectomy, as an outpatient procedure, with ASA Class I-III, with a Baseline Pain Intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS (100 mm) * Patients were able to get their first dose of study medication within 8 hours after the end of surgery
Exclusion criteria
* Patients could not undergo procedures expected to produce a greater degree of surgical trauma than the laparoscopic cholecystectomy alone, nor have acute pre-operative pain (other than biliary colic) nor chronic pain conditions, nor uncontrolled chronic conditions, nor cancer, nor a laboratory abnormality that the investigator considered to contraindicate study participation * Patient had any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures * Patient had a history of known alcohol, analgesic, or narcotic substance abuse within the one year prior to Screening * Patient had any laboratory abnormality at screening, that, in the opinion of the investigator, is not due to the condition requiring surgery and is not expected to resolve post-surgery, and would, therefore, contraindicate study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient's Global Evaluation of Study Medication | Day 2 and Day 3 |
| Summed Pain Intensity (categorical) through 24 hours (SPI 24) | Day 2 and Day 3 |
Secondary
| Measure | Time frame |
|---|---|
| Amount of rescue medication taken | Days 2 to 5 |
| Time between doses of study medication | Days 2 to 5 |
| Worst PI (derived from the mBPI-SF) | Days 2 to 5 |
| Average PI (derived from the mBPI-SF) | Days 2 to 5 |
| Time to first dose of rescue medication | Days 2 to 5 |
| Patient's Global Evaluation of Study Medication | Day 4 and Day 5 |
| SPI 24 (categorical) | Day 4 and Day 5 |
| Time-specific PI (categorical) | Days 2 to 5 |
| SPI 24 (VAS) | Days 2 to 5 |
| Time-specific PI (VAS) | Days 2 to 5 |
| Percent of patients who took rescue medication on each study day | Days 2 to 5 |
Countries
United States
Outcome results
None listed