Post-operative pain Surgery Post-operative pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 or older (either sex) requiring elective laparoscopic cholecystectomy 2. American Society of Anesthesiologists class 1 or 2 3. Body mass index (weight in kilograms/[height in meters]^2) less than or equal to 35
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity to any agents to be used in the study 2. History of serious organ disease/dysfunction 3. History of persistent pain (excluding gallbladder pain) prior to surgery 4. Daily intake, or intake within 48 hours prior to surgery, of any glucocorticoid agents, non-steroidal anti-inflammatory agents, or other analgesics, not including daily administration of less than or equal to 325 mg of aspirin for cardiovascular prophylaxis 5. History or evidence of substance or alcohol abuse 6. History of a major psychiatric disorder 7. History of a bleeding disorder 8. History of peptic ulcer disease 9. History of moderate to severe asthma with forced expiratory volume in 1 second (FEV1) less than 65% predicted 10. History of a seizure disorder requiring treatment with an anticonvulsant drug 11. A language barrier in communicating with research staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cough-evoked pain intensity | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain intensity at rest, while sitting, and at peak expiration 2. Peak expiratory flow rate, forced vital capacity, forced expiratory volume over 1 second 3. Total analgesic consumption (fentanyl on day of surgery, morphine equivalents on postoperative days 1 and 2) 4. Side effects, blinding questionnaire responses 5. Time to discharge from hospital, time to return to work (in those working outside of the home) | — |
Countries
Canada