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Analgesic drug combinations in post-operative movement-evoked pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33126288
Enrollment
96
Registered
2006-05-30
Start date
2004-11-09
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative pain Surgery Post-operative pain

Interventions

Enrolled patients will be randomised, in a double-blind fashion, to receive oral administration of one of three possible treatments (n = 32 patients per group): 1. Meloxicam 15 mg per day 2. Gabapenti

Sponsors

Physician's Services Incorporated (PSI) Foundation (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Cough-evoked pain intensity

Secondary

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026