Analgesic drug combinations in post-operative movement-evoked pain
| ISRCTN | ISRCTN33126288 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33126288 |
| Secondary identifying numbers | ANAE-099-03 |
- Submission date
- 21/04/2006
- Registration date
- 30/05/2006
- Last edited
- 27/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ian Gilron
Scientific
Scientific
Victory 2 Pavillion
Kingston General Hospital Anesthesiology
76 Stuart Street
Kingston
Ontario
K7L 2V7
Canada
| Phone | +1 613 548 7827 |
|---|---|
| gilroni@post.queensu.ca |
Study information
| Study design | Double-blind randomised parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The central hypothesis of this application is that a combination of the COX-2I, meloxicam, and the 3-alkylated gamma-amino butyric acid (GABA) analog, gabapentin, will reduce evoked pain and opioid consumption to a greater degree than either drug alone. It is also postulated that superior reduction of evoked pain will result in enhancement of post-operative physiological recovery. The central hypothesis will be tested and the objective of the trial accomplished by pursuing the following specific objective: To evaluate the efficacy of reducing evoked post-operative pain, and improving post-operative pulmonary performance, by: 1. The COX-2 inhibitor non-steroidal anti-inflamatory drug (NSAID) meloxicam 2. The 3-alkylated gamma-amino butyric acid (GABA) analog gabapentin, or 3. A combination of meloxicam and gabapentin |
| Ethics approval(s) | Queen's University Research Ethics Board approved in June 2004 |
| Health condition(s) or problem(s) studied | Post-operative pain |
| Intervention | 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. Gabapentin 1200 to 1600 mg per day 3. A combination of meloxicam 15 mg per day and gabapentin 1200 to 1600 mg per day |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gabapentin, meloxicam |
| Primary outcome measure | Cough-evoked pain intensity |
| Secondary outcome measures | 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) |
| Overall study start date | 09/11/2004 |
| Completion date | 30/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 96 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 09/11/2004 |
| Date of final enrolment | 30/12/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Victory 2 Pavillion
Ontario
K7L 2V7
Canada
K7L 2V7
Canada
Sponsor information
Physician's Services Incorporated (PSI) Foundation (Canada)
Charity
Charity
5160 Yonge Street
Suite 1006
Toronto
Ontario
M2N 6L9
Canada
| Phone | +1 416 226 6323 |
|---|---|
| psif@psifoundation.org | |
| Website | http://www.psifoundation.org |
"ROR" |
https://ror.org/0385yzn06 |
Funders
Funder type
Charity
Physician's Services Incorporated (PSI) Foundation (Canada) (ref: 03-30)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2009 | Yes | No |
