Combination pharmacotherapy for post-surgical pain and functional recovery
| ISRCTN | ISRCTN12723675 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12723675 |
| Secondary identifying numbers | ANAE-152-09 |
- Submission date
- 29/07/2009
- Registration date
- 28/10/2009
- Last edited
- 19/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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
Department of Anesthesiology
Victory 2 Pavillion
Kingston General Hospital
76 Stuart Street
Kingston
K7L 2V7
Canada
| Phone | +1 (0)613 548 7827 |
|---|---|
| gilroni@queensu.ca |
Study information
| Study design | Double-blind randomised controlled parallel-design four-arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A double-blind randomised controlled trial of triple versus double non-opioid therapy for post-surgical pain and functional recovery |
| Study acronym | EP-TRIPLE |
| Study objectives | A triple combination of non-opioid drugs (i.e. acetaminophen, meloxicam and gabapentin) will reduce post-surgical evoked pain to a greater degree than any of the three respective double-drug combinations (i.e. meloxicam, acetaminophen and gabapentin is superior to meloxicam and acetaminophen, meloxicam and gabapentin and acetaminophen and gabapentin). |
| Ethics approval(s) | Queen's University Research Ethics Board, 02/11/2009 |
| Health condition(s) or problem(s) studied | Post-surgical pain following abdominal hysterectomy |
| Intervention | Enrolled patients will be randomised, in a double-blind fashion, to receive oral administration of one of four possible treatments: 1. Meloxicam 15 mg/day and acetaminophen 4000 mg/day and gabapentin 1800 mg/day 2. Meloxicam 15 mg/day and acetaminophen 4000 mg/day 3. Meloxicam 15 mg/day and gabapentin 1800 mg/day 4. Acetaminophen 4000 mg/day and gabapentin 1800 mg/day Total duration of treatment is from one hour before surgery to 48 hours after surgery. Total duration of follow-up is 30 days following surgery for all trial arms. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Meloxicam, acetaminophen, gabapentin |
| Primary outcome measure | Cough-evoked pain intensity, recorded on the day of surgery and post-operative days one and two. |
| Secondary outcome measures | 1. Pain intensity at rest, during sitting, and with forced expiration 2. Retrospective measure of average nocturnal pain intensity from 10 pm (previous day) to 8 am (current morning) recorded at 8 am on post-operative days 1 and 2 3. Peak expiratory flow rate, forced vital capacity, forced expiratory volume over one second 4. Total opioid consumption (fentanyl on day of surgery, morphine [nurse-administered and patient-controlled] on day of surgery and post-operative days 1 and 2) 5. Time to fulfilment of post-anaesthetic care unit discharge criteria 6. Presence and severity (mild, moderate or severe) of 12 opioid-related symptoms (evaluated by open-ended questioning): nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating, drowsiness or difficulty staying awake, feeling light-headed or dizzy, feeling confused, feelings of general fatigue or weakness, itchiness, dry mouth, and headache 7. Other side effects and their severity (mild, moderate or severe) 8. Time to bladder extubation; time to first urination after bladder catheter removal; time to first bowel movement 9. Timed 'up and go' test 10. Blinding questionnaires 11. Modified Brief Pain Inventory 12. Time to discharge from hospital, time to return to regular activities and return to work (in those working outside of the home) 13. 30-day post-operative surgical pain intensity (present rest pain, present cough pain and worst pain in past week) Recorded on the day of surgery and post-operative days one and two. On post-operative day 30, only pain and major adverse events will be recorded. |
| Overall study start date | 01/08/2009 |
| Completion date | 31/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 144 |
| Key inclusion criteria | 1. Female patients aged 18 or older requiring elective abdominal hysterectomy 2. American Society of Anaesthesiologists class 1 or 2 3. Body mass index less than or equal to 35 kg/m^2 |
| Key exclusion criteria | 1. Hypersensitivity to any study drugs 2. Serious organ disease/dysfunction 3. Persistent pre-operative pain 4. Daily intake, or intake 48 hours pre-operatively, of any analgesic 5. Alcohol/substance abuse 6. A major psychiatric disorder 7. A bleeding disorder 8. Peptic ulcer disease 9. Asthma/chronic obstructive pulmonary disease (COPD) 10. A seizure disorder 11. Any language barrier to communicating with research staff 12. Aged over 80 years |
| Date of first enrolment | 01/08/2009 |
| Date of final enrolment | 31/07/2012 |
Locations
Countries of recruitment
- Canada
Study participating centre
Kingston General Hospital
Kingston
K7L 2V7
Canada
K7L 2V7
Canada
Sponsor information
Queen's University (Canada)
University/education
University/education
Department of Anesthesiology
99 University Avenue
Kingston
K7L 3N6
Canada
| Website | http://www.queensu.ca/ |
|---|---|
"ROR" |
https://ror.org/02y72wh86 |
Funders
Funder type
Research organisation
Physician's Services Incorporated (PSI) Foundation (Canada)
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 | 01/04/2015 | Yes | No |
Editorial Notes
19/05/2016: Publication reference added.
