Combination pharmacotherapy for post-surgical pain and functional recovery

ISRCTN	ISRCTN12723675
DOI	https://doi.org/10.1186/ISRCTN12723675
Protocol serial number	ANAE-152-09
Sponsor	Queen's University (Canada)
Funder	Physician's Services Incorporated (PSI) Foundation (Canada)

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

Department of Anesthesiology
Victory 2 Pavillion
Kingston General Hospital
76 Stuart Street
Kingston
K7L 2V7
Canada

Phone	+1 (0)613 548 7827
Email	gilroni@queensu.ca

Study information

Primary study design	Interventional
Study design	Double-blind randomised controlled parallel-design four-arm trial
Secondary study design	Randomised parallel trial
Study type	Participant 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
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Meloxicam, acetaminophen, gabapentin
Primary outcome measure(s)	Cough-evoked pain intensity, recorded on the day of surgery and post-operative days one and two.
Key secondary outcome measure(s)	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.
Completion date	31/07/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/05/2016: Publication reference added.