Contact information
Type
Scientific
Primary contact
Dr Ian Gilron
ORCID ID
Contact details
Department of Anesthesiology
Victory 2 Pavillion
Kingston General Hospital
76 Stuart Street
Kingston
K7L 2V7
Canada
+1 (0)613 548 7827
gilroni@queensu.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ANAE-152-09
Study information
Scientific title
A double-blind randomised controlled trial of triple versus double non-opioid therapy for post-surgical pain and functional recovery
Acronym
EP-TRIPLE
Study hypothesis
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
Queen's University Research Ethics Board, 02/11/2009
Study design
Double-blind randomised controlled parallel-design four-arm trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Meloxicam, acetaminophen, gabapentin
Primary outcome measures
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 trial start date
01/08/2009
Overall trial end date
31/07/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
144
Participant 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
Recruitment start date
01/08/2009
Recruitment end date
31/07/2012
Locations
Countries of recruitment
Canada
Trial participating centre
Kingston General Hospital
Kingston
K7L 2V7
Canada
Sponsor information
Organisation
Queen's University (Canada)
Sponsor details
Department of Anesthesiology
99 University Avenue
Kingston
K7L 3N6
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Physician's Services Incorporated (PSI) Foundation (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25485880