Condition category
Signs and Symptoms
Date applied
29/07/2009
Date assigned
28/10/2009
Last edited
19/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.queensu.ca/

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

Publication citations

Additional files

Editorial Notes

19/05/2016: Publication reference added.