Condition category
Surgery
Date applied
21/04/2006
Date assigned
30/05/2006
Last edited
27/01/2009
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

Victory 2 Pavillion
Kingston General Hospital Anesthesiology
76 Stuart Street
Kingston
Ontario
K7L 2V7
Canada
+1 613 548 7827
gilroni@post.queensu.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ANAE-099-03

Study information

Scientific title

Acronym

Study hypothesis

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

Queen's University Research Ethics Board approved in June 2004

Study design

Double-blind randomised parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Gabapentin, meloxicam

Primary outcome measures

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 trial start date

09/11/2004

Overall trial end date

30/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

96

Participant 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

Recruitment start date

09/11/2004

Recruitment end date

30/12/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Victory 2 Pavillion
Ontario
K7L 2V7
Canada

Sponsor information

Organisation

Physician's Services Incorporated (PSI) Foundation (Canada)

Sponsor details

5160 Yonge Street
Suite 1006
Toronto
Ontario
M2N 6L9
Canada
+1 416 226 6323
psif@psifoundation.org

Sponsor type

Charity

Website

http://www.psifoundation.org

Funders

Funder type

Charity

Funder name

Physician's Services Incorporated (PSI) Foundation (Canada) (ref: 03-30)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19151299

Publication citations

  1. Results

    Gilron I, Orr E, Tu D, Mercer CD, Bond D, A randomized, double-blind, controlled trial of perioperative administration of gabapentin, meloxicam and their combination for spontaneous and movement-evoked pain after ambulatory laparoscopic cholecystectomy., Anesth. Analg., 2009, 108, 2, 623-630, doi: 10.1213/ane.0b013e318193cd1b.

Additional files

Editorial Notes