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Trial registered on ANZCTR


Registration number
ACTRN12608000471381
Ethics application status
Approved
Date submitted
1/09/2008
Date registered
22/09/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Gabapentin reduce the incidence of chronic pain post thoracotomy?
Scientific title
A randomised, double blinded, controlled trial of standard analgesia + Gabapentin versus standard analgesia + placebo for post thoracotomy analgesia to determine the impact of gabapentin on post thoracotomy pain at 3 months.
Secondary ID [1] 704 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of a chronic pain syndrome developing post thoracotomy. 3630 0
Condition category
Condition code
Anaesthesiology 3795 3795 0 0
Anaesthetics
Other 3796 3796 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants who have been randomised to receive Gabapentin will receive 1,200 mg of gabapentin orally as a single dose one hour before surgery. Day one post operatively or when the patient is able to tolerate diet, they will receive 300mg of Gabapentin eight hourly orally. This regime will continue for three weeks. They will also receive whatever analgesic regime is determined appropriate by the treating anaesthetist.
Intervention code [1] 3342 0
Treatment: Drugs
Intervention code [2] 3343 0
Prevention
Comparator / control treatment
The participants randomised to receive placebo will receive 4 microcrystalline cellulose capsules (sugar capsules) orally as a pre-med one hour before their operation. Day one post operatively or when the patient is able to tolerate diet, they will receive one capsule orally eight hourly for three weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 4690 0
To determine the impact of Gabapentin on post thoracotomy pain at three months we will invite the participants to attend an out patient appointment at the Pain Management Clinic. Primary outcomes will be measured by the participant's activities, the presence or absence of persistant pain, length of rehabilitation (either in an approved centre or with relatives), if they have achieved unrestricted daily living activities and the date that they have returned to work. A 15 item short form McGill Questionnaire will be completed and measurements of punctuate hyperalgesia around the thoracotomy incision with a von Frey device will also take place at this final assessment.
Timepoint [1] 4690 0
Baseline, three weeks and three months post operatively.
Secondary outcome [1] 7910 0
To examine the impact of Gabapentin on acute pain post operatively the participanrs will be followed up for the first three days by the Acute Pain Management Team who will record the best and worst pain score per twenty four hours for days 1 to 3. The participants will be instructed to use the numerical rating scale (0= no pain, 10= worst pain imaginable) to indicate the level of pain that they may/may not be experiencing. The participant's charts will also be assessed and analgesic requirements will be recorded. Additionally a four point categorical system/ side effect score relating to sedation, nausea, vomiting, itch and hallucination will also be used.
Timepoint [1] 7910 0
Immediately post operatively to day three post operatively.
Secondary outcome [2] 7911 0
To examine the recovery of patients undergoing thoracotomy using Gabapentin for analgesia we will use a 15 item short form McGill Pain questionnaire on discharge. At this time a mechanical punctuate von frey device will be used to measure punctuate hyperalgesia around the thoracotomy incision. The particpant will be contacted at three weeks post operatively by telephone to assess for any complications. Reports on mobilisation and the ease at which this is accomplished will also be recorded.
Adverse side effects will also be recorded and the severity noted.
Timepoint [2] 7911 0
Discharge from hospital, three weeks and three months.

Eligibility
Key inclusion criteria
Patients undergoing open thoracic surgery who are 18 years old or older and have an anticipated post operative stay of greater than twenty four hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have a known hyper sensitvity to Gabapentin. Women who are pregnant or breast feeding. Patients who are currently using Gabapentin. Patients who have chronic renal insufficiency (pre-operative creatinine level> 200 umol/L or are receiving dialysis. Patients with a history of chronic pain syndrome. patients currently using Cimetidine or regular antacids or have a history of epilepsy or seizures. Patients with a history of alcoholism or recreational drug use.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will take place on day of surgery in the Pharmacy department utilising pre-prepared closed envelopes, ensuring blinding.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3878 0
Self funded/Unfunded
Name [1] 3878 0
Country [1] 3878 0
Primary sponsor type
Individual
Name
Dr John Monagle
Address
Anaesthetic Department
Level 3 Monash Medical Centre
246 Clayton Road
Clayton, Victoria, 3168
Country
Australia
Secondary sponsor category [1] 3482 0
Hospital
Name [1] 3482 0
Monash Medical Centre, Southern Health
Address [1] 3482 0
246 Clayton Road
Clayton. Victoria. 3168
Country [1] 3482 0
Australia
Other collaborator category [1] 393 0
Individual
Name [1] 393 0
Marie Backstrom
Address [1] 393 0
Research Co-ordinator, Anaesthetic Department, Level 3, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
Country [1] 393 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5866 0
Southern Health Human Research Committee A
Ethics committee address [1] 5866 0
Level 4 Main Block, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
Ethics committee country [1] 5866 0
Australia
Date submitted for ethics approval [1] 5866 0
Approval date [1] 5866 0
21/07/2008
Ethics approval number [1] 5866 0
08081A

Summary
Brief summary
Patients undergoing surgery usually experience some sort of pain post operatively. There are many drugs which can be taken to reduce or take away the pain. There are also different types of Anaesthetic procedures to help a patient who is in pain (such as an epidural for pain relief in childbirth).
There have been recent advances in medicine which show that using several different types of pain medication is more effective used together and has fewer side effects such as nausea and vomiting, constipation and drowsiness. Also at this time, there is a theory that receiving pain relief just before an operation can help reduce the pain afterwards.
Unfortunately for some patients the pain can be hard to control and it may bother them for some time (months or years) after the operation. We call this chronic pain and it is a common and difficult problem to manage.
Previous experience has shown that using various pain medications is a useful approach to treating pain as there are many factors that can cause pain. It makes sense to use different medications to target the different pain pathways which are aggravated after surgery.
Some pain relieving drugs have been found to have some unacceptable side effects. It has reduced the choice of medication that we can use to treat pain. We are proposing to use a drug that is commonly used for the treatment of chronic pain, Gabapentin. Gabapentin was first used for the treatment of seizures but it was quickly found to be useful in treating chronic pain. Gabapentin is licensed in Australia for treating pain and seizures. There have been some studies recently that have shown that it is helpful in treating immediate post operative pain (acute pain). As well as studying the effects of Gabapentin on post operative pain, we would also like to investigate whether continuing Gabapentin for 3 weeks after a thoracotomy helps prevent or reduces chronic pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28891 0
Address 28891 0
Country 28891 0
Phone 28891 0
Fax 28891 0
Email 28891 0
Contact person for public queries
Name 12048 0
Marie Backstrom
Address 12048 0
Anaesthetic Department, Level 3, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
Country 12048 0
Australia
Phone 12048 0
03 95943280
Fax 12048 0
03 95946290
Email 12048 0
[email protected]
Contact person for scientific queries
Name 2976 0
Dr John Monagle
Address 2976 0
Anaesthetic Department, Level 3, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
Country 2976 0
Australia
Phone 2976 0
03 95943283
Fax 2976 0
03 95946290
Email 2976 0
[email protected]

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