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Trial registered on ANZCTR


Registration number
ACTRN12612000447853
Ethics application status
Approved
Date submitted
16/04/2012
Date registered
19/04/2012
Date last updated
23/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
How effective are the drugs pregabalin and celecoxib in relieving pain after laparoscopic gall bladder surgery?
Scientific title
The effect of pregabalin and celecoxib on the analgesic requirements after laparoscopic cholecystectomy
Secondary ID [1] 280346 0
NIL
Universal Trial Number (UTN)
U1111-1130-0146
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain after laparoscopic cholecystectomy 286302 0
Condition category
Condition code
Anaesthesiology 286548 286548 0 0
Pain management
Oral and Gastrointestinal 286568 286568 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
premedication 1 hour before the surgery with

Group pregabalin: pregabalin 150 mg + matched celecoxib placebo orally

Group celecoxib: celecoxib 400 mg + pregabalin placebo orally

Group pregabalin/celecoxib: pregabalin 150 mg + celecoxib 400 mg orally

Group placebo: pregabalin placebo + celecoxib placebo orally

Matched celecoxib and pregabalin placebos are identical in shape, size and colour to celecoxib and pregabalin tablets, but they differ from the original tablets in that they contain no active ingredients.
12 hours after the premedication, second dose of study drugs (pregabalin 150 mg/ celecoxib 200 mg/ combination/ placebo) given.
Intervention code [1] 284701 0
Treatment: Drugs
Comparator / control treatment
Matched celecoxib and pregabalin placebos are identical in shape, size and colour to celecoxib and pregabalin tablets, but they differ from the original tablets in that they contain no active ingredients. All the groups do get patient controlled analgesia with fentanyl as the routine care.
Control group
Placebo

Outcomes
Primary outcome [1] 286976 0
postoperative pain and PCA fentanyl requirements are assessed. Assessment of pain at rest & with movement with verbal rating scale 0-10 with 0 representing no pain and 10 the worst imaginable pain
Timepoint [1] 286976 0
1,2,4,8,12,24 hours postoperatively,
Secondary outcome [1] 297093 0
assessment of preoperative anxiety with the verbal rating scale 0-10.
Timepoint [1] 297093 0
once before premedication and once before induction
Secondary outcome [2] 297094 0
sedation scores as assessed by 4 point ordinal scale
0- none ,completely awake
1- mild, occasional drowsy, easy to rouse
2- moderate, arousable, but not able to stay awake
3- severe, difficult to rouse or unarousable
Timepoint [2] 297094 0
1,2,4,8,12,24 hours postoperatively
Secondary outcome [3] 297166 0
Nausea & vomiting assessed with the 4 point ordinal scale

0- no N +V
1- mild N+V
2- moderate N+V
3- severe N+V
Timepoint [3] 297166 0
1,2,4,8,12,24 hours postoperatively
Secondary outcome [4] 297167 0
Other side effects-headache/light headedness/dizziness/visual disturbance- diplopia/pruritus/difficulty in walking or concentrating/drowsiness & difficulty in staying awake/itchiness/drymouth/confusion. The above side effects are noted with yes/no ordinal scale.
Timepoint [4] 297167 0
At 1,2,4,8,12,24 hours postoperatively
Secondary outcome [5] 297168 0
satisfaction with pain relief by scale of 0-10, 0, completely dissatisfied; 10- completely satisfied
Timepoint [5] 297168 0
assessed at 24 hours postoperatively

Eligibility
Key inclusion criteria
ASA I/II patients, 18-70 years, undergoing laparoscopic cholecystectomy with minimal or no health issues.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. patients with significantly established IHD( angina, MI, heart failure) /peripheral arterial disease/cerebrovascular disease, patients with NYHA II-IV functional capacity classification of heart failure, uncontrolled DM, Hypertension.
2. ASA>2
3. patients with dizziness
4. history of peptic ulcer
5. pregnancy or lactation
6. patients on anticonvulsants, antidepressants
7. impaired kidney, liver function
8. obese( patients> BMI 40)
9. psychiatric disorders, drug/alcohol abuse
10. history of aspirin sensitive asthma, known hypersensitivity to celecoxib or sulphonamides, history of allergic-type reactions after aspirin or NSAIDs.
11. history of epilepsy
12. patients receiving analgesics/sedatives ( opioids incl. tramadol, acetaminophen, NSAIDs) within 24 hours preoperatively
13.Conversion to open cholecystectomy, bile spillage, insertion of drain.

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)
A randomisation list will be created by our hospital pharmacy using a computer program. Patients who meet the inclusion/exclusion criteria, and give informed consent, would be randomly allocated to four groups based on computer generated codes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 403 0
The Prince Charles Hospital - Chermside

Funding & Sponsors
Funding source category [1] 285118 0
Charities/Societies/Foundations
Name [1] 285118 0
The Prince Charles Hospital foundation
Address [1] 285118 0
Rode Road, Chermside, Queensland- 4032
Country [1] 285118 0
Australia
Primary sponsor type
Individual
Name
Usha Gurunathan
Address
Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, Brisbane, QLD-4032
Country
Australia
Secondary sponsor category [1] 283976 0
None
Name [1] 283976 0
Address [1] 283976 0
Country [1] 283976 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Pain is inadequately treated in many of the surgical procedures. Postoperative pain is the main reason for the prolonged convalescence after laparoscopic (key hole) gall bladder surgery. Severe postoperative pain after gall bladder surgery can cause significant long standing pain, if not adequately treated initially.

Postoperative pain has been traditionally treated with opioids, non steroidal anti-inflammatory agents and paracetamol. Opioids are associated with significant side effects and constant search for an alternative agent with similar potency and minimal side effects has been on for a very long time.

Pregabalin and Gabapentin have recently elicited a lot of interest as being useful drugs for postoperative pain relief. Pregabalin has got a lot of pharmacokinetic advantages over Gabapentin as being more potent and more bioavailable with very minimal side effects. When combined with drugs like celecoxib, which are the
safer versions of anti-inflammatory drugs as of current evidence, Pregabalin is likely to exhibit synergistic
effect. This project evaluates the efficacy of Pregabalin, Celecoxib and their combination to treat postoperative pain in patients undergoing laparoscopic gall bladder surgery.

This will be a randomized, double blind study. Selected participants will be given pregabalin, celecoxib or their combination or their placebo before and after surgery. They will be given standard general anaesthesia according to protocol. Their pain scores after surgery, demand for pain killers, anxiety levels, satisfaction with pain relief and other side effects will be recorded by a nurse.

Statistical analysis will be made with the above observations to evaluate the efficacy of the study drugs.

If this research yields positive result, it can add on to the evidence for using a different group of drugs for relief of acute postoperative pain as opposed to conventional pain relief with opioids. Also, the same group of drugs may be trialled in future for minimising the occurrence of chronic pain after surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34069 0
Address 34069 0
Country 34069 0
Phone 34069 0
Fax 34069 0
Email 34069 0
Contact person for public queries
Name 17316 0
Dr.Usha Gurunathan
Address 17316 0
The Prince Charles Hospital, Rode Road, Chermside, QLD-4032
Country 17316 0
Australia
Phone 17316 0
+61 7 3139 4000
Fax 17316 0
Email 17316 0
usha_gurunathan@health.qld.gov.au
Contact person for scientific queries
Name 8244 0
Dr.Usha Gurunathan
Address 8244 0
The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Country 8244 0
Australia
Phone 8244 0
+61 7 3139 4000
Fax 8244 0
Email 8244 0
usha_gurunathan@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results