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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
28/10/2021
Date data sharing statement initially provided
28/10/2021
Date results information initially provided
28/10/2021
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?
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Scientific title
The effect of pregabalin and celecoxib on the analgesic requirements after laparoscopic cholecystectomy
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Secondary ID [1]
280346
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NIL
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Universal Trial Number (UTN)
U1111-1130-0146
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
pain after laparoscopic cholecystectomy
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Condition category
Condition code
Anaesthesiology
286548
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0
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Pain management
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Oral and Gastrointestinal
286568
286568
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
284701
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Treatment: Drugs
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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.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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1,2,4,8,12,24 hours postoperatively,
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Secondary outcome [1]
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assessment of preoperative anxiety with the verbal rating scale 0-10.
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Assessment method [1]
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Timepoint [1]
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once before premedication and once before induction
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Secondary outcome [2]
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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
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Assessment method [2]
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Timepoint [2]
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1,2,4,8,12,24 hours postoperatively
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Secondary outcome [3]
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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
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Assessment method [3]
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Timepoint [3]
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1,2,4,8,12,24 hours postoperatively
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Secondary outcome [4]
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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.
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Assessment method [4]
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Timepoint [4]
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At 1,2,4,8,12,24 hours postoperatively
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Secondary outcome [5]
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satisfaction with pain relief by scale of 0-10, 0, completely dissatisfied; 10- completely satisfied
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Assessment method [5]
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Timepoint [5]
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assessed at 24 hours postoperatively
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Eligibility
Key inclusion criteria
ASA I/II patients, 18-70 years, undergoing laparoscopic cholecystectomy with minimal or no health issues.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Factorial
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Other design features
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Phase
Phase 3 / Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
15/05/2012
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Actual
13/07/2012
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Date of last participant enrolment
Anticipated
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Actual
15/07/2014
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Date of last data collection
Anticipated
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Actual
27/02/2015
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Sample size
Target
100
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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The Prince Charles Hospital - Chermside
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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The Prince Charles Hospital foundation
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Address [1]
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Rode Road, Chermside, Queensland- 4032
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Usha Gurunathan
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Address
Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, Brisbane, QLD-4032
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Dr.Usha Gurunathan
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Address
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The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
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Country
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Australia
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Phone
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+61 7 3139 4000
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Dr.Usha Gurunathan
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Address
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The Prince Charles Hospital, Rode Road, Chermside, QLD-4032
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Country
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Australia
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Phone
17316
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+61 7 3139 4000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Dr.Usha Gurunathan
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Address
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The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
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Country
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Australia
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Phone
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+61 7 3139 4000
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Fax
8244
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Gurunathan et al. The effect of pregabalin and cel...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
The effect of pregabalin and celecoxib on the analgesic requirements after laparoscopic cholecystectomy: a randomized controlled trial.
2016
https://dx.doi.org/10.1007/s00540-015-2078-9
N.B. These documents automatically identified may not have been verified by the study sponsor.
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