ANZCTR - Registration

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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 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?

Scientific title

The effect of pregabalin and celecoxib on the analgesic requirements after laparoscopic cholecystectomy

Secondary ID [1]

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

Condition category

Condition code

Anaesthesiology

Pain management

Oral and Gastrointestinal

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]

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]

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]

1,2,4,8,12,24 hours postoperatively,

Secondary outcome [1]

assessment of preoperative anxiety with the verbal rating scale 0-10.

Timepoint [1]

once before premedication and once before induction

Secondary outcome [2]

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]

1,2,4,8,12,24 hours postoperatively

Secondary outcome [3]

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]

1,2,4,8,12,24 hours postoperatively

Secondary outcome [4]

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]

At 1,2,4,8,12,24 hours postoperatively

Secondary outcome [5]

satisfaction with pain relief by scale of 0-10, 0, completely dissatisfied; 10- completely satisfied

Timepoint [5]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

15/05/2012

Actual

13/07/2012

Date of last participant enrolment

Anticipated

Actual

15/07/2014

Date of last data collection

Anticipated

Actual

27/02/2015

Sample size

Target

100

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Prince Charles Hospital - Chermside

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Prince Charles Hospital foundation

Address [1]

Rode Road, Chermside, Queensland- 4032

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

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

Dr Dr.Usha Gurunathan

Address

The Prince Charles Hospital, Rode Road, Chermside, QLD 4032

Country

Australia

Phone

+61 7 3139 4000

Fax

usha.gurunathan@health.qld.gov.au

Contact person for public queries

Name

Dr.Usha Gurunathan

Address

The Prince Charles Hospital, Rode Road, Chermside, QLD-4032

Country

Australia

Phone

+61 7 3139 4000

Fax

usha_gurunathan@health.qld.gov.au

Contact person for scientific queries

Name

Dr.Usha Gurunathan

Address

The Prince Charles Hospital, Rode Road, Chermside, QLD 4032

Country

Australia

Phone

+61 7 3139 4000

Fax

usha_gurunathan@health.qld.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

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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Documents added manually

Documents added automatically