Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000217606
Ethics application status
Approved
Date submitted
23/08/2005
Date registered
26/08/2005
Date last updated
26/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective, randomized, double-blind, placebo-controlled trial of multimodal intraoperative analgesia for laparoscopic excision of endometriosis.
Scientific title
A prospective, randomized, double-blind, placebo-controlled trial of the efficacy of multimodal intraoperative analgesia on post-operative pain levels and analgesia requirements on laparoscopic excision of endometriosis.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopic surgery and endometriosis 300 0
Condition category
Condition code
Reproductive Health and Childbirth 341 341 0 0
Other reproductive health and childbirth disorders
Surgery 342 342 0 0
Other surgery
Anaesthesiology 343 343 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multimodal analgesia
(Diclofenac sodium 100mg suppository PR, 0.75% Ropivacaine)
Intervention code [1] 234 0
Treatment: Drugs
Comparator / control treatment
Placebo (Placebo suppository PR, 0.9% Normal Saline)
Control group
Placebo

Outcomes
Primary outcome [1] 397 0
Postoperative pain intensity
Timepoint [1] 397 0
Primary outcome [2] 398 0
Postoperative analgesic requirements
Timepoint [2] 398 0
Secondary outcome [1] 867 0
Side-effects of medications including nausea and vomiting
Timepoint [1] 867 0
Secondary outcome [2] 868 0
Sedation
Timepoint [2] 868 0

Eligibility
Key inclusion criteria
Consent to laparoscopic excision of suspected endometriosis. Capable to complete questions relating to pain, nausea and vomiting.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Failure to give informed consent to participate in trialAllergy or hypersensitivity to amide type local anaestheticsContraindications to use of PR VoltarenPotential for drug interactions with the use of PR VoltarenKnown history of hypersensitivity to paracetamolContraindications to use of morphineSurgical procedure other than laparoscopic excision of endometriosisPregnancyActive or chronic relapsing pelvic inflammatory diseaseSuspected gynaecological malignancyCurrently on prescribed Codeine and/or prescribed OpiatesPlanned laparoscopic hysterectomyPoor comprehension of written and spoken English.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
166
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 403 0
Commercial sector/Industry
Name [1] 403 0
AGES Research Grant
Country [1] 403 0
Primary sponsor type
Individual
Name
Michael Costello
Address
Country
Secondary sponsor category [1] 326 0
None
Name [1] 326 0
Nil
Address [1] 326 0
Country [1] 326 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35660 0
Address 35660 0
Country 35660 0
Phone 35660 0
Fax 35660 0
Email 35660 0
Contact person for public queries
Name 9423 0
Michael Costello
Address 9423 0
Royal Hospital for Women
Barker St
Randwick NSW 2031
Country 9423 0
Australia
Phone 9423 0
02-93826677
Fax 9423 0
Email 9423 0
[email protected]
Contact person for scientific queries
Name 351 0
Michael Costello
Address 351 0
Royal Hospital for Women
Barker St
Randwick NSW 2031
Country 351 0
Australia
Phone 351 0
02-93826677
Fax 351 0
Email 351 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.