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Trial registered on ANZCTR


Registration number
ACTRN12615000765527
Ethics application status
Not yet submitted
Date submitted
23/06/2015
Date registered
23/07/2015
Date last updated
23/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
For patients with moderate to severe endometriosis undergoing surgical intervention will the use of methadone and bupivacaine compared to fentanyl alone improve the development of post-operative pain and quality of life
Scientific title
Prospective double blind randomised controlled trial of the long-term follow-up of pain post laparoscopic surgery for moderate to severe endometriosis, comparison of standard anaesthesia versus pro-active aggressive intra-operative analgesic intervention, with blinding of surgeon and patient – Pilot Study.
Secondary ID [1] 286961 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 295418 0
Endometriosis 295419 0
Condition category
Condition code
Anaesthesiology 295674 295674 0 0
Pain management
Reproductive Health and Childbirth 295675 295675 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IV methadone 0.2mg/kg (after induction of anaesthesia) and 200mL levobupivocaine 0.625% intraperitoneal (at completion of surgical case)
Intervention code [1] 292166 0
Treatment: Drugs
Comparator / control treatment
IV fentanyl 5mcg/kg (after induction of anaesthesia) + placebo (200ml saline) intraperitoneal (at completion of surgical case)
Control group
Active

Outcomes
Primary outcome [1] 295378 0
VAS pain scores
Timepoint [1] 295378 0
6 months post operatively
Primary outcome [2] 295508 0
QOL scores using SF-12 and EQ-5D Quality of Life Scores
Timepoint [2] 295508 0
6 months post operatively
Secondary outcome [1] 315473 0
VAS pain scores
Timepoint [1] 315473 0
Day 1, 6 weeks, 12 months
Secondary outcome [2] 315728 0
Quality of Life Scores using SF-12 and EQ-5D Scores
Timepoint [2] 315728 0
6 weeks and 12 months post operatively
Secondary outcome [3] 315729 0
Post-operative analgesia requirements - data linkage to medication chart for 24 hours post operative, patient self reported use of regular medications at 6 weeks, 6 months and 12 months.
Timepoint [3] 315729 0
24 hours post-operatively
6 weeks
6 months
12 months
Secondary outcome [4] 315730 0
Post operative sedation using Ramsay sedation score
Timepoint [4] 315730 0
In recovery - assessed at 10 minute intervals post-operatively for thirty minutes
Secondary outcome [5] 315731 0
Post operative nausea & vomiting (anti-emetic use) - data linkage with patient medication chart
Timepoint [5] 315731 0
Day 1
Secondary outcome [6] 315732 0
Discharge time - length of hospital stay assessed from day of surgery until hospital discharge
Timepoint [6] 315732 0
At discharge

Eligibility
Key inclusion criteria
Women aged 18-40 who complain of regular significant dysmenorrhea and / or pelvic pain that has persisted for more than 1 year AND
Who have undergone a staging laparoscopy according to the AFS endometriosis score by a gynaecologist and are documented to have an American Fertility Society Score of 2 or 3. AND
Planned surgery for treatment of endometriosis
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy or sensitivity to methadone or bupivacaine OR
Contraindication to use of opioids OR
Surgical procedure other than laparoscopic treatment of endometriosis, check of tubal patency and minor hysteroscopic procedure OR
Active or relapsing pelvic inflammatory disease OR
Poor communication of written and spoken English for informed consent purposes

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)
Participants will be recruited at the endoscopy clinic at King Edward Memorial Hospital. Consent and information sheets will be provided in the clinic. Patient will undergo formal informed consent when reviewed by the medical staff.
Participants will be randomly allocated to the treatment groups by computer generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation in blocks will be performed at the time of surgery and concealment will be achieved by a sealed envelope technique
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
All patients who undergo randomisation will be included in the analysis. As this is a pilot study, a sample size has not been calculated. All eligible patients will be recruited for a one-year period.

Statistical analysis of the data will be performed with GraphPad (GraphPad Software, San Diego CA). A two sided, paired t test will be used to compare continuous variables. The Fisher’s exact test will be used to analyze proportions. There will not be an interim analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3961 0
King Edward Memorial Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 291516 0
Hospital
Name [1] 291516 0
King Edward Memorial Hospital
Country [1] 291516 0
Australia
Primary sponsor type
Individual
Name
Professor Roger Hart
Address
University of Western Australia
School of Women’s and Infant’s Health
35 Stirling Highway
CRAWLEY, WA, 6009
Country
Australia
Secondary sponsor category [1] 290284 0
None
Name [1] 290284 0
Address [1] 290284 0
Country [1] 290284 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293059 0
WNHS HREC
Ethics committee address [1] 293059 0
Level 1, Children's Clinical
Research Facility (CCRF)
Princess Margaret Hospital
GPO Box D184
Perth WA 6840
Ethics committee country [1] 293059 0
Australia
Date submitted for ethics approval [1] 293059 0
30/06/2015
Approval date [1] 293059 0
Ethics approval number [1] 293059 0

Summary
Brief summary
This is a double blinded prospective randomised trial to investigate the effect of methadone and bupivacaine on the development of chronic pelvic pain in women undergoing surgical management of endometriosis.

Chronic pelvic pain is common in women with endometriosis, and can develop despite surgical treatment of the disease. Endometriosis causes pain in a variety of mechanisms including direct compression/infiltration of nerves by the lesions, inflammation, and damage to pelvic nerves during surgery and may lead to changes in the central nervous system which propagate chronic pain.

The objective of this trial is to prove that active management of intra-operative analgesia with intravenous methadone and intraperitoneal bupivacaine, for women with long-standing pain from moderate to severe endometriosis leads to long-term benefit in terms of pain experience and quality of life.

Patients will be recruited from the endoscopy clinic at King Edward Memorial Hospital. They will be eligible if they have an American Fertility Society Score of 2 or 3 on previous laparoscopy and are planned for laparoscopic treatment on endometriosis.

At recruitment patients will undergo a visual analogue scale (VAS) assessment for pain and will complete a quality of life (QOL) assessment. Patients will be randomised to either the standard analgesia group (IV fentanyl 5mcg/kg + placebo (200ml saline) intraperitoneal) or the intervention group (IV methadone 0.2mg/kg and 200mL levobupivocaine 0.625% intraperitoneal). Repeat pain scores will be recorded on day 1, and repeat pain scores and QOL scores at 6 weeks, 6 months and 12 months post-operatively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58298 0
Prof Roger Hart
Address 58298 0
University of Western Australia
King Edward Memorial Hospital
374 Bagot Road
Subiaco, WA 6008
Country 58298 0
Australia
Phone 58298 0
+61893402222
Fax 58298 0
Email 58298 0
[email protected]
Contact person for public queries
Name 58299 0
Jade Acton
Address 58299 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco, WA 6008
Country 58299 0
Australia
Phone 58299 0
+61893402222
Fax 58299 0
Email 58299 0
[email protected]
Contact person for scientific queries
Name 58300 0
Jade Acton
Address 58300 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco, WA 6008
Country 58300 0
Australia
Phone 58300 0
+61893402222
Fax 58300 0
Email 58300 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

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