ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Pain

Endometriosis

Condition category

Condition code

Anaesthesiology

Pain management

Reproductive Health and Childbirth

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]

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]

VAS pain scores

Timepoint [1]

6 months post operatively

Primary outcome [2]

QOL scores using SF-12 and EQ-5D Quality of Life Scores

Timepoint [2]

6 months post operatively

Secondary outcome [1]

VAS pain scores

Timepoint [1]

Day 1, 6 weeks, 12 months

Secondary outcome [2]

Quality of Life Scores using SF-12 and EQ-5D Scores

Timepoint [2]

6 weeks and 12 months post operatively

Secondary outcome [3]

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]

24 hours post-operatively
6 weeks
6 months
12 months

Secondary outcome [4]

Post operative sedation using Ramsay sedation score

Timepoint [4]

In recovery - assessed at 10 minute intervals post-operatively for thirty minutes

Secondary outcome [5]

Post operative nausea & vomiting (anti-emetic use) - data linkage with patient medication chart

Timepoint [5]

Day 1

Secondary outcome [6]

Discharge time - length of hospital stay assessed from day of surgery until hospital discharge

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

King Edward Memorial Hospital - Subiaco

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

King Edward Memorial Hospital

Address [1]

374 Bagot Road
Subiaco, WA 6008

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

WNHS HREC

Ethics committee address [1]

Level 1, Children's Clinical
Research Facility (CCRF)
Princess Margaret Hospital
GPO Box D184
Perth WA 6840

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/06/2015

Approval date [1]

Ethics approval number [1]

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

Prof Roger Hart

Address

University of Western Australia
King Edward Memorial Hospital
374 Bagot Road
Subiaco, WA 6008

Country

Australia

Phone

+61893402222

Fax

roger.hart@uwa.edu.au

Contact person for public queries

Name

Jade Acton

Address

King Edward Memorial Hospital
374 Bagot Road
Subiaco, WA 6008

Country

Australia

Phone

+61893402222

Fax

jade.acton@health.wa.gov.au

Contact person for scientific queries

Name

Jade Acton

Address

King Edward Memorial Hospital
374 Bagot Road
Subiaco, WA 6008

Country

Australia

Phone

+61893402222

Fax

jade.acton@health.wa.gov.au

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.

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