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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

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.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000765527
Enrollment
20
Registered
2015-07-23
Start date
2015-08-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

IV methadone 0.2mg/kg (after induction of anaesthesia) and 200mL levobupivocaine 0.625% intraperitoneal (at completion of surgical case)

Sponsors

Professor Roger Hart
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026