Not Yet RecruitingPhase 4ACTRN12615000765527

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.


Sponsor

Professor Roger Hart

Enrollment

20 participants

Start Date

Aug 1, 2015

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 40 Yearss

Inclusion Criteria3

  • 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 Criteria5

  • 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

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Interventions

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

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


Locations(1)

King Edward Memorial Hospital - Subiaco

WA, Australia

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ACTRN12615000765527


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