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
Phase 4
- Conditions
- Chronic PainEndometriosisAnaesthesiology - Pain managementReproductive Health and Childbirth - Other reproductive health and childbirth disorders
- Registration Number
- ACTRN12615000765527
- Lead Sponsor
- Professor Roger Hart
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 20
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS pain scores [6 months post operatively];QOL scores using SF-12 and EQ-5D Quality of Life Scores[6 months post operatively]
- Secondary Outcome Measures
Name Time Method VAS pain scores[Day 1, 6 weeks, 12 months];Quality of Life Scores using SF-12 and EQ-5D Scores[6 weeks and 12 months post operatively];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.[24 hours post-operatively<br>6 weeks<br>6 months<br>12 months];Post operative sedation using Ramsay sedation score[In recovery - assessed at 10 minute intervals post-operatively for thirty minutes];Post operative nausea & vomiting (anti-emetic use) - data linkage with patient medication chart[Day 1];Discharge time - length of hospital stay assessed from day of surgery until hospital discharge[At discharge]