None listed
Conditions
Brief summary
Methadone is an opioid medication used as a pain reliever medication and as a way of reducing withdrawal symptoms for those patients addicted to opioids. It is in the same class of drugs as codeine, oxycodone, morphine and fentanyl. These drugs are commonly employed to manage acute pain, such as that inflicted by surgery. Due to opioids having significant side effects alongside addictive properties, reducing the dose of such potent drugs is important, especially to avoid patients becoming dependent on them. Such adverse effects range from nausea, constipation and sedation to respiratory suppression, overdose and death. Laparoscopic surgery is a minimally invasive, moderately painful procedure commonly employed in general and gynaecological cases. Such procedures, especially gynaecological surgeries can be notoriously difficult to manage post-operative pain where no ideal analgesic regimen has been established. Conventionally, potent opioids like fentanyl and morphine are employed during surgery with patients frequently requiring opioids in both the PACU, and after discharge. This carries substantial risks and adverse effects. Methadone may offer an appealing alternative to current strategies. If the amount of post-operative opioid required can be reduced, not only will patients benefit in terms of greater comfort and fewer dose-related opioid adverse effects, but recent concerns about overprescribing of discharge opioids may be alleviated Hypothesis This study hypothesises that intraoperative methadone use will reduce PACU opioid consumption. As a result, we also predict that we will be able to reduce opioid dose (in morphine equivalents) consumed after discharge, at one week.
Interventions
intervention drug: Methadone (0.15mg/kg, up to 10mgs) as compared to standard care using morphine or fentanyl during laparoscopic procedure. this will be a single intra-operative dose administered via intravenous infusion. methadone will be administered at the time of incision closure.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
- Adults undergoing general surgery laparoscopy as well as gynaecology laparoscopy at Albury and Wodonga Hospitals - Planned same-day discharge - Able to speak and read English
Exclusion criteria
- Morbid obesity - Obstructive sleep apnoea, treated with CPAP, or diagnosed but untreated - Significant renal or liver dysfunction - Pregnant or breastfeeding women - Preoperative opioid dependence - Known or suspected allergy to methadone - Anaesthetist wish to avoid methadone administration for any reason - Undergoing laparoscopic bowel resection or laparoscopic nephrectomy - Undergoing emergency laparoscopic operations (e.g. appendicectomy, ectopic pregnancy) - Patients with long QT syndrome, and any on whom a preop ECG reveals a long QT interval - Anyone already on an SSRI (serotonin syndrome risk)
Outcome results
None listed