None listed
Conditions
Brief summary
Pelvic exenteration is a life-changing surgical procedure for patients with advanced or recurrent pelvic cancers. This procedure is associated with significant postoperative morbidity and increased level of pain. To manage this, oxycodone is currently the mainstay opioid used for postoperative pain control. However, this drug is commonly associated with serious side effects, slowing patient recovery, and increasing the length of hospital stay. A new pain management strategy, using sublingual buprenorphine, may improve outcomes and contribute to better patient recovery. However, the comparative effectiveness of this drug has not been evaluated in a clinical trial. Therefore, we will conduct the first pilot randomised controlled trial, to determine the feasibility and acceptability of administering sublingual buprenorphine when compared to oral oxycodone following pelvic exenteration surgery.
Interventions
Arm 1: Oxycodone 5-10 mg oral tablet + Placebo [lactose tablet] sublingual every 3 hours as needed
Arm 2: Buprenorphine 200-400 mcg sublingual tablet + Placebo [lactose tablet] oral every 3 hours as needed
Duration:
Initiated as soon as possible postoperatively and continued for up to 7 days after the first dose
Mode:
Oral and sublingual tablets
Administration:
Administered by registered nurses. Dose within range selected based on pain scores and clinical judgement. Adherence to intervention
Arm 1: Oxycodone 5-10 mg oral tablet + Placebo [lactose tablet] sublingual every 3 hours as needed Arm 2: Buprenorphine 200-400 mcg sublingual tablet + Placebo [lactose tablet] oral every 3 hours as needed Duration: Initiated as soon as possible postoperatively and continued for up to 7 days after the first dose Mode: Oral and sublingual tablets Administration: Administered by registered nurses. Dose within range selected based on pain scores and clinical judgement. Adherence to intervention is monitored via electronic medical records.
Sponsors
University of Sydney
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 No maximum
Healthy volunteers
No
Inclusion criteria
-Pelvic exenteration surgery for advanced primary or recurrent pelvic (e.g., rectal, bladder, prostate, uterine, and other) malignancies -Age 18 years or more
Exclusion criteria
-The treating clinician does not consider both drugs to be a suitable option for the patient or does not consider the trial to be in the best interests of the patient based on precautions with study drugs or previous adverse events attributed to study drugs -Use of monoamine oxidase inhibitors (MAOI) within 14 days of planned surgery. These include: phenelzine, tranylcypromine, moclobemide, selegiline, rasagiline, linezolid. -The treating team intends to use epidural analgesia perioperatively or if epidural analgesia is used prior to randomisation -Unable to provide informed consent
Outcome results
None listed