None listed
Conditions
Brief summary
Studies have shown that 20-40% of patients experience severe pain following haemorrhoidectomy surgery, often requiring opioid analgesics. Although various pain management strategies have been explored, no universally accepted approach has emerged. Emerging opioids have shown great promise for postoperative pain after haemorrhoidectomy surgery. Tapentadol and buprenorphine are both atypical opioids with multimodal action and reduce gastrointestinal side effects due to their opioid sparing effects, that may be beneficial for patients after haemorrhoidectomy surgery. However, these two opioids have not been directly compared, emphasising the need for research to inform safe prescribing. This RCT directly aims to directly compare the efficacy of buprenorphine and tapentadol (primary: AUC bowel motion pain) and safety (AEs, constipation), informing safer prescribing to accelerate recovery, reduce opioid loads, and mitigate population-level harms in opioid-vulnerable surgical cohorts.
Interventions
This will be an open-label randomised controlled study.
The intervention arm will be buprenorphine sublingual tablets, plus usual care post-haemorrhoidectomy once patient is tolerating oral tablets.
Dosage and duration will be guided by the product information and adjusted according to individual pain response and clinical judgement. Maximum dose is 1.6mg in 24 hours. Participants will be provided study medications on discharge, receiving a supply of buprenorphine tablets of no more than 20 t
This will be an open-label randomised controlled study. The intervention arm will be buprenorphine sublingual tablets, plus usual care post-haemorrhoidectomy once patient is tolerating oral tablets. Dosage and duration will be guided by the product information and adjusted according to individual pain response and clinical judgement. Maximum dose is 1.6mg in 24 hours. Participants will be provided study medications on discharge, receiving a supply of buprenorphine tablets of no more than 20 tablets. The prescribing of buprenorphine will be guided by the treating surgeon, anaesthetist, and pain specialist, with suggested dosing guides provided by the study team from evidence-based resources. During admission, nursing staff will administer medications for patients. Usual care will be determined by each individual hospital's processes, but may include regular paracetamol and non-steroidal anti-inflammatory medications, and osmotic laxatives and salt baths when required. As the dosing is on an 'as needed' basis, participants may or may not use the medication in-hospital. Strategies to monitor adherence to the intervention during admission include review of the medication charts and patient notes. Following discharge, the study team will rely on patient-self reports daily to monitor adherence. Final data collection will be via telephone 3-months after the surgery. The research team will ask about opioid use to assess for persistent use, opioid-related adverse events, nonopioid analgesic use, and benzodiazepine use.
Sponsors
Prince of Wales Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged equal to or greater than 18 years, elective haemorrhoidectomy, postoperative opioid requirement (clinician judgement), English proficient; telephone/internet access.
Exclusion criteria
Repeat surgery in the last 6 months (i.e., has had a haemorrhoidectomy in the last 6 months), cognitive impairment, chronic opioid use (i.e. daily use for the last 3 months or more), cancer/palliative care, substance disorder, contraindications to study drugs
Outcome results
None listed