None listed
Conditions
Brief summary
This study aims to compare the efficacy and safety of two methods of pain relief after major abdominal surgery: intrathecal morphine (IT) standard of care verses abdominal wall regional anaesthesia. The abdominal wall regional anaesthesia is a bolus injection of local anaesthetic via ultrasound placed subcostal transversus abdominis plane (S-TAP) catheters. Although IT is the current standard practice for pain relief in this type of surgery, it has also been associated with significant complications including nausea, vomiting, respiratory depression, and hypotension. There is increasing evidence that S-TAP may be able to provide equally satisfactory pain relief and associated with fewer complications. However, no study has been conducted that comprehensively compared using multidimensional analysisto assess the pain control achieved, as well as safety, of these two techniques. This study is a randomised controlled triple blind control trial. Patients having open hepatobiliary and pancreatic (HPB) surgery at Auckland City Hospital will be randomised to receive either IT or S-TAP for pain relief after surgery. Subjects, treating physicians and investigator/outcome assessors will be blinded to the randomisation results. Patients will be followed up to assess: 1)Pain and analgesia requirement in the first 48 hours after surgery 2)Physical assessment using the Time Up and Go test at 72 hours after surgery 3) Pain assessment at 7 days after surgery 4) Change in disability free survival (WHO-DAS questionnaire)and pain assessment at 90 days after surgery The study also includes comprehensive adverse event reporting.
Interventions
Abdominal wall regional anesthesia in the form of local anaesthetic bolused via ultrasound placed subcostal transversus abdominis plane (S-TAP) catheters, after open hepatobiliary and pancreatic surgery. This will be administered immediately at completion of surgery while patient is still in the operating room.
Detailed description of technique:
Spinal with 2ml of 0.5% bupivacaine plus 0.3mL saline + Surgically placed TAP and rectus sheath catheters, each with a 30ml (to a maximum 1mL/kg) hand
Abdominal wall regional anesthesia in the form of local anaesthetic bolused via ultrasound placed subcostal transversus abdominis plane (S-TAP) catheters, after open hepatobiliary and pancreatic surgery. This will be administered immediately at completion of surgery while patient is still in the operating room. Detailed description of technique: Spinal with 2ml of 0.5% bupivacaine plus 0.3mL saline + Surgically placed TAP and rectus sheath catheters, each with a 30ml (to a maximum 1mL/kg) hand bolus of 0.2% ropivacaine at the end of surgery, followed by 20mL (to a maximum 0.65mL/kg) of 0.2% ropivacaine every 4 hours via a CADD®Solis pump for 72hours.
Sponsors
Dr Helen Lindsay
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undergoing open hepatobiliary and/or pancreatic surgery at Auckland City Hospital
Exclusion criteria
1) Contraindication to spinal block at the discretion of the treating anaesthetist, including coagulopathy (INR >/= 1.4 or platelets < 80 x 10^9/L) or abnormality precluding spinal block 2) Inability to identify with ultrasound the appropriate tissue planes for safe regional catheter placement 3) Patient refusal 4) Objection of the treating anaesthetist or surgeon for the patient to be enrolled into the study
Outcome results
None listed