None listed
Conditions
Brief summary
The incision for major hepatobiliary surgery is across the right upper quadrant of the abdomen extending up the midline. Due to its size and position this incision can be very painful and affect normal breathing and mobilization. Inadequate control of pain can lead to impairment of ventilatory capacity with subsequent respiratory complications. Regional anaesthesia is often employed to improve pain control. It also has the benefit of reducing the requirement for opioids and therefore reducing opioid side effects, such as nausea, constipation and itch. Transversus abdominis plane (TAP) catheters have been found to be non-inferior to epidural anaesthesia for abdominal surgery. Current standard of practice at our institution is to place a TAP catheter and infuse a slow continuous infusion of local anaesthetic via a volumetric pump at a fixed rate. However, it is not known whether the most effective method of delivering local anaesthetic is via continuous infusion or intermittent bolus. Intermittent bolus has the presumed benefit of volume effect and further spread and therefore may provide better analgesia. We plan to compare timed intermittent boluses of regional anaesthesia (TIBRA) to a slow continuous infusion of local anaesthetic in terms of analgesic efficacy and opioid requirement. From January ’18, all eligible patients undergoing major hepatobiliary surgery will be identified in surgical clinic and invited to participate. The study is anticipated to run for 12 months. Participants will be randomised into either continuous or intermittent bolus group. The participants will not know which group they have been randomised to. Each day they will be visited by a member of the research team and asked to score their level of pain on a numerical rating scale. The total dose of other painkillers required will be documented, and they will be asked about any side effects they may have from these medications.
Interventions
Trial participants will be patients undergoing hepatobiliary surgery with a right subcostal incision. All patients included in trial will have a surgically placed transversus abdominis plane (TAP) catheter inserted at the end of the surgical procedure. They will have been randomised into two groups. One group will receive a continuous infusion of 0.2% ropivicaine at 5mls per hour via TAP catheter. The second group will be given intermittent boluses of 20mls of 0.2% ropivicaine every 4 hours via
Trial participants will be patients undergoing hepatobiliary surgery with a right subcostal incision. All patients included in trial will have a surgically placed transversus abdominis plane (TAP) catheter inserted at the end of the surgical procedure. They will have been randomised into two groups. One group will receive a continuous infusion of 0.2% ropivicaine at 5mls per hour via TAP catheter. The second group will be given intermittent boluses of 20mls of 0.2% ropivicaine every 4 hours via TAP catheter. The total daily dose of ropivicaine will be the same. The infusion pumps will programmed by the the treating anaesthetist who will not be blinded to the group allocation, but will have no involvement in the patients care once they have left the theatre recovery area. The infusions will continue for 72 hours after surgery and then catheters will then be removed by the ward nurses. The patients will be visited daily by the Acute Pain Service nurses and doctors. They will check the pump settings and connections, and the catheter insertion site. A separate nurse from the pain service who is blinded to the group allocation will be the one who collects data on each patient.
Sponsors
Dr Emilia Reece
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
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Liver resection or biliary surgery requiring right subcostal incision
Exclusion criteria
Major liver resection resulting in reduced liver function Major liver dysfunction Laparoscopic surgery Renal failure requiring dialysis Incision crossing the midline to left subcostal region
Outcome results
None listed