None listed
Conditions
Brief summary
This multicentre, randomised trial aims to determine whether a single preoperative dose of intrathecal morphine with local anaesthetic in patients undergoing elective minimally invasive major abdominal surgery improves quality of recovery as measured by the QoR-15 score on post operative day 1 where a difference of 6 is deemed clinically important. Patients will be randomised into the intervention group (preoperative injection of intrathecal morphine 200 mcg with local anaesthetic + multimodal analgesia) or the control group (multimodal analgesia). A dose increase of intrathecal morphine to 300mcg will occur after recruiting the first 100 patients and following review of safety data. Secondary outcomes of interest include cumulative opioid consumption over the first 3 postoperative days, dynamic and rest pain scores, return of bowel function, opioid related adverse events, hospital length of stay, persistent opioid use and pain at day 90.
Interventions
A single dose of intrathecal morphine (ITM) (200mcg, or 300mcg after safety review of the first 100 patients recruited) with local anaesthetic will be administered following full sterile precautions using a spinal needle immediately preoperatively by the treating anaesthesiologist to patients undergoing minimally invasive (laparoscopic, lap-assisted or robotic) major abdominal surgery. The procedure will be recorded in the patient's medical record and in the case report forms. Major surgery is t
A single dose of intrathecal morphine (ITM) (200mcg, or 300mcg after safety review of the first 100 patients recruited) with local anaesthetic will be administered following full sterile precautions using a spinal needle immediately preoperatively by the treating anaesthesiologist to patients undergoing minimally invasive (laparoscopic, lap-assisted or robotic) major abdominal surgery. The procedure will be recorded in the patient's medical record and in the case report forms. Major surgery is that where the predicted surgical time is greater than 2 hours. Multimodal analgesia including paracetamol, parecoxib and local anaesthetic (LA) (regional technique, infusion or infiltration) will be encouraged. These will be administered at the discretion of the treating anaesthesiologist intraoperatively. 50mcg Fentanyl boluses will be administered when heart rate or blood pressure are greater than 20% of baseline. Postoperative fentanyl Patient Controlled Analgesia (PCA) (10 mcg bolus, 10 min lockout) for 24 hours following ITM injection.
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
• Greater than or equal to 18 years old • Patients scheduled for elective major laparoscopic, lap-assisted or robotic abdominal surgery, and • Major surgery is that with a planned operative time of over 2 hours
Exclusion criteria
• < 18 years old • Patient declines enrolment or inability to consent • Contraindication to intrathecal morphine • Contraindication to a neuraxial injection, including; injection site concerns, coagulopathy (including administration of anticoagulant), or untreated sepsis • Cognitive impairment or language proficiency leading to inability to complete QoR-15 questionnaire or understand the pain scores • Chronic pain, including baseline opioid use prior to hospital admission
Outcome results
None listed