None listed
Conditions
Brief summary
Major abdominal surgery is a common procedure associated with significant postoperative pain and morbidity. The importance of high quality perioperative care is clear, and effective postoperative analgesia is fundamental to recovery. Intrathecal Morphine (ITM) is an increasingly popular analgesic option in major abdominal surgery and in laparascopic colorectal surgery, has been reported to reduce pain scores and total opioid consumption. In the context of a worldwide opioid epidemic, strategies to minimise opioid use whilst optimising patient comfort and functional recovery are priorities in the perioperative setting. We believe ITM will be superior to intravenous analgesia alone in terms of quality of recovery, cost saving and opioid-sparing in the context of similar or lower side effects. The results of this preliminary feasibility study will be used to design a large-scale phase III, multicentre trial with the objective of obtaining outcomes that will accurately inform clinical practice.
Interventions
A single dose of intrathecal morphine will be administered immediately pre operatively in inpatients undergoing elective, major laparoscopic abdominal surgery. Major surgery is that where the predicted surgical time is greater than 2 hours. Morphine dose 0.15 mg - 0.4 mg, chosen at the discretion of the treating anaesthetist, based on the type of surgery, and patient factors in this pragmatically designed trial. All other components of anaesthesia and intra operative analgesia will be at the dis
A single dose of intrathecal morphine will be administered immediately pre operatively in inpatients undergoing elective, major laparoscopic abdominal surgery. Major surgery is that where the predicted surgical time is greater than 2 hours. Morphine dose 0.15 mg - 0.4 mg, chosen at the discretion of the treating anaesthetist, based on the type of surgery, and patient factors in this pragmatically designed trial. All other components of anaesthesia and intra operative analgesia will be at the discretion of the treating anaesthetist. Post operatively, patient controlled analgesia (PCA) with intravenous fentanyl (10-20mcg, 5-10min lock out) will be prescribed.
Sponsors
Dr Katrina Pirie
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 No maximum
Healthy volunteers
No
Inclusion criteria
• > 18 years old • Patients scheduled for elective major laparoscopic or lap-assisted abdominal surgery, and • Planned operative time of over 2 hours
Exclusion criteria
- < 18 years old - Patient decline or inability to consent - Contraindication to morphine - Contraindication to a neuraxial injection including local site concerns, coagulopathy (including anticoagulant medication within safe timeframe), raised intracranial pressure, and 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 - Women lactating or pregnant
Outcome results
None listed