Analgesia for major abdominal surgery: A feasibility study using a combination of intrathecal and epidural morphine
Alfred Health
80 participants
Oct 25, 2022
Interventional
Conditions
Summary
Major abdominal surgery is a common procedure associated with significant postoperative pain and morbidity. Poorly controlled pain negatively impacts upon recovery following surgery. Intrathecal morphine is an increasingly popular alternative analgesic option in major abdominal surgery but has a limited duration of effect. Epidural morphine can be continued postoperatively for as long as the epidural catheter remains in situ. A direct comparison of epidural morphine and intravenous opioid PCA following preoperative intrathecal morphine for major abdominal surgery has not been conducted. We believe epidural morphine will be superior to intravenous opioid PCA 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
Eligibility
Inclusion Criteria3
- Eligible patients will be;
- > 18 years old
- Patients scheduled for elective major (> 2 hours surgical time) open abdominal surgery
Exclusion Criteria8
- Age >75 years
- Hypersensitivity reactions to any of the study drugs
- Contraindication to neuraxial (local site concerns, coagulopathy or untreated sepsis)
- Patient decline or inability to consent
- 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
- Contraindication to intrathecal morphine
- Lactating or pregnant women
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
1. Epidural Morphine Group o Combined spinal epidural prior to induction of anaesthesia Single lumbar intrathecal injection of preservative-free morphine • 300 mcg in 2 - 4 ml 0.5% bupivacaine Lumbar epidural catheter inserted, labelled and capped o Intravenous fentanyl PCA (fPCA) post op with 10 – 20 mcg bolus / 5 - 10 minute lockout o After 24 hours Acute Pain Service (APS) to test the epidural with 4 ml 2% lignocaine with 1 in 200000 Adrenaline to ensure correct placement with onset of a sensory block, and exclusion of spinal block o APS to administer 3 mg of epidural morphine with 3 ml normal saline 0.9% flush. o APS to repeat epidural bolus 12 – 24 hourly up until 5 days post procedure if required as long as pain NRS is 3 or greater at the time of review • Intravenous fentanyl PCA to continue whilst epidural in-situ • Rescue analgesia for NRS pain score > 4 o Contact APS, to consider clinical situation, no restrictions as per protocol o APS to consider the clinical situation and the following options first, prior to following local protocols to control pain - Recommencing IV fPCA if ceased - Epidural bolus fentanyl 50 mcg - Oral analgesic including opioids o Following rescue analgesia, respiratory observations every 30 minutes for the two hours after administration, then back to hourly PCA observations • If sedation score > 2 or RR < 8, remove intravenous fentanyl PCA, alert medical team and consider naloxone administration. • Epidural site must be checked twice daily. Should fever, or signs of local site infection occur, the epidural catheter must be removed following timing of anticoagulation confirmed, and consultation with APS Protocol adherence will be determined following completion of patient follow up at 30 days upon review of the electronic medical record
Locations(2)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12622000625774