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Analgesia for major abdominal surgery: A feasibility study using a combination of intrathecal and epidural morphine

Analgesia for major abdominal surgery: A feasibility study using a combination of intrathecal and epidural morphine

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000625774
Enrollment
66
Registered
2022-04-28
Start date
2022-10-25
Completion date
2025-01-17
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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 s

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

Sponsors

Alfred Health
Lead SponsorHospital

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 75 Years
Healthy volunteers
No

Inclusion criteria

Eligible patients will be; • > 18 years old • Patients scheduled for elective major (> 2 hours surgical time) open abdominal surgery

Exclusion criteria

• 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

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026