RecruitingPhase 4ACTRN12622000625774

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


Sponsor

Alfred Health

Enrollment

80 participants

Start Date

Oct 25, 2022

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Major abdominal surgery — such as removal of part of the bowel or the stomach — is associated with significant pain afterward, and poorly managed post-operative pain makes recovery harder and longer. A common approach is to give a single injection of morphine into the spinal fluid (intrathecal morphine) just before the operation, which provides good short-term pain relief. But this wears off within 24 hours, and what comes after — whether an epidural catheter for ongoing morphine delivery, or a patient-controlled IV opioid pump — matters greatly for recovery. This feasibility study compares giving epidural morphine (via a thin tube in the back) versus a patient-controlled IV opioid pump after the initial spinal morphine injection, to find out which provides better pain control, fewer side effects, and less total opioid use. The results will help design a larger definitive trial. You may be eligible if you are between 18 and 75 years old and are scheduled for elective major open abdominal surgery expected to last more than 2 hours. People with a history of chronic pain or regular opioid use, allergies to the study drugs, certain spinal conditions, cognitive impairment, or who are pregnant or breastfeeding are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

The Alfred - Melbourne

VIC, Australia

Peter MacCallum Cancer Centre - Melbourne

VIC, Australia

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ACTRN12622000625774