NCT04251962

Role of Opioids in Epidural Solutions

The Role of Epidural Opioids in Pain Management After Abdominal Surgery in Adult Patients - a Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

It is unclear whether addition of opioids to epidural solutions for postoperative analgesia is beneficial. In this multicenter randomized double-blinded trial, we aim to test the primary hypothesis that epidural solutions containing only bupivacaine are as effective as solutions containing both bupivacaine and fentanyl in promoting analgesia in patients recovering from open abdominal surgery. We also aim to assess the incidence of epidural-induced hypotension, the difference in patient-reported opioid side-effects between the two groups. If we demonstrate no clinically important difference between the two interventions, clinicians will be able to substantially reduce the amount of opioids patients receive during their postoperative recovery, and potentially decrease the associated high incidence of opioid adverse effects in post-surgical patients.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine	epidural solution containing bupivacaine 0.1% in normal saline
DRUG	Fentanyl	Epidural solution containing fentanyl 3 mcg/ml (in addition to bupivacaine) in normal saline

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-03-02
• Completion: 2022-03-02
• First posted: 2020-02-05
• Last updated: 2023-04-12

Locations

1 site across 1 country: Israel