Overview

Role of Opioids in Epidural Solutions

Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborator:
Israel Society of Anesthesiologists
Treatments:
Bupivacaine
Fentanyl
Pharmaceutical Solutions