Trial | NCT04251962  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    135
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.
Study Started
Aug 01
2020
Primary Completion
Mar 02
2022
Study Completion
Mar 02
2022
Last Update
Apr 12
2023

Drug Bupivacaine

epidural solution containing bupivacaine 0.1% in normal saline

  • Other names: Marcaine

Drug Fentanyl

Epidural solution containing fentanyl 3 mcg/ml (in addition to bupivacaine) in normal saline

  • Other names: Beatryl

Bupivacaine Experimental

Epidural solution containing 0.1% bupivaacaine in normal saline

Bupivacaine + Fentanyl Experimental

Epidural solution containing 0.1% bupivacaine and 3 mcg/ml of fentanyl in normal saline

Criteria 

Inclusion Criteria:

Written informed consent
18-85 years old
Undergoing open abdominal surgery (including colorectal, intestinal, gastric, pancreatic, hepatobiliary, urological, or gynecological surgery)
For which a clinical decision has been made to provide epidural analgesia preoperatively and extending to the post-operative period
Anticipated hospitalization of at least 2 nights

Exclusion Criteria:

Known allergy to bupivacaine or fentanyl
Chronic liver disease, defined as cirrhosis, portal hypertension, or variceal bleeding
Patients under chronic alpha-blocking agents for hypertension
Clinical contraindications to epidural introduction, as judged by the anesthesia provider (thrombocytopenia, un-interrupted anticoagulation, clinically-significant atrio-ventricular conduction block, etc.)
Pregnant women
No Results Posted