Role of Opioids in Epidural Solutions

Phase 4CompletedNCT04251962

Tel-Aviv Sourasky Medical Center135 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

135

Conditions

Postoperative Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Written informed consent 2. 18-85 years old 3. Undergoing open abdominal surgery (including colorectal, intestinal, gastric, pancreatic, hepatobiliary, urological, or gynecological surgery) 4. For which a clinical decision has been made to provide epidural analgesia preoperatively and extending to the post-operative period 5. Anticipated hospitalization of at least 2 nights Exclusion Criteria: 1. Known allergy to bupivacaine or fentanyl 2. Chronic liver disease, defined as cirrhosis, portal hypertension, or variceal bleeding 3. Patients under chronic alpha-blocking agents for hypertension 4. Clinical contraindications to epidural introduction, as judged by the anesthesia provider (thrombocytopenia, un-interrupted anticoagulation, clinically-significant atrio-ventricular conduction block, etc.) 5. Pregnant women

Outcomes

Primary Outcomes

Postoperative analgesia

A joint outcome of the difference in average pain score and a ratio of opioid consumption (in mg morphine equivalents) between the 2 study groups

Time frame: 48 postoperative hours

Secondary Outcomes

Clinically significant postoperative hypotension

Number of participants experiencing a composite of use of IV fluid boluses prescribed for hemodynamic support; sympathomimetic drugs administration; and holding or early discontinuation of the epidural infusion in order to recover blood pressure.