Role of Opioids in Epidural Solutions

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Bupivacaine; Drug: Fentanyl

• Registration Number: NCT04251962
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Study Start: 2020-08-01
• Primary Completion: 2022-03-02
• Study Completion: 2022-03-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine	Bupivacaine	Epidural solution containing 0.1% bupivaacaine in normal saline
Bupivacaine + Fentanyl	Bupivacaine	Epidural solution containing 0.1% bupivacaine and 3 mcg/ml of fentanyl in normal saline
Bupivacaine + Fentanyl	Fentanyl	Epidural solution containing 0.1% bupivacaine and 3 mcg/ml of fentanyl in normal saline

Primary Outcome Measures

Name	Time	Method
Postoperative analgesia	48 postoperative hours	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

Secondary Outcome Measures

Name	Time	Method
Clinically significant postoperative hypotension	48 postoperative hours	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.

Trial Locations

Locations (1)

Division of Anesthesia, Pain and Critical Care, Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel