Role of Opioids in Epidural Solutions

NCT ID: NCT04251962

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-03-02

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Bupivacaine

Epidural solution containing 0.1% bupivaacaine in normal saline

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

epidural solution containing bupivacaine 0.1% in normal saline

Bupivacaine + Fentanyl

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

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

epidural solution containing bupivacaine 0.1% in normal saline

Fentanyl

Intervention Type: DRUG

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

Interventions

Bupivacaine

epidural solution containing bupivacaine 0.1% in normal saline

Intervention Type: DRUG

Fentanyl

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

Intervention Type: DRUG

Other Intervention Names

Marcaine; Beatryl

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Israel Society of Anesthesiologists

UNKNOWN

Sponsor Role: collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Barak Cohen, MD

Senior Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Division of Anesthesia, Pain and Critical Care, Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

0489-19-TLV

Identifier Type: -

Identifier Source: org_study_id