Role of Opioids in Epidural Solutions

Tel Aviv Sourasky Medical Center

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Bupivacaine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT04251962

0489-19-TLV

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 2 patient groups

Bupivacaine

Experimental group

Description:

Epidural solution containing 0.1% bupivaacaine in normal saline

Treatment:

Drug: Bupivacaine

Bupivacaine + Fentanyl

Experimental group

Description:

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

Treatment:

Drug: Fentanyl

Drug: Bupivacaine