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NCT Number: NCT04251962

Role of Opioids in Epidural Solutions

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

epidural solution containing bupivacaine 0.1% in normal saline

Other names: Marcaine

Fentanyl

Drug

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

Other names: Beatryl

Primary outcomes

  1. Postoperative analgesia

    Time frame: 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 outcomes

  1. Clinically significant postoperative hypotension

    Time frame: 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.

Other outcomes

  1. Recovery of gastrointestinal function

    Time frame: Throughout the postoperative hospital stay, up to 30 days

    Time to first postoperative bowel movement

  2. Opioid-related side effects

    Time frame: 48 postoperative hours

    A composite of opioid-related side-effects as measured by the Opioid-Related Symptom Distress Scale (OR-SDS) questionnaire (higher scores represent more side-effects and related distress, scores are given on multiple dimensions)

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Collaborators

  • Israel Society of Anesthesiologists

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2020
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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