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Role of Opioids in Epidural Solutions

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Bupivacaine
Fentanyl
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bupivacaine

Bupivacaine + Fentanyl

Arm Description

Epidural solution containing 0.1% bupivaacaine in normal saline

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 16, 2020
Last Updated
April 11, 2023
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Israel Society of Anesthesiologists
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1. Study Identification

Unique Protocol Identification Number
NCT04251962
Brief Title
Role of Opioids in Epidural Solutions
Official Title
The Role of Epidural Opioids in Pain Management After Abdominal Surgery in Adult Patients - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
March 2, 2022 (Actual)
Study Completion Date
March 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Israel Society of Anesthesiologists

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Experimental
Arm Description
Epidural solution containing 0.1% bupivaacaine in normal saline
Arm Title
Bupivacaine + Fentanyl
Arm Type
Experimental
Arm Description
Epidural solution containing 0.1% bupivacaine and 3 mcg/ml of fentanyl in normal saline
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
epidural solution containing bupivacaine 0.1% in normal saline
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Beatryl
Intervention Description
Epidural solution containing fentanyl 3 mcg/ml (in addition to bupivacaine) in normal saline
Primary Outcome Measure Information:
Title
Postoperative analgesia
Description
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 Outcome Measure Information:
Title
Clinically significant postoperative hypotension
Description
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.
Time Frame
48 postoperative hours
Other Pre-specified Outcome Measures:
Title
Recovery of gastrointestinal function
Description
Time to first postoperative bowel movement
Time Frame
Throughout the postoperative hospital stay, up to 30 days
Title
Opioid-related side effects
Description
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)
Time Frame
48 postoperative hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Anesthesia, Pain and Critical Care, Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Opioids in Epidural Solutions

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