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Role of Opioids in Epidural Solutions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251962
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Israel Society of Anesthesiologists
Information provided by (Responsible Party):
michal roll, 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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Bupivacaine Drug: Fentanyl Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Role of Epidural Opioids in Pain Management After Abdominal Surgery in Adult Patients - a Randomized Clinical Trial
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bupivacaine
Epidural solution containing 0.1% bupivaacaine in normal saline
Drug: Bupivacaine
epidural solution containing bupivacaine 0.1% in normal saline
Other Name: Marcaine

Experimental: Bupivacaine + Fentanyl
Epidural solution containing 0.1% bupivacaine and 3 mcg/ml of fentanyl in normal saline
Drug: Bupivacaine
epidural solution containing bupivacaine 0.1% in normal saline
Other Name: Marcaine

Drug: Fentanyl
Epidural solution containing fentanyl 3 mcg/ml (in addition to bupivacaine) in normal saline
Other Name: Beatryl




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251962


Contacts
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Contact: Barak Cohen, MD +972-52-7360368 barakc@tlvmc.gov.il
Contact: Orr Goren, MD +972-52-7360330 goren.orr@gmail.com

Locations
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Israel
Division of Anesthesia, Pain and Critical Care, Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel
Contact: Barak Cohen, MD    +972-52-7360368    barakc@tlvmc.gov.il   
Contact: Orr Goren, MD    +972-52-7360330    goren.orr@gmail.com   
Principal Investigator: Barak Cohen, MD         
Sub-Investigator: Orr Goren, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Israel Society of Anesthesiologists
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Responsible Party: michal roll, Senior Anesthesiologist, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT04251962    
Other Study ID Numbers: 0489-19-TLV
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Fentanyl
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General