NCT04251962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Aug 2020

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2022

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

1.6 years

First QC Date

January 16, 2020

Last Update Submit

April 11, 2023

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • 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

    48 postoperative hours

Secondary Outcomes (1)

  • Clinically significant postoperative hypotension

    48 postoperative hours

Other Outcomes (2)

  • Recovery of gastrointestinal function

    Throughout the postoperative hospital stay, up to 30 days

  • Opioid-related side effects

    48 postoperative hours

Study Arms (2)

Bupivacaine

EXPERIMENTAL

Epidural solution containing 0.1% bupivaacaine in normal saline

Drug: Bupivacaine

Bupivacaine + Fentanyl

EXPERIMENTAL

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

Drug: BupivacaineDrug: Fentanyl

Interventions

BupivacaineDRUG

epidural solution containing bupivacaine 0.1% in normal saline

Also known as: Marcaine
BupivacaineBupivacaine + Fentanyl
FentanylDRUG

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

Also known as: Beatryl
Bupivacaine + Fentanyl

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineFentanyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Anesthesiologist

Study Record Dates

First Submitted

January 16, 2020

First Posted

February 5, 2020

Study Start

August 1, 2020

Primary Completion

March 2, 2022

Study Completion

March 2, 2022

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)