Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery.

NCT03307174 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 15-18354
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior studies in labor epidurals have demonstrated that a programmed intermittent bolus application of local anesthesia can improve pain control by reducing the amount of local anesthetic required as well as improve patient satisfaction when compared to continuous epidural infusions. The effects of programmed intermittent bolus of epidural local anesthetics compared to continuous epidural infusions in a surgical setting have yet to be elucidated. Our goal is to evaluate the use of programmed intermittent bolus compared to continuous epidural infusion in a surgical patient population. We plan to enroll patients already undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology, urological where epidural anesthesia can be employed. The primary endpoints of the study will be the total local anesthetic consumption and total opioid consumption as surrogate markers for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional measurements, patient satisfaction, and incidence of hypotension.

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Total Local Anesthetic Utilized in First 24 Hours

  Total local anesthetic consumed while epidural in place, recorded on infusion pump

  In first 24 hours

Secondary Outcomes (6)

• Total Opioid Consumed

  While epidural in place (up to 72 hours post operatively)

• Patient Satisfaction Score

  While epidural in place (up to 72 hours postoperatively)

• Average Pain Severity

  While epidural in place (up to 72 hours postoperatively)

• Incidence of Hypotension

  While epidural in place (24 hours postoperatively)

• Worst Reported 24 Hour Pain

  While epidural in place (up to 72 hours postoperatively)

Study Arms (2)

Continuous epidural infusion

ACTIVE COMPARATOR

At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.

Drug: Bupivacaine; Drug: Fentanyl

Programmed intermittent epidural bolus

EXPERIMENTAL

For the programmed intermittent epidural bolus group: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata.

Drug: Bupivacaine; Drug: Fentanyl

Interventions

Bupivacaine DRUG

Also known as: 0.0625% bupivacaine

Continuous epidural infusion; Programmed intermittent epidural bolus

Fentanyl DRUG

Also known as: 2mcg/ml fentanyl

Continuous epidural infusion; Programmed intermittent epidural bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesia physical classification I - III, scheduled for surgery with anticipated an epidural anesthesia (including but not limited to colorectal, surgical oncology, urology, gynecology) as part of their perioperative treatment

You may not qualify if:

• Age younger than 18 years of age, non-English speaking, contraindication for neuraxial anesthesia (such as, but not limited to coagulopathy, infection at site, allergy to local anesthetic), preexisting neurologic deficits, inability to consent due to cognitive dysfunction, patients with pain numeric rating score \> 5 each day for greater than 3 months, daily opioid consumption \> 100 oral morphine equivalents for 14 consecutive days prior to surgery, patient refusal.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Bupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Paul Su
• Organization: University of California San Francisco

paul.su@Ucsf.edu

415-885-7246

Study Officials

• Matthias Behrends, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 11, 2017
• Study Start: April 14, 2016
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)