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OpenTrials
Completed

NCT Number: NCT03307174

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California San Francisco

San Francisco, California, 94158, United States

About this study

See brief summary

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Bupivacaine

Drug

Other names: 0.0625% bupivacaine

Fentanyl

Drug

Other names: 2mcg/ml fentanyl

Primary outcomes

  1. Total Local Anesthetic Utilized in First 24 Hours

    Time frame: In first 24 hours

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

Secondary outcomes

  1. Total Opioid Consumed

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

    Total opioid consumed (intravenous or po) while epidural in place

  2. Patient Satisfaction Score

    Time frame: While epidural in place (up to 72 hours postoperatively)

    Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory.

    Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction.

  3. Average Pain Severity

    Time frame: While epidural in place (up to 72 hours postoperatively)

    Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity.

  4. Incidence of Hypotension

    Time frame: While epidural in place (24 hours postoperatively)

    Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication.

  5. Worst Reported 24 Hour Pain

    Time frame: While epidural in place (up to 72 hours postoperatively)

    Minimum is 0, maximum is 10. 10 indicates highest pain severity.

  6. Average Pain Interference

    Time frame: While epidural in place (up to 72 hours postoperatively)

    Minimum is 0, maximum is 10. 10 indicates highest pain interference.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

A Prospective, Randomized Analysis of Epidural Anesthesia Using Programmed Intermittent Epidural Boluses Versus Continuous Epidural Infusion in Patients Undergoing Abdominal Surgery.

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2017
Registry last updated
May 12, 2020

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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