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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307174
• Other study ID #: 15-18354
• Status: Completed
• Phase: Phase 4
• Start date: April 14, 2016
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Drug:
• Bupivacaine

• Fentanyl

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total Opioid Consumed	Total opioid consumed (intravenous or po) while epidural in place	While epidural in place (up to 72 hours post operatively)
Secondary	Patient Satisfaction Score	Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory.; Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction.	While epidural in place (up to 72 hours postoperatively)
Secondary	Average Pain Severity	Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity.	While epidural in place (up to 72 hours postoperatively)
Secondary	Incidence of Hypotension	Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication.	While epidural in place (24 hours postoperatively)
Secondary	Worst Reported 24 Hour Pain	Minimum is 0, maximum is 10. 10 indicates highest pain severity.	While epidural in place (up to 72 hours postoperatively)
Secondary	Average Pain Interference	Minimum is 0, maximum is 10. 10 indicates highest pain interference.	While epidural in place (up to 72 hours postoperatively)