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

Phase 4

Completed

Conditions: Pain, Acute

Interventions: Drug: Bupivacaine
Drug: Fentanyl

Registration Number: NCT03307174

Lead Sponsor: University of California, San Francisco

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.

Detailed Description: See brief summary

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous epidural infusion	Bupivacaine	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.
Continuous epidural infusion	Fentanyl	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.
Programmed intermittent epidural bolus	Bupivacaine	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.
Programmed intermittent epidural bolus	Fentanyl	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.

Primary Outcome Measures

Name	Time	Method
Total Local Anesthetic Utilized in First 24 Hours	In first 24 hours	Total local anesthetic consumed while epidural in place, recorded on infusion pump

Secondary Outcome Measures

Name	Time	Method
Total Opioid Consumed	While epidural in place (up to 72 hours post operatively)	Total opioid consumed (intravenous or po) while epidural in place
Worst Reported 24 Hour Pain	While epidural in place (up to 72 hours postoperatively)	Minimum is 0, maximum is 10. 10 indicates highest pain severity.
Patient Satisfaction Score	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.
Average Pain Severity	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.
Incidence of Hypotension	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.
Average Pain Interference	While epidural in place (up to 72 hours postoperatively)	Minimum is 0, maximum is 10. 10 indicates highest pain interference.