NCT03307174 is a Phase 4 clinical trial of Bupivacaine in Pain, Acute, sponsored by University of California, San Francisco.

Who is sponsoring NCT03307174?

NCT03307174 is sponsored by University of California, San Francisco.

What drugs are being tested in NCT03307174?

Interventions in NCT03307174: Bupivacaine, Fentanyl.

What condition does NCT03307174 study?

NCT03307174 studies Pain, Acute.

Is NCT03307174 still recruiting?

NCT03307174 is currently completed. Last updated 12 May 2020.

Are results published for NCT03307174?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-05-12 · How we verify

NCT03307174

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Results posted Last updated 12 May 2020

What this trial tests

Phase 4 trial testing Bupivacaine in Pain, Acute in 120 participants. Completed in 28 February 2019.

Timeline

14 April 2016

Primary endpoint
28 February 2019

28 February 2019

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	120
Start date	14 April 2016
Primary completion	28 February 2019
Estimated completion	28 February 2019
Sites	1 location across United States

Drugs / interventions tested

Bupivacaine (BUPIVACAINE) — full drug profile →
Fentanyl (fentanyl) — full drug profile →

Conditions studied

Pain, Acute — all drugs for Pain, Acute →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Pain, Acute. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Local Anesthetic Utilized in First 24 Hours Primary · In first 24 hours

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

Group	Value	95% CI
Continuous Epidural Infusion	126	120 – 134
Programmed Intermittent Epidural Bolus	123	115 – 136

Total Opioid Consumed Secondary · While epidural in place (up to 72 hours post operatively)

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

24 hours postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	12	0 – 28
Programmed Intermittent Epidural Bolus	16	0 – 27

24 - 48 hours postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	0	0 – 25
Programmed Intermittent Epidural Bolus	0	0 – 30

48 - 72 hrs postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	0	0 – 21
Programmed Intermittent Epidural Bolus	1	0 – 18

Patient Satisfaction Score Secondary · 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.

24 hours postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	9	8 – 10
Programmed Intermittent Epidural Bolus	8	6.5 – 10

24 - 48 hours postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	9	7 – 10
Programmed Intermittent Epidural Bolus	9	7.3 – 10

48 - 72 hours postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	9	7 – 10
Programmed Intermittent Epidural Bolus	9	8 – 10

Average Pain Severity Secondary · 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.

24 hours postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	3	1 – 4
Programmed Intermittent Epidural Bolus	5	2 – 5

24 - 48 hours postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	3	1 – 4
Programmed Intermittent Epidural Bolus	2	1 – 5

48 - 72 hours postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	3	1 – 4
Programmed Intermittent Epidural Bolus	3	1 – 4

Incidence of Hypotension Secondary · 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.

Group	Value	95% CI
Continuous Epidural Infusion	9
Programmed Intermittent Epidural Bolus	18

Worst Reported 24 Hour Pain Secondary · While epidural in place (up to 72 hours postoperatively)

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

24 hours postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	5	2 – 7
Programmed Intermittent Epidural Bolus	8	4 – 9

24 - 48 hours postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	6	3 – 8
Programmed Intermittent Epidural Bolus	6	3 – 8

48 - 72 hours postoperativley

Group	Value	95% CI
Continuous Epidural Infusion	7	5 – 8
Programmed Intermittent Epidural Bolus	6	3 – 8

Average Pain Interference Secondary · While epidural in place (up to 72 hours postoperatively)

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

24 hours postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	2	0 – 4
Programmed Intermittent Epidural Bolus	3	1 – 5

24 - 48 hours postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	1	0 – 4
Programmed Intermittent Epidural Bolus	1	0 – 4

48 - 72 hours postoperatively

Group	Value	95% CI
Continuous Epidural Infusion	2	0 – 4
Programmed Intermittent Epidural Bolus	1	0 – 3

Adverse events — posted to ClinicalTrials.gov

Time frame: Data collected from day of surgery until removal of epidural, on average epidurals were removed between day 1 and 3. Rare clinical scenarios, epidurals can remain as long as 7 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Continuous Epidural Infusion

Serious: 0/44 (0%)

Deaths: 0/44

Programmed Intermittent Epidural Bolus

Serious: 0/52 (0%)

Deaths: 0/52

Other adverse events (1 terms — click to expand)

Reaction	System	Continuous Epidural Infusion	Programmed Intermittent Ep…
Hypotension	Cardiac disorders	—	—

Data from ClinicalTrials.gov NCT03307174 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Currently open trials in the same condition.

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Other University of California, San Francisco trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03307174 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
Last refreshed: 12 May 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03307174.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03307174

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Bupivacaine

Other recruiting trials for Pain, Acute

Other University of California, San Francisco trials

Verify against primary sources