NCT04458467 is a NA clinical trial of Continuous Infusion in Pain, Acute, sponsored by University of California, San Diego.

Who is sponsoring NCT04458467?

NCT04458467 is sponsored by University of California, San Diego.

What drugs are being tested in NCT04458467?

Interventions in NCT04458467: Continuous Infusion, Automated Intermittent Boluses.

What condition does NCT04458467 study?

NCT04458467 studies Pain, Acute, Anesthesia, Local, Trauma Injury.

Is NCT04458467 still recruiting?

NCT04458467 is currently completed. Last updated 30 June 2022.

Are results published for NCT04458467?

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

Last reviewed 2022-06-30 · How we verify

NCT04458467

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

Perineural Local Anesthetic Administration With a Continuous Infusion Versus Automatic Intermittent Boluses

Completed NA Results posted Last updated 30 June 2022

What this trial tests

NA trial testing Continuous Infusion in Pain, Acute in 71 participants. Completed in 16 March 2021.

Timeline

15 July 2020

Primary endpoint
12 March 2021

16 March 2021

Quick facts

Lead sponsor	University of California, San Diego
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	71
Start date	15 July 2020
Primary completion	12 March 2021
Estimated completion	16 March 2021
Sites	1 location across United States

Drugs / interventions tested

Continuous Infusion — full drug profile →
Automated Intermittent Boluses

Conditions studied

Pain, Acute — all drugs for Pain, Acute →
Anesthesia, Local — all drugs for Anesthesia, Local →
Trauma Injury — all drugs for Trauma Injury →

Sponsor

University of California, San Diego

Who can join

18 and older, any sex, with Pain, Acute or Anesthesia, Local. 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.

Average Pain Queried on First Postoperative Day Primary · postoperative day 1

Rated 0-10 on numeric rating scale the average pain from the recovery room until the data collection call. "0" represents no pain and "10" represents worst imaginable pain. Thus, a lower pain score corresponds to less pain.

Group	Value	95% CI
Continuous Infusion	3	1.8 – 4.8
Automated Boluses	0.0	0 – 3.0

Duration of Infusion Primary · 6 days postoperatively

Number of hours from the time the pump is initiated until local anesthetic reservoir exhaustion

Group	Value	95% CI
Continuous Infusion	74	57 – 80
Automated Boluses	119	109 – 125

Worst Pain Secondary · Each of 6 days postoperatively

Rated 0-10 on numeric rating scale. "0" represents no pain and "10" represents worst imaginable pain. Thus, a lower pain score corresponds to less pain.

Day 1

Group	Value	95% CI
Continuous Infusion	5.3	± 3.4
Automated Boluses	3.3	± 3.7

Day 2

Group	Value	95% CI
Continuous Infusion	6.9	± 2.4
Automated Boluses	4.6	± 3.2

Day 3

Group	Value	95% CI
Continuous Infusion	4.9	± 2.7
Automated Boluses	3.6	± 3.0

Day 4

Group	Value	95% CI
Continuous Infusion	6.1	± 2.6
Automated Boluses	3.0	± 3.1

Day 5

Group	Value	95% CI
Continuous Infusion	5.1	± 2.8
Automated Boluses	3.3	± 3.2

Day 6

Group	Value	95% CI
Continuous Infusion	4.3	± 3.2
Automated Boluses	3.7	± 3.0

Average Pain Secondary · Each of 6 days postoperatively

Rated 0-10 on numeric rating scale. "0" represents no pain and "10" represents worst imaginable pain. Thus, a lower pain score corresponds to less pain.

Day 1

Group	Value	95% CI
Continuous Infusion	3.0	± 2.4
Automated Boluses	1.6	± 2.0

Day 2

Group	Value	95% CI
Continuous Infusion	4.1	± 2.0
Automated Boluses	2.0	± 1.8

Day 3

Group	Value	95% CI
Continuous Infusion	3.0	± 2.0
Automated Boluses	1.6	± 1.6

Day 4

Group	Value	95% CI
Continuous Infusion	4.0	± 2.0
Automated Boluses	1.5	± 1.8

Day 5

Group	Value	95% CI
Continuous Infusion	3.1	± 1.7
Automated Boluses	1.7	± 1.8

Day 6

Group	Value	95% CI
Continuous Infusion	2.4	± 2.0
Automated Boluses	1.8	± 1.7

Least Pain Secondary · Each of 6 days postoperatively

Rated 0-10 on numeric rating scale. "0" represents no pain and "10" represents worst imaginable pain. Thus, a lower pain score corresponds to less pain.

Day 1

Group	Value	95% CI
Continuous Infusion	0.2	± 0.8
Automated Boluses	0.1	± 0.5

Day 2

Group	Value	95% CI
Continuous Infusion	1.1	± 1.5
Automated Boluses	0.7	± 1.2

Day 3

Group	Value	95% CI
Continuous Infusion	1.0	± 1.7
Automated Boluses	0.4	± 0.7

Day 4

Group	Value	95% CI
Continuous Infusion	1.8	± 1.8
Automated Boluses	0.5	± 1.1

Day 5

Group	Value	95% CI
Continuous Infusion	1.4	± 1.5
Automated Boluses	0.7	± 1.3

Day 6

Group	Value	95% CI
Continuous Infusion	1.2	± 1.5
Automated Boluses	0.8	± 1.4

Current Pain Secondary · Each of 6 days postoperatively

Rated 0-10 on numeric rating scale. "0" represents no pain and "10" represents worst imaginable pain. Thus, a lower pain score corresponds to less pain.

Day 1

Group	Value	95% CI
Continuous Infusion	2.8	± 2.8
Automated Boluses	1.7	± 2.5

Day 2

Group	Value	95% CI
Continuous Infusion	2.4	± 2.3
Automated Boluses	1.6	± 2.0

Day 3

Group	Value	95% CI
Continuous Infusion	1.9	± 2.0
Automated Boluses	1.2	± 1.4

Day 4

Group	Value	95% CI
Continuous Infusion	2.9	± 2.2
Automated Boluses	1.4	± 2.0

Day 5

Group	Value	95% CI
Continuous Infusion	2.0	± 1.9
Automated Boluses	1.9	± 2.3

Day 6

Group	Value	95% CI
Continuous Infusion	2.1	± 2.1
Automated Boluses	1.9	± 2.1

Opioid Consumption Secondary · Each of 6 days postoperatively

Cumulative opioid consumption during the first 6 days postoperatively

Day 1

Group	Value	95% CI
Continuous Infusion	1.4	± 1.6
Automated Boluses	0.7	± 1.2

Day 2

Group	Value	95% CI
Continuous Infusion	2.0	± 1.9
Automated Boluses	0.9	± 1.3

Day 3

Group	Value	95% CI
Continuous Infusion	1.7	± 1.7
Automated Boluses	0.7	± 1.4

Day 4

Group	Value	95% CI
Continuous Infusion	2.3	± 1.9
Automated Boluses	0.5	± 1.3

Day 5

Group	Value	95% CI
Continuous Infusion	1.3	± 1.5
Automated Boluses	0.5	± 1.2

Day 6

Group	Value	95% CI
Continuous Infusion	0.8	± 1.7
Automated Boluses	0.5	± 1.2

Sleep Disturbances Due to Pain Secondary · Each of 6 nights postoperatively

Number of awakenings due to pain during the first 6 nights postoperatively

Day 1

Group	Value	95% CI
Continuous Infusion	1.0	± 1.2
Automated Boluses	0.4	± 0.7

Day 2

Group	Value	95% CI
Continuous Infusion	1.5	± 1.6
Automated Boluses	0.5	± 1.0

Day 3

Group	Value	95% CI
Continuous Infusion	0.8	± 1.5
Automated Boluses	0.2	± 0.5

Day 4

Group	Value	95% CI
Continuous Infusion	1.5	± 1.6
Automated Boluses	0.2	± 0.5

Day 5

Group	Value	95% CI
Continuous Infusion	1.1	± 1.8
Automated Boluses	0.3	± 0.8

Day 6

Group	Value	95% CI
Continuous Infusion	0.8	± 1.5
Automated Boluses	0.4	± 0.5

Numbness in Foot and Ankle Secondary · Each of 6 days postoperatively

Rate 0 = normal to 10 = insensate

Day 1

Group	Value	95% CI
Continuous Infusion	7.5	± 2.8
Automated Boluses	8.9	± 1.8

Day 2

Group	Value	95% CI
Continuous Infusion	5.1	± 3.4
Automated Boluses	7.9	± 1.8

Day 3

Group	Value	95% CI
Continuous Infusion	4.5	± 3.7
Automated Boluses	7.4	± 2.4

Day 4

Group	Value	95% CI
Continuous Infusion	0.6	± 1.8
Automated Boluses	7.2	± 2.8

Day 5

Group	Value	95% CI
Continuous Infusion	0	± 0
Automated Boluses	5.4	± 3.6

Day 6

Group	Value	95% CI
Continuous Infusion	0.0	± 0.0
Automated Boluses	1.5	± 3.2

Sponsor's own description

This will be a randomized comparison of continuous local anesthetic infusion with patient controlled boluses (PCA) to automated boluses with PCA for continuous popliteal sciatic nerve blocks. The goal will be to determine the relationship between method of local anesthetic administration (continuous with PCA initiated at discharge vs. intermittent dosing with PCA with a 5-hour delay) for continuous peripheral nerve block and the resulting pain control and duration of analgesia.

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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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 NCT04458467 (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 Diego
Last refreshed: 30 June 2022

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/NCT04458467.

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

NCT04458467

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Continuous Infusion

Other recruiting trials for Pain, Acute

Other University of California, San Diego trials

Verify against primary sources