Last reviewed · How we verify

NCT03781388

ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

Completed Phase 4 Results posted Last updated 17 April 2026
What this trial tests

Phase 4 trial testing Bupivacaine in Obesity, Morbid in 45 participants. Completed in 6 December 2022.

Timeline
1 May 2019
Primary endpoint
6 December 2022
6 December 2022

Quick facts

Lead sponsorDuke University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingtriple
Primary purposetreatment
Enrollment45
Start date1 May 2019
Primary completion6 December 2022
Estimated completion6 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Duke University

Who can join

Adults 18 to 45, female only, with Obesity, Morbid or Spinal Anesthesia. 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.

Number of Participants With Successful Blocks for Induction (Success Induction) Primary · 10 minutes after intrathecal drug administration

Bilateral T6 sensory level to pinprick

GroupValue95% CI
Bupivacaine - 9.75 mg1
Bupivacaine - 10.5 mg3
Bupivacaine - 11.25 mg27
Bupivacaine - 12 mg11
Number of Participants With Successful Blocks for Operation (Success Operation) Primary · during surgery up to 90 minutes after intrathecal injection

Successful initial sensory level without requiring additional epidural anesthetic

GroupValue95% CI
Bupivacaine - 9.75 mg0
Bupivacaine - 10.5 mg2
Bupivacaine - 11.25 mg21
Bupivacaine - 12 mg11
ED90 (90% Effective Dose) of Intrathecal Bupivacaine for Cesarean Delivery Primary · 90 minutes
GroupValue95% CI
Bupivacaine - Optimized Dose11.5611.16 – 11.99

Sponsor's own description

The aim of this study is to determine the ED90 of hyperbaric intrathecal bupivacaine for the super obese population undergoing cesarean section under a combined spinal epidural technique.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The 90% effective dose of intrathecal hyperbaric bupivacaine for Cesarean delivery under combined spinal-epidural anesthesia in parturients with super obesity: an up-down sequential allocation study.
    Tan HS, Fuller ME, Barney EZ, Diomede OI, et al · · 2024 · cited 3× · PMID 38438681 · DOI 10.1007/s12630-024-02705-5

Verify or expand the search:

Other trials of Bupivacaine

Trials testing the same drug.

Other recruiting trials for Obesity, Morbid

Currently open trials in the same condition.

Other Duke University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03781388.

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