ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

NCT03781388 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00101530
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Delivery; Obesity, Morbid; Spinal Anesthesia

Keywords

Bupivacaine ED90; Cesarean Delivery; Obesity; Spinal Anesthesia

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Successful Blocks for Induction (Success Induction)

  Bilateral T6 sensory level to pinprick

  10 minutes after intrathecal drug administration

• Number of Participants With Successful Blocks for Operation (Success Operation)

  Successful initial sensory level without requiring additional epidural anesthetic

  during surgery up to 90 minutes after intrathecal injection

• ED90 (90% Effective Dose) of Intrathecal Bupivacaine for Cesarean Delivery

  90 minutes

Study Arms (2)

Starting dose of Bupivacaine (9.75 mg)

EXPERIMENTAL

The starting dose of hyperbaric bupivacaine for the first patient in this study will be 9.75mg; the dose for the subsequent subject will be based on the response of the preceding subject as per the Narayana Rule, a modification of the biased-coin design (BCD) up-down sequential method (UDM).

Drug: Bupivacaine

Subsequent dose

EXPERIMENTAL

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

Determination of the dose will rely on the outcomes of the preceding 7 patients receiving the same dose, as the number of previous patients to consider is a function of the target dose. Among all patients who received a certain dose, a proportion of successful outcomes will be determined (P(d)); if P(d) \<0.90, and at least one of the previous 7 patients who received the same dose had an unsatisfactory outcome, the next patient will receive a pre-determined increment of 0.75 mg of bupivacaine. Alternatively, if P(d) 0.90 and the previous 7 patients who received the same dose had successful outcomes, the next patient will receive a pre-determined decrement of 0.75mg of bupivacaine. Otherwise, the dose will remain the same.

Starting dose of Bupivacaine (9.75 mg); Subsequent dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiology (ASA) class 2 and 3
• English speaking
• Gestational age \> 36 weeks
• Scheduled for cesarean delivery under combined spinal epidural anesthesia
• years or older
• BMI \> 50 kg/m2

You may not qualify if:

• History of past or current intravenous drug or chronic opioid abuse
• Allergy or contraindication to any study medications
• Intrapartum cesarean delivery under epidural anesthesia
• Cesarean delivery under general anesthesia

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Tan HS, Fuller ME, Barney EZ, Diomede OI, Landreth RA, Pham T, Rubright SM, Ernst L, Habib AS. 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. Can J Anaesth. 2024 May;71(5):570-578. doi: 10.1007/s12630-024-02705-5. Epub 2024 Mar 4.

  PMID: 38438681 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Ashraf Habib
• Organization: Duke University School of Medicine

ashraf.habib@duke.edu

9196682024

Study Officials

• Ashraf S Habib, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Blinded study drugs will be prepared by an anesthesia provider not involved in the study. The anesthesia provider providing care to the patient will be blinded to the dosage of the hyperbaric bupivacaine. In order to preserve the blinding of the provider, the total volume of study drug will be maintained at a constant of 2.05mL. The difference in total volume based on the variation of hyperbaric bupivacaine dosing will be replaced with preservative free normal saline.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The starting dose of hyperbaric bupivacaine for the first patient in this study will be 9mg; the dose for the subsequent subject will be based on the response of the preceding subject as per the Narayana Rule, a modification of the biased-coin design (BCD) up-down sequential method (UDM).

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 19, 2018
• Study Start: May 1, 2019
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)