ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

NCT ID: NCT03781388

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-12-06

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

Obesity, Morbid; Spinal Anesthesia; Cesarean Delivery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Starting dose of Bupivacaine (9 mg)

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).

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: 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.

Subsequent dose

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: 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.

Interventions

Bupivacaine

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashraf S Habib, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Hospital

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38438681 (View on PubMed)

Other Identifiers

Pro00101530

Identifier Type: -

Identifier Source: org_study_id