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Super obese moms: study finds ideal spinal anesthesia dose for safer C-Sections

NCT ID NCT03781388

Symptom relief Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to find the right dose of a spinal anesthesia drug (bupivacaine) for women with a BMI over 50 undergoing a planned C-section. Researchers tested different doses in 45 women to see which dose worked best without needing extra pain relief. The goal is to improve safety and effectiveness of anesthesia in this specific group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bupivacaine
What this could lead to
If successful, this could help doctors give just the right amount of spinal anesthesia for super obese women having a C-section, improving safety and comfort.
What could go wrong
This is a small, completed Phase 4 trial with only 45 participants. The results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

45 people

The number who actually took part.

Started

May 2019

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

morbid obesity Obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cesarean delivery Obesity, morbid Spinal anesthesia

Contacts and locations

Locations

  • Duke University Hospital

    Durham, North Carolina, 27705, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.