RecruitingNot ApplicableNCT05233462

Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

Height Adjusted Versus Standardized Dose of Bupivacaine in Spinal Anesthesia for Caesarean Delivery - A Randomized Double-blind Interventional Study

Sponsor

University Hospital, Caen

Enrollment

250 participants

Start Date

Feb 23, 2022

Study Type

INTERVENTIONAL

Conditions

Cesarean Section Complications Regional Anesthesia Morbidity Local Anesthetic Complication

Summary

General anesthesia during pregnancy is associated with several major risks including unanticipated difficult airway, pulmonary aspiration, and specific anesthetic effects on the newborn. Thus, intrathecal anesthesia is the technique of choice for cesarean section. Nevertheless, the main side effect of intrathecal anesthesia is arterial hypotension which depend mainly on the dose of local anesthetic administered intrathecally. To date there is no guidelines nor evidences whic help the anesthetist to precisely estimate the required dose. Most often a "standardized dose" of 8 to 10 mg of bupivacaine is administered. However, some data suggest that a lower dose may be administered resulting in less frequent arterial hypotension. Nevertheless, a well designed randomized study is lacking.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two ways of dosing spinal anesthesia for planned cesarean sections: a standard fixed dose versus a dose adjusted for the patient's height. The goal is to find out if height-adjusted dosing causes less drop in blood pressure during surgery. You may be eligible if... - You are pregnant and scheduled for a planned (elective) cesarean section - You are at least 35 weeks pregnant - You are having spinal (intrathecal) anesthesia for your C-section - You are between 18 and 45 years old and have signed informed consent You may NOT be eligible if... - Your cesarean section is unplanned or an emergency - You have a medical reason why spinal anesthesia is not safe for you - You are taking blood pressure medications during pregnancy to control hypertension - You have pre-eclampsia or eclampsia - You have been diagnosed with Marfan syndrome or Ehlers Danlos disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERstandardized dose

intrathecal anesthesia with 10 mg of bupivacaine

OTHERadjusted dose

intrathecal anesthesia with 0.05 mg of bupivacaine par cm of patient's height

Locations(1)

Caen University Hospital

Caen, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05233462

Related Trials

Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section

NCT053805314 locations

Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial

NCT072846151 location