Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

Recruiting now · Not applicable

Conditions studied: Regional Anesthesia Morbidity, Cesarean Section Complications, Local Anesthetic Complication

In brief

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.

Key facts

Study ID

NCT05233462

Run by

University Hospital, Caen

People needed

250

Starts

2022-02-23

Expected to finish

2026-12-31

Last updated by the study team

2025-07-25

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• scheduled cesarean section with intrathecal anesthesia
• term pregnancy > 35 weeks
• signed informed consent

You may not qualify if…

• unscheduled or emergent cesarean section
• any contra indication to intrathecal anesthesia
• any antihypertensive drug prescribed to control arterial pressure during pregnancy
• pre-eclampsia and eclampsia
• history of Marfan or Ehlers Danlos disease

Where it is running

• Caen University Hospital — Caen, France (enrolling)

Full record on ClinicalTrials.gov

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