Evaluation of the Typical Spinal Block During Cesarean Delivery

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT06206044
Status
Enrolling By Invitation

Conditions

  • Anesthesia, Obstetric
  • Cesarean Section

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphine — DRUG
    Patients will receive standard intrathecal medications for urgent and scheduled cesarean delivery at the study site. All study subjects will receive bupivacaine, fentanyl, and morphine.

Study Details

This will be a prospective, observational, single-center study to evaluate the accuracy of sensory testing by blunt 16-gauge plastic cannula during the 15 minutes after spinal injection for predicting spinal failure. While previous studies assessed the minimal sensory level required for painless cesarean delivery at skin incision or delivery, no studies have assessed the accuracy of sensory testing at an earlier time point.

Key Dates

Start date
Jun 10, 2024
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Study Cohort
    Healthy pregnant women of BMI between 20 and 40 kg/m2, height between 5 feet 2 inches and 5 feet 10 inches, who are having cesarean delivery under spinal or combined spinal epidural anesthesia.

Primary Outcome Measure

Number of participants with spinal failure [ Time Frame: 90 minutes ]

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health and Science UniversityPortlandOregon97239-

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By research site
Oregon Health and Science University· Portland, OR

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