Clinical trial

Predicting Spinal Failure With Blunt Needle Pinprick Sensory Testing

NCT06206044

Name

25364

Description

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.

Trial arms

Trial start

2024-01-08

Estimated PCD

2025-12-31

Trial end

2026-01-31

Treatment

Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphine

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.

Arms:

Study Cohort

Other names:

Marcaine

Size

250

Primary endpoint

Number of participants with spinal failure

2 Hours

Eligibility criteria

Inclusion Criteria: * Patients undergoing cesarean delivery under spinal or combined spinal epidural anesthesia * BMI between 20 and 40 kg/m2 * Height between 5 feet 2 inches and 5 feet 10 inches. * English and non-English speaking patients, if interpretive services are available Exclusion Criteria: * Patient refusal * Contraindications to neuraxial anesthesia (coagulopathy, CNS pathology, infection at site of needle puncture) * Allergy to any study medications * Use of epidural anesthesia * Emergency (red) cesarean delivery * Conditions that impact dermatomal sensory testing including spinal cord injury with sensory deficits and abdominoplasty * Prison inmates * Decisionally impaired individuals * Pregnancies involving multiple fetuses

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 250, 'type': 'ESTIMATED'}}

Updated at

2024-01-18

1 organization

1 product

3 indications

Organization

Oregon Health and Science University

Product

Intrathecal 1.6 ml 0.75% bupivacaine in 8.25% dextrose combined with 15 mcg fentanyl and 150 mcg preservative-free morphine

Indication

c-section

Indication

Anesthesia

Indication

Obstetric