Clinical Trial

Medication During Obstetric Procedures

Study Description

Comparison of Clorotekal and Bupivacaine for Short Obstetric Surgery

The following obstetric procedures are commonly performed with spinal anesthesia on labor and delivery: bilateral tubal ligation, external cephalic version, cerclage insertion, cerclage removal, minimally invasive fetal surgery, and evacuation of retained products of conception. Bupivacaine is currently the standard spinal medication for these procedures because of its long history of safe use, its low incidence of transient neurologic symptoms, and its ability to provide a dependable, dense block with a high degree of maternal satisfaction. While bupivacaine has the aforementioned advantages, it unfortunately has a long duration of action, up to 240-380 minutes, which far exceeds the time necessary to complete most obstetric procedures. ClorotekalAR, the first Food and Drug Administration approved chloroprocaine solution created for spinal injection, is a potential alternative. When compared with bupivacaine spinals, chloroprocaine spinals have been shown to facilitate clinically significant shorter times to resolution of motor and sensory block, first ambulation, micturition, and discharge readiness. The objective of this study is to determine if a strategy of spinal anesthesia with chloroprocaine will reduce the duration of motor block, compared with equivalent block with hyperbaric bupivacaine..

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Chloroprocaine Injection [Clorotekal]

1% chloroprocaine Hydrochloride Injection (50 mg/5 mL) for intrathecal use

Drug - Bupivacaine Hydrochloride 0.75% Injection Solution

0.75% bupivacaine Hydrochloride injection in 8.25% dextrose for intrathecal use

Additional Information

Official Study Title

The Maternal CLIMB Trial: Chloroprocaine to Reduce the Impact of Motor Block on Patient Recovery After Short Obstetric Surgery

Clinical Trial ID

NCT03967288

ParticipAid ID

dL9zDe