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Local Anesthetic

Chloroprocaine Injection [Clorotekal] for Spinal Anesthesia (CLIMB Trial)

Phase 4
Waitlist Available
Led By Brandon M Togioka, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 10 Other Conditions
No Placebo-Only Group
Drug Has Already Been Approved

Summary

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. Clorotekal®, 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..

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Motor block-interval assessment
Secondary study objectives
Bladder Catheterization
Motor block-patient report
Phase 1 Post-Anesthesia Care Unit time
+2 more
Other study objectives
Opioid consumption
Peak block sensory level

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ChloroprocaineExperimental Treatment1 Intervention
50 mg of 1% spinal chloroprocaine (5 mL) injected into the intrathecal space over approximately 5 seconds once prior to the start of surgery
Group II: BupivacaineActive Control1 Intervention
10.5 mg of spinal hyperbaric bupivacaine (1.4 mL of 0.75% bupivacaine hydrochloride in 8.25% dextrose) injected into the intrathecal space over approximately 5 seconds once prior to the start of surgery

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,006 Previous Clinical Trials
7,413,892 Total Patients Enrolled
B. Braun Medical Inc.Industry Sponsor
17 Previous Clinical Trials
571 Total Patients Enrolled
Brandon M Togioka, MDPrincipal Investigator - Oregon Health and Science University
Oregon Health and Science University
7 Previous Clinical Trials
1,025 Total Patients Enrolled
~3 spots leftby Jun 2025