Comparison of Clorotekal and Bupivacaine for Short Obstetric Surgery

NCT03967288 | Suspended Phase 4 FDA Drug

• 1 other identifier: IRB#19846
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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..

Conditions

Anesthesia, Spinal

Keywords

Chloroprocaine; Bupivacaine; Motor Block; Anesthesia, Obstetrical

Outcome Measures

Primary Outcomes (1)

• Motor block-interval assessment

  Bromage scale score at 5 minute intervals, since spinal injection. Interval assessment motor block will be defined as the number of 5-minute intervals since completion of spinal injection to achieve a Bromage score or 2 (able to flex knees)

  5 hours

Secondary Outcomes (5)

• Motor block-patient report

  5 hours

• Phase 1 Post-Anesthesia Care Unit time

  8 hours

• Post-Anesthesia Care Unit time (Phase 1 + Phase 2)

  12 hours

• Time to ambulation

  24 hours

• Bladder Catheterization

  24 hours

Other Outcomes (2)

• Opioid consumption

  2 hours

• Peak block sensory level

  1 hour

Study Arms (2)

Chloroprocaine

EXPERIMENTAL

50 mg of 1% spinal chloroprocaine (5 mL) injected into the intrathecal space over approximately 5 seconds once prior to the start of surgery

Drug: Chloroprocaine Injection [Clorotekal]

Bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacaine Hydrochloride 0.75% Injection Solution

Interventions

Chloroprocaine Injection [Clorotekal] DRUG

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

Also known as: Clorotekal

Chloroprocaine

Bupivacaine Hydrochloride 0.75% Injection Solution DRUG

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

Also known as: Marcaine spinal

Bupivacaine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18 years old to 60 years old
• American Society of Anesthesiologists physical status class 1-3
• Undergoing one of the following obstetric procedures: bilateral tubal ligation, external cephalic version, cerclage insertion, cerclage removal, minimally invasive fetal surgery, or evacuation of retained products of conception.

You may not qualify if:

• Refusal of consent
• Multiple gestations
• History of ester local anesthetic or para-aminobenzoic acid allergy
• Height less than 5 feet or greater than 6 feet
• Body mass index less than 18.5 kg/m2 or greater than 45 kg/m2
• Any coagulopathy defined by platelets \< 80k/microliter, International Normalized Ratio \> 1.2, or Partial Thromboplastin Time \> 36 seconds
• Signs of hypovolemia that is not corrected by routine management including hypotension (systolic blood pressure \< 90 mm Hg) at the time of evaluation
• Liver disease including jaundice and ascites, with elevated liver function tests, Aspartate Aminotransferase \> 2x institutional normal, Alanine Aminotransferase \> 2x institutional normal
• Renal disease including history of dialysis, with elevated renal function tests on admission labs, glomerular filtration rate \< 60 ml/min/1.73 m2
• Infection at the site of potential spinal insertion
• Neurologic condition that contraindicates spinal anesthesia, tethered spinal cord or multiple sclerosis
• Known atypical plasma cholinesterase activity
• Other contraindications to receive a spinal anesthetic
• Vulnerable populations including prisoners and decisionally impaired adults

Sponsors & Collaborators

• Oregon Health and Science University: lead
• B. Braun Medical Inc.: collaborator

Study Sites (1)

OHSU Labor and Delivery; Oregon Health and Science University Hospital

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

chloroprocaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Brandon M Togioka, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subject, obstetrical provider, investigator, and outcomes assessor will be blinded. The anesthesia provider will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2019
• First Posted: May 30, 2019
• Study Start: October 24, 2019
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)