Comparison of Clorotekal and Bupivacaine for Short Obstetric Surgery

NCT ID: NCT03967288

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-24
• Study Completion Date: 2025-12-31

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..

Detailed Description

This will be a single-blind, randomized, controlled, single center clinical trial assessing the efficacy of spinal chloroprocaine on resolution of motor block and associated patient flow through the post-anesthesia care unit . Fifty patients will be equally randomized to receive either spinal chloroprocaine or hyperbaric bupivacaine.

Masking:

1. Subject

2. Obstetric provider

3. Investigator

4. Outcomes assessor

The anesthesia provider will be unblinded.

Subjects will be allocated to either intrathecal injection of 50 mg of 1% chloroprocaine or 10.5 mg (1.4 mL) of 0.75% hyperbaric bupivacaine. The intrathecal space will be accessed with a 25 gauge Whitacre needle. Upon obtaining cerebrospinal fluid, the syringe of study solution will be attached the end of the Whitacre needle. The syringe will be pulled back to reveal aspiration of cerebrospinal fluid. The study solution will then be administered over approximately 5 seconds. The Whitacre needle and spinal introducer needle will be removed from the patient's back. The patient will be placed supine on the operating room table. The outcomes assessor will then be allowed to enter the operating room.

Decisions on when to administer additional sedative and analgesic medications will be left to the discretion of the anesthesia team. The level of block will be initially assessed by the anesthesia team. When the block is felt to be at peak height the outcomes assessor will test with pinprick to determine the peak block height.

In accordance with standard of practice at our institution all patients will have convective warmers used during the case and patient temperature will be monitored. Non-invasive blood pressures will be obtained every 2.5 minutes after spinal placement. The frequency of blood pressure measurement will be changed to every 5 minutes, 15 minutes after spinal placement. Anesthesia providers will administer phenylephrine via intravenous bolus to maintain maternal blood pressure within 20% of baseline or for a systolic blood pressure < 100 mm Hg. Anesthesia providers will be allowed to add ephedrine or glycopyrrolate to phenylephrine for maternal hypotension with co-existent bradycardia.

A research coordinator will remain with the patient throughout their time in the operating room and the post-anesthesia care unit. Active, non-standard of care, monitoring for the following signs and symptoms of local anesthetic toxicity will occur in the operating room and post-anesthesia care unit at the following time intervals after spinal placement: 5 minutes, 10 minutes, 15 minutes, upon post-anesthesia care unit arrival, upon completing Phase 1 of post-anesthesia care unit recovery, and upon discharge from the post-anesthesia care unit:

• Seizures
• Tinnitus
• Metallic taste
• Agitation
• Sedation
• Respiratory depression (respiratory rate < 10 breaths per minute)
• Dizziness
• Nausea
• Vomiting
• Vision changes
• Paresthesia
• Perioral numbness
• Hypotension (drop in mean arterial pressure > 20% or systolic blood pressure < 100 mm Hg)
• Arrhythmias

The research coordinator will obtain from anesthesia, upon arrival to the post-anesthesia care unit, the total dose of intraoperative opioids administered, whether the patient had intraoperative hypotension, and the total dose of intraoperative phenylephrine administered. In the post-anesthesia care unit, the research coordinator will determine the patient's Bromage scale score at 5-minute increments. The research coordinator will also ask the patient to notify them when they have a Bromage scale score of 2 (able to flex knees). While in the post-anesthesia care unit, the research coordinator will also document the time of post-anesthesia care unit arrival, the end of Phase 1 of post-anesthesia care unit recovery, and the time that the patient leaves the post-anesthesia care unit (end of Phase 2).

The research coordinator will meet with the patient on the evening of their surgery as well as daily for the duration of their hospitalization to assess for time of first ambulation, bladder catheterization, and for adverse events including, new postoperative neurologic deficits and any other potential adverse events.

To gather information on the incidence of new postoperative neurologic deficits all patients will be called 1 week after spinal insertion. A telephone script will be used to obtain this information.

Conditions

Anesthesia, Spinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Chloroprocaine

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 Type: EXPERIMENTAL

Chloroprocaine Injection [Clorotekal]

Intervention Type: DRUG

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

Bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride 0.75% Injection Solution

Intervention Type: DRUG

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

Interventions

Chloroprocaine Injection [Clorotekal]

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

Intervention Type: DRUG

Bupivacaine Hydrochloride 0.75% Injection Solution

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

Intervention Type: DRUG

Other Intervention Names

Clorotekal; Marcaine spinal

Eligibility Criteria

Inclusion Criteria

1. Women 18 years old to 60 years old

2. American Society of Anesthesiologists physical status class 1-3

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.

Exclusion Criteria

1. Refusal of consent

2. Multiple gestations

3. History of ester local anesthetic or para-aminobenzoic acid allergy

4. Height less than 5 feet or greater than 6 feet

5. Body mass index less than 18.5 kg/m2 or greater than 45 kg/m2

6. Any coagulopathy defined by platelets < 80k/microliter, International Normalized Ratio > 1.2, or Partial Thromboplastin Time > 36 seconds

7. Signs of hypovolemia that is not corrected by routine management including hypotension (systolic blood pressure < 90 mm Hg) at the time of evaluation

8. Liver disease including jaundice and ascites, with elevated liver function tests, Aspartate Aminotransferase > 2x institutional normal, Alanine Aminotransferase > 2x institutional normal

9. Renal disease including history of dialysis, with elevated renal function tests on admission labs, glomerular filtration rate < 60 ml/min/1.73 m2

10. Infection at the site of potential spinal insertion

11. Neurologic condition that contraindicates spinal anesthesia, tethered spinal cord or multiple sclerosis

12. Known atypical plasma cholinesterase activity

13. Other contraindications to receive a spinal anesthetic

14. Vulnerable populations including prisoners and decisionally impaired adults

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

B. Braun Medical Inc.

INDUSTRY

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Brandon M Togioka

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brandon M Togioka, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

OHSU Labor and Delivery; Oregon Health and Science University Hospital

Portland, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB#19846

Identifier Type: -

Identifier Source: org_study_id