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Comparison of Clorotekal and Bupivacaine for Short Obstetric Surgery (CLIMB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03967288
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : March 5, 2020
Sponsor:
Collaborator:
B. Braun Medical Inc.
Information provided by (Responsible Party):
Brandon Togioka, Oregon Health and Science University

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..

Condition or disease Intervention/treatment Phase
Anesthesia, Spinal Drug: Chloroprocaine Injection [Clorotekal] Drug: Bupivacaine Hydrochloride 0.75% Injection Solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The subject, obstetrical provider, investigator, and outcomes assessor will be blinded. The anesthesia provider will be unblinded.
Primary Purpose: Treatment
Official Title: The Maternal CLIMB Trial: Chloroprocaine to Reduce the Impact of Motor Block on Patient Recovery After Short Obstetric Surgery
Actual Study Start Date : October 24, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Chloroprocaine Injection [Clorotekal]
1% chloroprocaine Hydrochloride Injection (50 mg/5 mL) for intrathecal use
Other Name: Clorotekal

Active Comparator: 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
Drug: Bupivacaine Hydrochloride 0.75% Injection Solution
0.75% bupivacaine Hydrochloride injection in 8.25% dextrose for intrathecal use
Other Name: Marcaine spinal




Primary Outcome Measures :
  1. Motor block-interval assessment [ Time Frame: 5 hours ]
    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)


Secondary Outcome Measures :
  1. Motor block-patient report [ Time Frame: 5 hours ]
    The patient will be instructed to notify the outcomes assessor when they are able to flex their knees (Bromage score 2). Patient report motor block will be defined as the time interval in minutes since completion of spinal injection to achieve a Bromage score of 2 (able to flex knees).

  2. Phase 1 Post-Anesthesia Care Unit time [ Time Frame: 8 hours ]
    Phase 1 Post-Anesthesia Care Unit time will be defined as the interval between "out of operating room" and "end of Phase 1" as documented by the Post-Anesthesia Care Unit nurse.

  3. Post-Anesthesia Care Unit time (Phase 1 + Phase 2) [ Time Frame: 12 hours ]
    Post-Anesthesia Care Unit time will be defined as the interval between "out of operating room" and "end of Phase 2" as documented by the labor and delivery nurse for patients discharged home and as mutually agreed upon by the outcomes assessor and nurse for patients discharged to the ward. In addition to meeting Phase 1 criteria, patients must be able to ambulate, micturate, and tolerate food intake in order to exit Phase 2 of Post-Anesthesia Care Unit recovery. Completing Phase 2 of Post-Anesthesia Care Unit recovery is also requires that a responsible adult can escort the patient out of the hospital and remain with the patient for the first 24 hours.

  4. Time to ambulation [ Time Frame: 24 hours ]
    Defined as the time interval in minutes between intrathecal medication administration and time to first ambulation. Ambulation requires a Bromage score of 1 and a standard nursing assessment that is already in practice at Oregon Health and Science University (OHSU).

  5. Bladder Catheterization [ Time Frame: 24 hours ]
    Defined as inserting either a Foley or Straight catheter into the bladder


Other Outcome Measures:
  1. Opioid consumption [ Time Frame: 2 hours ]
    Defined as the total intraoperative opioid consumption in milligram morphine equivalents.

  2. Peak block sensory level [ Time Frame: 1 hour ]
    Defined as the most caudal dermatome with sensation to pinprick at the time of "anesthesia ready."



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967288


Contacts
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Contact: Rachael Penchoen-Lind, BA 503-494-5553 penchoen@ohsu.edu

Locations
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United States, Oregon
OHSU Labor and Delivery; Oregon Health and Science University Hospital Recruiting
Portland, Oregon, United States, 97239
Contact: Brandon M Togioka, MD    503-494-4572    togioka@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
B. Braun Medical Inc.
Investigators
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Principal Investigator: Brandon M Togioka, MD Oregon Health and Science University
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Responsible Party: Brandon Togioka, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03967288    
Other Study ID Numbers: IRB#19846
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Brandon Togioka, Oregon Health and Science University:
Chloroprocaine
Bupivacaine
Motor Block
Anesthesia, Obstetrical
Additional relevant MeSH terms:
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Bupivacaine
Chloroprocaine
Procaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents