Condition or disease | Intervention/treatment | Phase |
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Anesthesia, Spinal | Drug: Chloroprocaine Injection [Clorotekal] Drug: Bupivacaine Hydrochloride 0.75% Injection Solution | Phase 4 |
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 : | July 31, 2022 |
Estimated Study Completion Date : | August 31, 2022 |
Arm | Intervention/treatment |
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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
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Drug: Chloroprocaine Injection [Clorotekal]
1% chloroprocaine Hydrochloride Injection (50 mg/5 mL) for intrathecal use
Other Name: Clorotekal
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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
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Drug: Bupivacaine Hydrochloride 0.75% Injection Solution
0.75% bupivacaine Hydrochloride injection in 8.25% dextrose for intrathecal use
Other Name: Marcaine spinal
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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rachael Penchoen-Lind, BA | 503-494-5553 | penchoen@ohsu.edu |
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 |
Principal Investigator: | Brandon M Togioka, MD | Oregon Health and Science University |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 26, 2019 | ||||||
First Posted Date ICMJE | May 30, 2019 | ||||||
Last Update Posted Date | April 29, 2021 | ||||||
Actual Study Start Date ICMJE | October 24, 2019 | ||||||
Estimated Primary Completion Date | July 31, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Comparison of Clorotekal and Bupivacaine for Short Obstetric Surgery | ||||||
Official Title ICMJE | The Maternal CLIMB Trial: Chloroprocaine to Reduce the Impact of Motor Block on Patient Recovery After Short Obstetric Surgery | ||||||
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:
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:
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | 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
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Condition ICMJE | Anesthesia, Spinal | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
50 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | August 31, 2022 | ||||||
Estimated Primary Completion Date | July 31, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03967288 | ||||||
Other Study ID Numbers ICMJE | IRB#19846 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Brandon M Togioka, Oregon Health and Science University | ||||||
Study Sponsor ICMJE | Oregon Health and Science University | ||||||
Collaborators ICMJE | B. Braun Medical Inc. | ||||||
Investigators ICMJE |
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PRS Account | Oregon Health and Science University | ||||||
Verification Date | April 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |