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
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia, Spinal||Drug: Chloroprocaine Injection [Clorotekal] Drug: Bupivacaine Hydrochloride 0.75% Injection Solution||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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.|
|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|
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
- 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)
- 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).
- 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.
- 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.
- 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).
- Bladder Catheterization [ Time Frame: 24 hours ]Defined as inserting either a Foley or Straight catheter into the bladder
- Opioid consumption [ Time Frame: 2 hours ]Defined as the total intraoperative opioid consumption in milligram morphine equivalents.
- Peak block sensory level [ Time Frame: 1 hour ]Defined as the most caudal dermatome with sensation to pinprick at the time of "anesthesia ready."
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
|Contact: Rachael Penchoen-Lind, BAfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Brandon M Togioka, MD||Oregon Health and Science University|