The Maternal CLIMB Trial: Chloroprocaine to Reduce the Impact of Motor Block on Patient Recovery After Short Obstetric Surgery
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.
Condition:
Anesthesia, Spinal
Treatment:
Chloroprocaine Injection [Clorotekal]
Start Date:
October 24, 2019
Sponsor:
Oregon Health and Science University
For More Information:
https://clinicaltrials.gov/show/NCT03967288