Cervical Incompetence
Conditions
Keywords
Cervical Cerclage, Bupivacaine, Chloroprocaine, spinal anesthesia
Brief summary
This study aims to compare the effect of chloroprocaine vs. bupivacaine on duration of motor block and duration until meeting discharge criteria in patients undergoing cervical cerclage. The hypothesis is that chloroprocaine will result in faster resolution of motor block.
Detailed description
Cervical cerclage is an ambulatory surgical procedure of short duration commonly performed under spinal anesthesia. Bupivaciane and chlororpocaine are both commonly used, but how their use impacts clinical care, in particular patient flow, is not well studied. This is a prospective, randomized, double blind, controlled trial. Participants meeting inclusion criteria will be randomly allocated to receive spinal anesthesia with either chloroprocaine or bupivacaine. Patients will then be assessed for motor block and sensory level until they are discharged from the recovery room.
Interventions
DRUGChloroprocaine
The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug. During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.
DRUGBupivacaine
The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug. During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.
Sponsors
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The anesthesia provider responsible for the clinical care of the patient will be given an envelope prepared during randomization and instructed to open it and prepare the medication in a separate room, such that the investigator and patient cannot see which vial is being used to prepare the medication. The anesthesia provider will also be instructed not to reveal the allocation group to the investigator or the patient. Both bupivacaine and chloroprocaine are clear liquids, and the intended doses of both medications are the same volume, to insure complete blinding.
Intervention model description
Prospective, randomized, double blinded clinical trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* ASA classification II or III females * Age: 18-45 years old * BMI ≤ 50 kg/m2 * Singleton pregnancy * Simple prophylactic cervical cerclage * Planning neuraxial anesthesia
Exclusion criteria
* Abdominal and complex cervical cerclage (e.g. bulging bag) * Contraindication to neuraxial anesthesia * Known hypersensitivity to chloroprocaine (a.k.a. Ester allergy), paraaminobenzoic acid (PABA) or bupivacaine (a.k.a. Amide allergy) * Pseudocholinesterase deficiency * Concomitant use with ergot-type oxytocic drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Motor Block | 6 hours | The time difference between local anesthetic injection and complete resolution of motor block -as measured on the Bromage scale: I = free movement of feet, legs and hip = No block II = able to flex knees, with free movement of feet = Mild block III = unable to flex knees, but with free movement of feet = Moderate block IV = unable to move legs or feet = Complete block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Ambulation | 6 hours | The time difference between local anesthetic injection and patient's walking for the first time postoperatively. |
| Time to Micturation | 6 hours | The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively. |
| Duration of Sensory Block | 6 hours | The time difference between local anesthetic injection and complete resolution of sensory block. The sensory level was tested using a blunt needle tip along the patient's demratomal distribution of the spinal anesthetic. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chloroprocaine Patients assigned to chlorprocaine will receive a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)
Chloroprocaine: The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia. | 5 |
| Bupivacaine Patients assigned to bupivacaine will receive a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).
Bupivacaine: The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia. | 5 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Bupivacaine | Total | Chloroprocaine |
|---|---|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 3.8 | 31 years STANDARD_DEVIATION 4.5 | 33 years STANDARD_DEVIATION 4.5 |
| ASA | 2 Scores on a scale STANDARD_DEVIATION 0 | 2.1 Scores on a scale STANDARD_DEVIATION 0.38 | 2.3 Scores on a scale STANDARD_DEVIATION 0.58 |
| BMI | 29.7 Kg/m^2 STANDARD_DEVIATION 5.9 | 30 Kg/m^2 STANDARD_DEVIATION 5.4 | 30.4 Kg/m^2 STANDARD_DEVIATION 5.9 |
| Gestational age | 14.8 weeks STANDARD_DEVIATION 3.7 | 15.4 weeks STANDARD_DEVIATION 3.7 | 16 weeks STANDARD_DEVIATION 3.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Duration of Motor Block
The time difference between local anesthetic injection and complete resolution of motor block -as measured on the Bromage scale: I = free movement of feet, legs and hip = No block II = able to flex knees, with free movement of feet = Mild block III = unable to flex knees, but with free movement of feet = Moderate block IV = unable to move legs or feet = Complete block
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chloroprocaine | Duration of Motor Block | 75 minutes | Standard Deviation 5.7 |
| Bupivacaine | Duration of Motor Block | 99 minutes | Standard Deviation 48 |
Secondary
Duration of Sensory Block
The time difference between local anesthetic injection and complete resolution of sensory block. The sensory level was tested using a blunt needle tip along the patient's demratomal distribution of the spinal anesthetic.
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chloroprocaine | Duration of Sensory Block | 127 minutes | Standard Deviation 20.6 |
| Bupivacaine | Duration of Sensory Block | 210 minutes | Standard Deviation 56.1 |
Secondary
Time to Ambulation
The time difference between local anesthetic injection and patient's walking for the first time postoperatively.
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chloroprocaine | Time to Ambulation | 110 minutes | Standard Deviation 1.4 |
| Bupivacaine | Time to Ambulation | 179 minutes | Standard Deviation 2.6 |
Secondary
Time to Micturation
The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chloroprocaine | Time to Micturation | 111 minutes | Standard Deviation 1.3 |
| Bupivacaine | Time to Micturation | 233 minutes | Standard Deviation 1.7 |