Adverse Reaction to Spinal Anesthetic, Maternal Care for Cervical Incompetence
Conditions
Keywords
Chloroprocaine, cervical cerclage, spinal anesthesia, Bupivacaine
Brief summary
This study aims to determine whether or not spinal anesthesia with the local anesthetic drug, chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in faster discharge from the post-anesthesia care unit after surgery.
Detailed description
This will be a prospective, randomized, double blind clinical trial. Subjects will be ASA I and II women ≥18 yrs old with a singleton pregnancy in the 1st or 2nd trimester of pregnancy undergoing cervical cerclage with spinal anesthesia. Patients will be randomly allocated to the chloroprocaine (CP) or bupivacaine group (BUP). Patients will receive spinal anesthesia with either chloroprocaine 50 mg with fentanyl 15 mcg or bupivacaine 9 mg with fentanyl 15 mcg. Bupivacaine is the most common local anesthetic used for cervical cerclage with spinal anesthesia. Bupivacaine is safe and has been preferred over other medications such as lidocaine, because it is associated with a low incidence of a complication from spinal anesthesia known as transient neurologic symptoms - a condition where pain and cramping in the buttocks and lower extremities can be experienced for several days. Bupivacaine is a long-acting local anesthetic agent and therefore has the disadvantage of a prolonged anesthetic recovery that may last a few hours. Chloroprocaine is a local anesthetic with a fast onset and short duration that may be used for spinal anesthesia for ambulatory procedures. Chloroprocaine is currently used at the research institution for spinal anesthesia for ambulatory surgical patients, especially for lower extremity orthopedic procedures such as knee arthroscopy, as well as for pregnant patients.
Interventions
DRUGChloroprocaine
Administered as a single injection or continuously through an indwelling catheter - 50 mg
DRUGBupivacaine
A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)
DRUGFentanyl
15 mcg Fentanyl will be included int he spinal anesthetic in both groups
DRUGSaline
Preservative free normal saline (0.3 ml) to bring the volume to \ 2 ml
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ASA I and II women * 18-45 yrs old * Singleton pregnancy * Cervical cerclage 1st or 2nd trimester of pregnancy undergoing with spinal anesthesia * Height 150 - 180 cm * BMI ≤ 40 kg/m2.
Exclusion criteria
* Any contraindication to neuraxial anesthesia (history of neurologic disease (e.g., multiple sclerosis, spinal stenosis, central or peripheral neuropathy) * Pre-existing/chronic back pain * Ester local anesthetic allergy, PABA allergy * History of atypical cholinesterase (CP is metabolized by cholinesterase)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Resolution of Motor Block | 3 hours | The mean difference between groups in time between the end of spinal injection (t IT) to time for no motor block (t motor), i.e. tIT - T motor. Motor block will be assessed using the Bromage scale: Bromage Scale I = free movement of the legs and feet = no block II = able to flex knees, with free movement of feet = partial (33%) block III = unable to flex knees, but with free movement of the feet = almost complete (66%) block IV = unable to move legs or feet = complete block (100%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Ambulate | 5 hours | Time from spinal anesthesia placement to ability to ambulate. |
| Time to Void | 5 hours | Time from spinal anesthesia injection to ability to void spontaneously. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chloroprocaine (CP) Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)
Chloroprocaine: Administered as a single injection or continuously through an indwelling catheter - 50 mg
Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups | 23 |
| Bupivacaine (BUP) Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to \
2 ml
Bupivacaine: A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)
Fentanyl: 15 mcg Fentanyl will be included int he spinal anesthetic in both groups
Saline: Preservative free normal saline (0.3 ml) to bring the volume to \
2 ml | 20 |
| Total | 43 |
Baseline characteristics
| Characteristic | Chloroprocaine (CP) | Total | Bupivacaine (BUP) |
|---|---|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 4 | 33 years STANDARD_DEVIATION 5 | 34 years STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 16 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 26 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 21 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 7 Participants | 16 Participants | 9 Participants |
| Region of Enrollment United States | 23 Participants | 43 Participants | 20 Participants |
| Sex: Female, Male Female | 23 Participants | 43 Participants | 20 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 / 23 | 0 / 20 |
| other Total, other adverse events | 0 / 23 | 0 / 20 |
| serious Total, serious adverse events | 0 / 23 | 0 / 20 |
Outcome results
Primary
Time to Resolution of Motor Block
The mean difference between groups in time between the end of spinal injection (t IT) to time for no motor block (t motor), i.e. tIT - T motor. Motor block will be assessed using the Bromage scale: Bromage Scale I = free movement of the legs and feet = no block II = able to flex knees, with free movement of feet = partial (33%) block III = unable to flex knees, but with free movement of the feet = almost complete (66%) block IV = unable to move legs or feet = complete block (100%)
Time frame: 3 hours
Population: One protocol violation in the chloroprocaine group led to 22 subjects being analyzed. One block failure in the bupivacaine group led to 19 subjects being analyzed. During analysis it was noted that the motor and sensory block resolution data was missing for 2 subjects in the bupivacaine group so only partial data was available. As a result, 17 participants were analyzed in the bupivacaine group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chloroprocaine (CP) | Time to Resolution of Motor Block | 109 minutes |
| Bupivacaine (BUP) | Time to Resolution of Motor Block | 112 minutes |
Secondary
Time to Ambulate
Time from spinal anesthesia placement to ability to ambulate.
Time frame: 5 hours
Population: One protocol violation in the chloroprocaine group led to 22 subjects being analyzed. One block failure in the bupivacaine group led to 19 subjects being analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chloroprocaine (CP) | Time to Ambulate | 158 minutes |
| Bupivacaine (BUP) | Time to Ambulate | 229 minutes |
Secondary
Time to Void
Time from spinal anesthesia injection to ability to void spontaneously.
Time frame: 5 hours
Population: In practice, time to void coincided with time to ambulate (to use toilet) and the data is therefore identical to time to ambulate (also time to meet discharge criteria in practice). One protocol violation in the chloroprocaine group led to 22 subjects being analyzed. One block failure in the bupivacaine group led to 19 subjects being analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chloroprocaine (CP) | Time to Void | 229 minutes |
| Bupivacaine (BUP) | Time to Void | 158 minutes |