A Phase 4 interventional study of Chloroprocaine and Bupivacaine in Cervical Incompetence, sponsored by Tufts Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-08-25.
Sponsored by Tufts Medical Center · Phase 4, Interventional, and Treatment
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.
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.
37 studies on the registry are indexed under Uterine Cervical Incompetence; 11 are open to participants now.
This study's enrollment of 10 is below the median of 70 across 22 interventional studies indexed under Uterine Cervical Incompetence.
Browse Uterine Cervical Incompetence studies →Tufts Medical Center is the lead sponsor of 200 studies on the registry; 28 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 16 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: Chloroprocaine
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).
Drug: 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.
Also known as: Sensorcaine
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.
Also known as: Marcaine
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
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
Time to Ambulation
The time difference between local anesthetic injection and patient's walking for the first time postoperatively.
Time frame: 6 hours
Time to Micturation
The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.
Time frame: 6 hours
| Milestone | Chloroprocaine | Bupivacaine |
|---|---|---|
| Started | 5 | 5 |
| Completed | 4 | 5 |
| Not completed | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
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
| minutes | Chloroprocaine | Bupivacaine |
|---|---|---|
| Duration of Motor Block | 75 ± 5.7 | 99 ± 48.0 |
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.
| minutes | Chloroprocaine | Bupivacaine |
|---|---|---|
| Duration of Sensory Block | 127 ± 20.6 | 210 ± 56.1 |
The time difference between local anesthetic injection and patient's walking for the first time postoperatively.
| minutes | Chloroprocaine | Bupivacaine |
|---|---|---|
| Time to Ambulation | 110 ± 1.4 | 179 ± 2.6 |
The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.
| minutes | Chloroprocaine | Bupivacaine |
|---|---|---|
| Time to Micturation | 111 ± 1.3 | 233 ± 1.7 |
Collected over until the subjects were discharged form the post anesthesia care unit up to 6 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chloroprocaine | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Bupivacaine | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Chloroprocaine | Bupivacaine | Total |
|---|---|---|---|
| Mean | 33 ± 4.5 | 29 ± 3.8 | 31 ± 4.5 |
| Sex: Female, Male(Participants) | Chloroprocaine | Bupivacaine | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Chloroprocaine | Bupivacaine | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| BMI(Kg/m^2) | Chloroprocaine | Bupivacaine | Total |
|---|---|---|---|
| Mean | 30.4 ± 5.9 | 29.7 ± 5.9 | 30 ± 5.4 |
| ASA(Scores on a scale) | Chloroprocaine | Bupivacaine | Total |
|---|---|---|---|
| Mean | 2.3 ± 0.58 | 2 ± 0 | 2.1 ± 0.38 |
| Gestational age(weeks) | Chloroprocaine | Bupivacaine | Total |
|---|---|---|---|
| Mean | 16 ± 3.9 | 14.8 ± 3.7 | 15.4 ± 3.7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Aug 2018, 10 months.
Results were first posted in Aug 2020, 2 years after primary completion.
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Studies of the drug tested here: Chloroprocaine
Uterine Cervical Incompetence →