Cervical IncompetencePhase 4NCT03305575
Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage
A Phase 4 study testing Chloroprocaine and Bupivacaine in people with Cervical Incompetence, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cervical Incompetence
- What is being tested?
- Chloroprocaine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2017to 24 Aug 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA classification II or III females
- Age: 18-45 years old
- BMI ≤ 50 kg/m2
- Singleton pregnancy
- Simple prophylactic cervical cerclage
- Planning neuraxial anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial of Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage
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.
Read the 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.
- Conditions
- Cervical Incompetence
- Being tested
- Chloroprocaine, Bupivacaine
- Keywords
- Cervical Cerclage, Bupivacaine, Chloroprocaine, spinal anesthesia
- Medical subject headings
- Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroprocaineDrug
Also called 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.
BupivacaineDrug
Also called Marcaine
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.
| Study group | Role | What they receive |
|---|---|---|
| Chloroprocaine | Experimental | 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) Receives: Drug: Chloroprocaine |
| Bupivacaine | Active comparator | 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). Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 hours
Secondary outcomes (3)
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.
Measured: 6 hours
Time to Ambulation
The time difference between local anesthetic injection and patient's walking for the first time postoperatively.
Measured: 6 hours
Time to Micturation
The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start13 Oct 2017
- Primary completion24 Aug 2018
- Study completion24 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical IncompetenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double blinded clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Drzymalski, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305575
- Sponsor's protocol ID
- 12619
- Status last verified
- Aug 2020
- First submitted
- 4 Oct 2017
- Last updated
- 25 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Concepcion M, Covino BG. Rational use of local anaesthetics. Drugs. 1984 Mar;27(3):256-70. doi: 10.2165/00003495-198427030-00005.
PubMed 6705717Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M, Massicotte L. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anaesth. 2011 Apr;58(4):384-91. doi: 10.1007/s12630-010-9450-x. Epub 2011 Jan 4.
PubMed 21203878Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with small-dose bupivacaine in volunteers. Anesth Analg. 2005 Feb;100(2):566-572. doi: 10.1213/01.ANE.0000143356.17013.A1.
PubMed 15673895Casati A, Fanelli G, Danelli G, Berti M, Ghisi D, Brivio M, Putzu M, Barbagallo A. Spinal anesthesia with lidocaine or preservative-free 2-chlorprocaine for outpatient knee arthroscopy: a prospective, randomized, double-blind comparison. Anesth Analg. 2007 Apr;104(4):959-64. doi: 10.1213/01.ane.0000258766.73612.d8.
PubMed 17377114Beilin Y, Zahn J, Abramovitz S, Bernstein HH, Hossain S, Bodian C. Subarachnoid small-dose bupivacaine versus lidocaine for cervical cerclage. Anesth Analg. 2003 Jul;97(1):56-61, table of contents. doi: 10.1213/01.ane.0000068940.36040.54.
PubMed 12818944
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage
- ClinicalTrials.gov ID
- NCT03305575
- Acronym / sponsor ID
- 12619
- Conditions
- Cervical Incompetence
- Keywords
- Cervical Cerclage, Bupivacaine, Chloroprocaine, spinal anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 24 Aug 2018 (actual)
- First posted
- 10 Oct 2017 (actual)
- Results
- Posted 25 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double blinded clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Chloroprocaine | Experimental | Drug: ChloroprocainePatients 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) |
| Bupivacaine | Active comparator | Drug: BupivacainePatients 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- ASA classification II or III females
- Age: 18-45 years old
- BMI ≤ 50 kg/m2
- Singleton pregnancy
- Simple prophylactic cervical cerclage
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChloroprocaineAlso: SensorcaineThe 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. | Drug | Chloroprocaine |
| BupivacaineAlso: MarcaineThe 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. | Drug | Bupivacaine |
Primary outcome
Duration of Motor Block
Time frame: 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
3 secondary outcomes
Duration of Sensory Block
Time frame: 6 hours
Time to Ambulation
Time frame: 6 hours
Time to Micturation
Time frame: 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6705717Concepcion M, Covino BG. Rational use of local anaesthetics. Drugs. 1984 Mar;27(3):256-70. doi: 10.2165/00003495-198427030-00005.
- Background: PubMed 21203878Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M, Massicotte L. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anaesth. 2011 Apr;58(4):384-91. doi: 10.1007/s12630-010-9450-x. Epub 2011 Jan 4.
- Background: PubMed 15673895Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with small-dose bupivacaine in volunteers. Anesth Analg. 2005 Feb;100(2):566-572. doi: 10.1213/01.ANE.0000143356.17013.A1.
- Background: PubMed 17377114Casati A, Fanelli G, Danelli G, Berti M, Ghisi D, Brivio M, Putzu M, Barbagallo A. Spinal anesthesia with lidocaine or preservative-free 2-chlorprocaine for outpatient knee arthroscopy: a prospective, randomized, double-blind comparison. Anesth Analg. 2007 Apr;104(4):959-64. doi: 10.1213/01.ane.0000258766.73612.d8.
- Background: PubMed 12818944Beilin Y, Zahn J, Abramovitz S, Bernstein HH, Hossain S, Bodian C. Subarachnoid small-dose bupivacaine versus lidocaine for cervical cerclage. Anesth Analg. 2003 Jul;97(1):56-61, table of contents. doi: 10.1213/01.ane.0000068940.36040.54.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Drzymalski, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chloroprocaine and Bupivacaine in people with Cervical Incompetence, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Motor Block (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03305575, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.