Adverse Reaction to Spinal AnestheticPhase 4NCT02862912

Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

A Phase 4 study testing Chloroprocaine, Bupivacaine and Fentanyl in people with Adverse Reaction to Spinal Anesthetic and Maternal Care for Cervical Incompetence, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Adverse Reaction to Spinal Anesthetic, Maternal Care for Cervical Incompetence
What is being tested?: Chloroprocaine, Bupivacaine and Fentanyl
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: 8 Nov 2016to 31 Jan 2020
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 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

New York Presbyterian Hospital
New York, New York, 10032

Other trials in United States

About this study

Official title: Chloroprocaine Versus Bupivacaine Spinal Anesthesia for Cervical Cerclage

Read the 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.

Conditions: Adverse Reaction to Spinal Anesthetic, Maternal Care for Cervical Incompetence
Being tested: Chloroprocaine, Bupivacaine, Fentanyl, Saline
Keywords: Chloroprocaine, cervical cerclage, spinal anesthesia, Bupivacaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ChloroprocaineDrug
Also called Nesacaine
Administered as a single injection or continuously through an indwelling catheter - 50 mg
BupivacaineDrug
Also called Bupivacaine hydrochloride
A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)
FentanylDrug
Also called Sublimaze
15 mcg Fentanyl will be included int he spinal anesthetic in both groups
SalineDrug
Also called Salt water
Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml

Study groups in NCT02862912
Study group	Role	What they receive
Chloroprocaine (CP)	Experimental	Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml) Receives: Drug: Chloroprocaine; Drug: Fentanyl
Bupivacaine (BUP)	Active comparator	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 Receives: Drug: Bupivacaine; Drug: Fentanyl; Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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%)
Measured: 3 hours

Secondary outcomes (2)

Time to Ambulate
Time from spinal anesthesia placement to ability to ambulate.
Measured: 5 hours
Time to Void
Time from spinal anesthesia injection to ability to void spontaneously.
Measured: 5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 201631 Jan 2020

First posted11 Aug 2016 (estimated)
Study start8 Nov 2016
Primary completion31 Jan 2020
Study completion31 Jan 2020

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 (3)Papers the sponsor has linked to this study.
Other trials for Adverse Reaction to Spinal AnestheticStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02862912
Sponsor's protocol ID: AAAQ0916
Status last verified: Dec 2020
First submitted: 1 Aug 2016
Last updated: 24 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: A research report will be written and submitted to a peer-reviewed journal

Publications

Camponovo C, Wulf H, Ghisi D, Fanelli A, Riva T, Cristina D, Vassiliou T, Leschka K, Fanelli G. Intrathecal 1% 2-chloroprocaine vs. 0.5% bupivacaine in ambulatory surgery: a prospective, observer-blinded, randomised, controlled trial. Acta Anaesthesiol Scand. 2014 May;58(5):560-6. doi: 10.1111/aas.12291. Epub 2014 Mar 6.
PubMed 24601887
Hejtmanek MR, Pollock JE. Chloroprocaine for spinal anesthesia: a retrospective analysis. Acta Anaesthesiol Scand. 2011 Mar;55(3):267-72. doi: 10.1111/j.1399-6576.2010.02371.x.
PubMed 21288208
Lee A, Shatil B, Landau R, Menon P, Smiley R. Intrathecal 2-Chloroprocaine 3% Versus Hyperbaric Bupivacaine 0.75% for Cervical Cerclage: A Double-Blind Randomized Controlled Trial. Anesth Analg. 2022 Mar 1;134(3):624-632. doi: 10.1213/ANE.0000000000005653.
PubMed 34153006

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Chloroprocaine Versus Bupivacaine Spinal Anesthesia for Cervical Cerclage
ClinicalTrials.gov ID: NCT02862912
Acronym / sponsor ID: AAAQ0916
Conditions: Adverse Reaction to Spinal Anesthetic, Maternal Care for Cervical Incompetence
Keywords: Chloroprocaine, cervical cerclage, spinal anesthesia, Bupivacaine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Study start: 8 Nov 2016 (actual)
Primary completion: 31 Jan 2020 (actual)
Study completion: 31 Jan 2020 (actual)
First posted: 11 Aug 2016 (estimated)
Results: Posted 26 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Chloroprocaine (CP)	Experimental	Drug: Chloroprocaine, Drug: FentanylPatients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)
Bupivacaine (BUP)	Active comparator	Drug: Bupivacaine, Drug: Fentanyl, Drug: SalinePatients 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

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

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)

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: NesacaineAdministered as a single injection or continuously through an indwelling catheter - 50 mg	Drug	Chloroprocaine (CP)
BupivacaineAlso: Bupivacaine hydrochlorideA dextrose Solution is usually given as an injection - 9 mg (1.4 ml)	Drug	Bupivacaine (BUP)
FentanylAlso: Sublimaze15 mcg Fentanyl will be included int he spinal anesthetic in both groups	Drug	Bupivacaine (BUP), Chloroprocaine (CP)
SalineAlso: Salt waterPreservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml	Drug	Bupivacaine (BUP)

Primary outcome

Time to Resolution of Motor Block
Time frame: 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%)

2 secondary outcomes

Time to Ambulate
Time frame: 5 hours
Time to Void
Time frame: 5 hours

Results and safety

Results posted to the registry on 26 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chloroprocaine (CP)	23	22
Bupivacaine (BUP)	20	20

Primary outcome: Time to Resolution of Motor Block

Time frame: 3 hours. Median (Inter-Quartile Range). Unit: minutes

Measure	Chloroprocaine (CP) n = 22	Bupivacaine (BUP) n = 17
Value	109 (88 to 148)	112 (97 to 143)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to postoperative day 1. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chloroprocaine (CP)	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Bupivacaine (BUP)	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): Despite low dropout risk, we proposed to enroll an additional 4 subjects/group above calculated sample size. The significantly shorter discharge times among some subjects became increasingly apparent. It became untenable to claim clinical equipoise. After the originally calculated sample size was achieved, we decided to stop enrolling new cases, accounting for uneven group numbers. A Shapiro-Wilk test indicated block resolution and discharge time data was non-normal (medians \[IQR\] reported).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24601887Camponovo C, Wulf H, Ghisi D, Fanelli A, Riva T, Cristina D, Vassiliou T, Leschka K, Fanelli G. Intrathecal 1% 2-chloroprocaine vs. 0.5% bupivacaine in ambulatory surgery: a prospective, observer-blinded, randomised, controlled trial. Acta Anaesthesiol Scand. 2014 May;58(5):560-6. doi: 10.1111/aas.12291. Epub 2014 Mar 6.
Background: PubMed 21288208Hejtmanek MR, Pollock JE. Chloroprocaine for spinal anesthesia: a retrospective analysis. Acta Anaesthesiol Scand. 2011 Mar;55(3):267-72. doi: 10.1111/j.1399-6576.2010.02371.x.
Derived from this study: PubMed 34153006Lee A, Shatil B, Landau R, Menon P, Smiley R. Intrathecal 2-Chloroprocaine 3% Versus Hyperbaric Bupivacaine 0.75% for Cervical Cerclage: A Double-Blind Randomized Controlled Trial. Anesth Analg. 2022 Mar 1;134(3):624-632. doi: 10.1213/ANE.0000000000005653.
Individual participant dataSharing planned: Yes. A research report will be written and submitted to a peer-reviewed journal

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.

Richard Smiley, MD principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 24 Dec 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 26 May 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?

Time to Resolution of Motor Block (time frame: 3 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 NCT02862912, which also lists 3 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 24 Dec 2020.