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.
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
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
About this study
Official title: Chloroprocaine Versus Bupivacaine Spinal Anesthesia for Cervical Cerclage
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 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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard M. Smiley, Columbia University
- Investigators
- Richard Smiley, MD, Principal investigator, Columbia University
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 24601887Hejtmanek 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 21288208Lee 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