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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chloroprocaine (CP) | Experimental | Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroprocaine | Drug | Administered as a single injection or continuously through an indwelling catheter - 50 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%) | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Ambulate | Time from spinal anesthesia placement to ability to ambulate. | 5 hours |
| Time to Void | Time from spinal anesthesia injection to ability to void spontaneously. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Smiley, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24601887 | Background | 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. | |
| 21288208 |
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A research report will be written and submitted to a peer-reviewed journal
Submission will be made by December, 2020. Publication availability is to be determined by the peer review process. Once published, the data should be available indefinitely.
To be determined.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Women with an indication for cervical cerclage with spinal anesthesia
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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%) | 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. | Posted | Median | Inter-Quartile Range | minutes | 3 hours |
|
Up to postoperative day 1
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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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).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Allison Lee | Columbia University | 212-305-6494 | al3196@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 13, 2019 | May 7, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2019 | May 7, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| C004616 | chloroprocaine |
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| D012965 | Sodium Chloride |
| D005457 | Fluoridation |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine | Drug | A dextrose Solution is usually given as an injection - 9 mg (1.4 ml) |
|
|
| Fentanyl | Drug | 15 mcg Fentanyl will be included int he spinal anesthetic in both groups |
|
|
| Saline | Drug | Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml |
|
|
| 5 hours |
| 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. |
| 34153006 | Derived | 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. |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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 |
| OG001 | 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 |
|
|
| Secondary | Time to Ambulate | Time from spinal anesthesia placement to ability to ambulate. | 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. | Posted | Median | Inter-Quartile Range | minutes | 5 hours |
|
|
|
| Secondary | Time to Void | Time from spinal anesthesia injection to ability to void spontaneously. | 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. | Posted | Median | Inter-Quartile Range | minutes | 5 hours |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
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| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
| D011636 | Public Health Dentistry |
| D004778 | Environment and Public Health |