Comparison of Clorotekal and Bupivacaine for Short Obstetric Surgery

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: Female

Summary

The following obstetric procedures are commonly performed with spinal anesthesia on labor and delivery: bilateral tubal ligation, external cephalic version, cerclage insertion, cerclage removal, minimally invasive fetal surgery, and evacuation of retained products of conception. Bupivacaine is currently the standard spinal medication for these procedures because of its long history of safe use, its low incidence of transient neurologic symptoms, and its ability to provide a dependable, dense block with a high degree of maternal satisfaction. While bupivacaine has the aforementioned advantages, it unfortunately has a long duration of action, up to 240-380 minutes, which far exceeds the time necessary to complete most obstetric procedures. Clorotekal®, the first Food and Drug Administration approved chloroprocaine solution created for spinal injection, is a potential alternative. When compared with bupivacaine spinals, chloroprocaine spinals have been shown to facilitate clinically significant shorter times to resolution of motor and sensory block, first ambulation, micturition, and discharge readiness. The objective of this study is to determine if a strategy of spinal anesthesia with chloroprocaine will reduce the duration of motor block, compared with equivalent block with hyperbaric bupivacaine..

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: B. Braun Medical Inc.
• Treatments: Bupivacaine; Chloroprocaine; Procaine

Criteria

Inclusion Criteria:

1. Women 18 years old to 60 years old

2. American Society of Anesthesiologists physical status class 1-3

3. Undergoing one of the following obstetric procedures: bilateral tubal ligation, external cephalic version, cerclage insertion, cerclage removal, minimally invasive fetal surgery, or evacuation of retained products of conception.

Exclusion Criteria:

1. Refusal of consent

2. Multiple gestations

3. History of ester local anesthetic or para-aminobenzoic acid allergy

4. Height less than 5 feet or greater than 6 feet

5. Body mass index less than 18.5 kg/m2 or greater than 45 kg/m2

6. Any coagulopathy defined by platelets < 80k/microliter, International Normalized Ratio > 1.2, or Partial Thromboplastin Time > 36 seconds

7. Signs of hypovolemia that is not corrected by routine management including hypotension (systolic blood pressure < 90 mm Hg) at the time of evaluation

8. Liver disease including jaundice and ascites, with elevated liver function tests, Aspartate Aminotransferase > 2x institutional normal, Alanine Aminotransferase > 2x institutional normal

9. Renal disease including history of dialysis, with elevated renal function tests on admission labs, glomerular filtration rate < 60 ml/min/1.73 m2

10. Infection at the site of potential spinal insertion

11. Neurologic condition that contraindicates spinal anesthesia, tethered spinal cord or multiple sclerosis

12. Known atypical plasma cholinesterase activity

13. Other contraindications to receive a spinal anesthetic

14. Vulnerable populations including prisoners and decisionally impaired adults