Comparison of Clorotekal and Bupivacaine for Short Obstetric Surgery

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · May 26, 2019

Keywords

ClinConnect Summary

This will be a single-blind, randomized, controlled, single center clinical trial assessing the efficacy of spinal chloroprocaine on resolution of motor block and associated patient flow through the post-anesthesia care unit . Fifty patients will be equally randomized to receive either spinal chloroprocaine or hyperbaric bupivacaine.

Masking:

1. Subject
2. Obstetric provider
3. Investigator
4. Outcomes assessor

The anesthesia provider will be unblinded.

Subjects will be allocated to either intrathecal injection of 50 mg of 1% chloroprocaine or 10.5 mg (1.4 mL) of 0.75% hyperbaric bupiva...

Gender

FEMALE

Eligibility 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