Comparison of the Effects of Two Different Local Anesthetics Used in Spinal Anesthesia

Objective: This study aimed to compare the effects of two different local anesthetics with different baricity used in spinal anesthesia on thermoregulation.

Materials and Methods: The study was conducted on forty full-term pregnant women scheduled for elective cesarean sections under spinal anesthesia. At an operating room temperature of twenty-four degrees Celsius, peripheral body temperature was measured using temperature probes attached to the lower medial parts of the same side's lower and upper extremities, and central body temperature was measured with a tympanic thermometer. Isobaric levobupivacaine and hyperbaric bupivacaine were used in spinal anesthesia applications. After spinal anesthesia, tympanic temperature, arm and leg temperatures, mean arterial pressure, heart rate, and oxygen saturation were measured and recorded at baseline, the first, third, and fifth minutes, and every five minutes thereafter until the end of surgery.

Study Overview

• Status: Completed
• Conditions: Local Anaesthesia
• Intervention / Treatment: Drug: Chirocaine; Drug: Bupivacaine

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06290
    • Fatih University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study was conducted on 40 full-term pregnant women aged 18-40, classified as ASA I-II, who were scheduled for elective cesarean sections under spinal anesthesia. All patients included in the study were informed and gave their written and verbal consent.

Description

Inclusion Criteria:

• Term pregnant with elective cesarean section planned under spinal anesthesia
• ASA I-II
• 18-40 years old

Exclusion Criteria:

• patients in whom spinal anesthesia is contraindicated,
• patients with neuromuscular disease,
• alcohol and substance abusers,
• patients with a body mass index (BMI) <18.5 kg/m² or >35 kg/m²,
• those taking medications that may affect thermoregulation such as vasodilators,
• patients with thyroid disease,
• patients with fever and infection,
• patients with known allergies to study drugs.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Isobaric levobupivacaine	Drug: Chirocaine; Our study was conducted on forty full-term pregnant women scheduled for elective cesarean sections under spinal anesthesia. At an operating room temperature of twenty-four degrees Celsius, peripheral body temperature was measured using temperature probes attached to the lower medial parts of the same side's lower and upper extremities, and central body temperature was measured with a tympanic thermometer. Isobaric levobupivacaine was used in spinal anesthesia applications. After spinal anesthesia, tympanic temperature, arm and leg temperatures, mean arterial pressure, heart rate, and oxygen saturation were measured and recorded at baseline, the first, third, and fifth minutes, and every five minutes thereafter until the end of surgery.; Other Names: levobupivacaine
Hyperbaric bupivacaine	Drug: Bupivacaine; Our study was conducted on forty full-term pregnant women scheduled for elective cesarean sections under spinal anesthesia. At an operating room temperature of twenty-four degrees Celsius, peripheral body temperature was measured using temperature probes attached to the lower medial parts of the same side's lower and upper extremities, and central body temperature was measured with a tympanic thermometer. Hyperbaric bupivacaine was used in spinal anesthesia applications. After spinal anesthesia, tympanic temperature, arm and leg temperatures, mean arterial pressure, heart rate, and oxygen saturation were measured and recorded at baseline, the first, third, and fifth minutes, and every five minutes thereafter until the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature	Isobaric levobupivacaine or hyperbaric bupivacaine were used in spinal anesthesia applications. After spinal anesthesia, tympanic temperature, arm and leg temperatures were measured and recorded at the beginning, first, third and fifth minutes and then every five minutes until the end of the surgery.	During operation

Collaborators and Investigators

• Sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
• Collaborators: Fatih University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): April 30, 2015
• Study Completion (Actual): July 30, 2015

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Spinal anesthesia; Thermoregulation; Local anesthetics; Baricity
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Levobupivacaine; Bupivacaine
• Other Study ID Numbers: 26247029-514-04-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No