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

Completed

• Conditions: Local Anaesthesia
• Interventions: Drug: Bupivacaine; Drug: Chirocaine

• Registration Number: NCT06763510
• Lead Sponsor: Ankara Ataturk Sanatorium Training and Research Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-01
• Primary Completion: 2015-04-30
• Study Completion: 2015-07-30
• Study First Submitted: 2024-12-31
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-07
• Study First Posted: 2025-01-08
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hyperbaric bupivacaine	Bupivacaine	-
Isobaric levobupivacaine	Chirocaine	-

Primary Outcome Measures

Name	Time	Method
Temperature	During operation	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.

Trial Locations

Locations (1)

Fatih University; 🇹🇷 Ankara, Turkey