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

NCT06763510 | Completed

• 1 other identifier: 26247029-514-04-01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Local Anaesthesia

Keywords

Spinal anesthesia; Local anesthetics; Thermoregulation; Baricity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Isobaric levobupivacaine

Drug: Chirocaine

Hyperbaric bupivacaine

Drug: Bupivacaine

Interventions

Chirocaine DRUG

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.

Also known as: levobupivacaine

Isobaric levobupivacaine

Bupivacaine DRUG

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.

Hyperbaric bupivacaine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Ataturk Sanatorium Training and Research Hospital: lead
• Fatih University: collaborator

Study Sites (1)

Fatih University

Ankara, 06290, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Levobupivacaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 8, 2025
• Study Start: February 1, 2015
• Primary Completion: April 30, 2015
• Study Completion: July 30, 2015
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)