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.

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Key information

Conditions

Local Anaesthesia

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Fatih University

Ankara, 06290, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Primary outcomes

Temperature

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara Ataturk Sanatorium Training and Research Hospital

Other Gov

Collaborators

Fatih University

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jan 8, 2025
Registry last updated: Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed