The Effect of Injection Rate of Local Anesthetic in Caesarean Section

Anesthesia, Spinal Clinical Trial

Official title:

Does the Injection Rate of Local Anesthetic Affect the Onset of Sensory Block and Incidence of Hypotension in Caesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05091294
• Other study ID #: 2020-52
• Secondary ID: Ahmet Besir
• Status: Completed
• Phase: N/A
• Start date: February 11, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: January 2022
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized double-blind study aimed to compare the effects of two different subaracnoid lokal anesthetic injection rate in cesarean section. Totally 67 patients were included. The groups were compared in terms of maximum sensory and motor block level, time to reach T6 level, hemodynamic changes and nausea- vomiting saved.

Description:

A total of 67 patients 18-40 years undergoing cesarean, who were graded as American Society of Anesthesiologists physical status were randomly allocated into two groups, 120-sn injection time (n=34, Group F), 15-sn injection time (n=33, Group S). When the level of the sensory block achieve the T6 level the surgery was let to begin. The groups were compared in terms of hemodynamic values, use of efedrin, the time to achieve sensory block to the T6 level, maximum sensory block level and motor block level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 30, 2021
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Anesthesiologists risk score (ASA) I-II risk status
• Singleton pregnancy aged
• Between 18-40 years

Exclusion Criteria:

• Pregnant women with contraindications for spinal anesthesia;
• Placental anomaly;
• Hypertension
• Cardiac disease
• Vascular disease
• Hepatic disease
• Renal disease
• Hemodynamic instability
• Spinal deformity;
• Severe mental retardation
• Weight < 50 kg or >110 kg; height < 140 cm or > 180 cm
• Metabolic and Acid-base balance disorders
• Emergency patients

Related Conditions & MeSH terms

• Anesthesia, Obstetrical
• Anesthesia, Spinal

Intervention

Other:
• Local anesthetic injection rate in spinal anesthesia
Administering intrathecal local anesthetics for all patients according to height and weight.

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensory block	The time to reach the sufficient sensory block and maximum level of sensory block was significantly shorter in Group S	2 minutes interval
Primary	Hypotension	The time to onset of hypotension was significantly shorter in Group F	2 minutes interval