The Effect of Injection Rate of Local Anesthetic in Caesarean Section

Not Applicable

Completed

• Conditions: Anesthesia, Obstetrical; Anesthesia, Spinal
• Interventions: Other: Local anesthetic injection rate in spinal anesthesia

• Registration Number: NCT05091294
• Lead Sponsor: Karadeniz Technical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-02-11
• Primary Completion: 2021-01-25
• Study Completion: 2021-07-30
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-10-25
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group F:34	Local anesthetic injection rate in spinal anesthesia	15-second local anesthesic(% 0,5 Bupivacaine) injection time
Group S:33	Local anesthetic injection rate in spinal anesthesia	120-second local anesthesic (% 0,5 Bupivacaine) injection time

Primary Outcome Measures

Name	Time	Method
sensory block	2 minutes interval	The time to reach the sufficient sensory block and maximum level of sensory block was significantly shorter in Group S
Hypotension	2 minutes interval	The time to onset of hypotension was significantly shorter in Group F

Trial Locations

Locations (1)

Karadeniz Technical University; 🇹🇷 Trabzon, Turkey