The Effect of Injection Rate of Local Anesthetic in Caesarean Section
Does the Injection Rate of Local Anesthetic Affect the Onset of Sensory Block and Incidence of Hypotension in Caesarean Section
2 other identifiers
interventional
67
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedFirst Submitted
Initial submission to the registry
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
October 25, 2021
CompletedFebruary 4, 2022
January 1, 2022
12 months
October 12, 2021
January 31, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Hypotension
The time to onset of hypotension was significantly shorter in Group F
2 minutes interval
Study Arms (2)
Group S:33
ACTIVE COMPARATOR120-second local anesthesic (% 0,5 Bupivacaine) injection time
Group F:34
ACTIVE COMPARATOR15-second local anesthesic(% 0,5 Bupivacaine) injection time
Interventions
Administering intrathecal local anesthetics for all patients according to height and weight.
Eligibility Criteria
You may qualify if:
- Anesthesiologists risk score (ASA) I-II risk status
- Singleton pregnancy aged
- Between 18-40 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karadeniz Technical University
Trabzon, 61080, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ersagun tugcugil
KARADENİZ TEKNİK ÜNİVERSİTESİ DEPARTMENT OF ANESTHESİOLOGİA AND REANİMATİON
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass. Prof.
Study Record Dates
First Submitted
October 12, 2021
First Posted
October 25, 2021
Study Start
February 11, 2020
Primary Completion
January 25, 2021
Study Completion
July 30, 2021
Last Updated
February 4, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share