The Effect of Injection Rate of Local Anesthetic in Caesarean Section

NCT ID: NCT05091294

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-11

Study Completion Date

2021-07-30

Brief Summary

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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

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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.

Conditions

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Anesthesia, Spinal Anesthesia, Obstetrical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group S:33

120-second local anesthesic (% 0,5 Bupivacaine) injection time

Group Type ACTIVE_COMPARATOR

Local anesthetic injection rate in spinal anesthesia

Intervention Type OTHER

Administering intrathecal local anesthetics for all patients according to height and weight.

Group F:34

15-second local anesthesic(% 0,5 Bupivacaine) injection time

Group Type ACTIVE_COMPARATOR

Local anesthetic injection rate in spinal anesthesia

Intervention Type OTHER

Administering intrathecal local anesthetics for all patients according to height and weight.

Interventions

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Local anesthetic injection rate in spinal anesthesia

Administering intrathecal local anesthetics for all patients according to height and weight.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karadeniz Technical University

OTHER

Sponsor Role lead

Responsible Party

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Ersagun Tugcugil

Ass. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ersagun tugcugil

Role: PRINCIPAL_INVESTIGATOR

KARADENİZ TEKNİK ÜNİVERSİTESİ DEPARTMENT OF ANESTHESİOLOGİA AND REANİMATİON

Locations

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Karadeniz Technical University

Trabzon, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Ahmet Beşir

Identifier Type: OTHER

Identifier Source: secondary_id

2020-52

Identifier Type: -

Identifier Source: org_study_id

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