The Effect of Injection Rate of Local Anesthetic in Caesarean Section

January 31, 2022 updated by: Ersagun Tugcugil, Karadeniz Technical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Trabzon, Turkey, 61080
        • Karadeniz Technical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group S:33
120-second local anesthesic (% 0,5 Bupivacaine) injection time
Other: Local anesthetic injection rate in spinal anesthesia
Administering intrathecal local anesthetics for all patients according to height and weight.
Active Comparator: Group F:34
15-second local anesthesic(% 0,5 Bupivacaine) injection time
Other: Local anesthetic injection rate in spinal anesthesia
Administering intrathecal local anesthetics for all patients according to height and weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensory block
Time Frame: 2 minutes interval
The time to reach the sufficient sensory block and maximum level of sensory block was significantly shorter in Group S
2 minutes interval
Hypotension
Time Frame: 2 minutes interval
The time to onset of hypotension was significantly shorter in Group F
2 minutes interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karadeniz Technical University

Investigators

  • Principal Investigator: Ersagun tugcugil, KARADENİZ TEKNİK ÜNİVERSİTESİ DEPARTMENT OF ANESTHESİOLOGİA AND REANİMATİON

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2020

Primary Completion (Actual)

January 25, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-52
  • Ahmet Beşir (Other Identifier: KaradenizTU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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