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Completed

NCT Number: NCT05091294

The Effect of Injection Rate of Local Anesthetic 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.

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Key information

Conditions

Anesthesia, Spinal Anesthesia, Obstetrical

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Local anesthetic injection rate in spinal anesthesia

Other

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

Primary outcomes

  1. 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. Hypotension

    Time frame: 2 minutes interval

    The time to onset of hypotension was significantly shorter in Group F

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 25, 2021
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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