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Comparing the Effects of Levobupivacaine and Bupivacaine in Saddle Spinal Anesthesia

NCT04245774 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-01-29

No results posted yet for this study

Summary

İn this study; it was aimed to investigate the effects of equipotent doses of hyperbaric bupivacaine and hyperbaric levobupivacaine in outpatient anorectal surgery under saddle block. Sixty patients between the age of 18- 50 and in the risk group of ASA I-II included in the study. 7,5 mg of 0,5% hyperbaric bupivacaine or 7,5 mg of 0,5% hyperbaric levobupivacaine injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds. All patients kept in sitting position for 5 minutes with aid after intrathecal injection and than layed in supine position, finally they positioned in prone jack-knife. Hemodynamic parameters like NIBP, HR, SpO2, sensory and motor block characteristics, duration of analgesia, time of first voiding, mobilization time, patient and surgeon satisfaction, adverse effects and discharge time were recorded during and after surgery.

Conditions

  • Outpatients
  • General Surgery
  • Anorectal Disorder
  • Anesthesia
  • Drug Effect

Interventions

DRUG

Levobupivacaine (as Levobupivacaine Hydrochloride) 75 Mg/10 mL Solution for Injection Ampoule

7,5 mg (1.5 mL) of 0,5% hyperbaric levobupivacaine (1 mL 0.75% isobaric levobupivacaine (Chirocaine® 75 mg/10mL ampoule Abbott/Turkey, Nycomed Pharma/Norway) plus 0.24 mL 50% Dextrose (dextrose 120 mg) (Eczacıbaşı/Turkey) and 0.26 mL distilled water) injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds. All patients kept in sitting position for 5 minutes with aid after intrathecal injection and than layed in supine position, finally they positioned in prone jack-knife.

DRUG

Bupivacaine/Dextrose

7,5 mg (1.5 mL) of 0,5% hyperbaric bupivacaine (dextrose content 80 mg/mL) injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds. All patients kept in sitting position for 5 minutes with aid after intrathecal injection and than layed in supine position, finally they positioned in prone jack-knife.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Principal Investigators

  • Cengiz B DEMİREL, 1 · Gazi University (formerly)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-21
Primary Completion
2008-08-13
Completion
2008-12-17

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04245774 on ClinicalTrials.gov