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The Effective Concentration of Lidocaine With Fentanyl in Lumbar Epidural Anesthesia for Transurethral Resection of Prostate(TURP) in Elderly Patients

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ClinicalTrials.gov Identifier: NCT01892332
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

Epidural lidocaine is widely used in anesthesia for urologic or lower abdominal surgery because of its rapid onset. But the epidural anesthesia using high concentration of lidocaine may cause excessive motor block and unwanted side effects such as nausea, vomiting and hypotension.

This is a study to determine the effective concentration of lidocaine with fentanyl in lumbar epidural anesthesia for transurethral resection of prostate in elderly patients.


Condition or disease Intervention/treatment Phase
BPH( Benign Prostate Hyperplasia) TURP(Transurethral Resection of Prostate) Drug: epidural block with lidocaine and fentanyl Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
lidocaine with fentanyl 75ug Drug: epidural block with lidocaine and fentanyl

The study method was a step-up/step-down sequence model where the dose for following patients was determined by the outcome of the preceding block. The starting concentration of lidocaine was 1.5 % mixed with fentanyl 75 ug. All patients receive 13mL of lidocaine with fentanyl 75ug. The concentration of lidocaine for subsequent patients is determined by the outcome in the previous patient according to up and down sequential allocation in 0.1% increments. In the case of block failure, the concentration of lidocaine was increased by 0.1%.

Conversely, block success resulted in a reduction in concentration by 0.1%.





Primary Outcome Measures :
  1. Determining the effective concentration of lidocaine with fentanyl in lumbar epidural anesthesia for transurethral resection of prostate(TURP) in elderly patients [ Time Frame: A blinded Assistant assess sensory and motor blockade in a 2-min intervals up to 60 minutes. ]
    The occurrence of sensory block up to at T 12 and motor function score of 3 or more on the modified Bromage scale were considered characteristics of a successful block. Moreover, the surgery should be concluded without any complementary analgesia to confirm the success of the anesthetic procedure.



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA 1 -3, patients scheduled for TURP( transurethral resection of prostate) were included

Exclusion Criteria:

  • Patients with any contraindication to epidural anesthesia were excluded.

    • cognitive impairment
    • coagulopathy
    • allergy to lidocaine
    • infection at the puncture site

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892332


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01892332     History of Changes
Other Study ID Numbers: 4-2013-0257
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Lidocaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General