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NCT Number: NCT01892332

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

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.

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Key information

Age range

65 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

epidural block with lidocaine and fentanyl

Drug

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 4, 2013
Registry last updated
Jul 28, 2014

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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