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

NCT ID: NCT01892332

Last Updated: 2014-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-03-31

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.

Conditions

BPH( Benign Prostate Hyperplasia); TURP(Transurethral Resection of Prostate)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

lidocaine with fentanyl 75ug

Group Type: OTHER

epidural block with lidocaine and fentanyl

Intervention Type: 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%.

Interventions

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%.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2013-0257

Identifier Type: -

Identifier Source: org_study_id