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

BPH( Benign Prostate Hyperplasia) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892332
• Other study ID #: 4-2013-0257
• Status: Completed
• Phase: N/A
• First received: June 30, 2013
• Last updated: July 24, 2014
• Start date: June 2013
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• BPH( Benign Prostate Hyperplasia)
• Hyperplasia
• Prostatic Hyperplasia
• TURP(Transurethral Resection of Prostate)

Intervention

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%.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining the effective concentration of lidocaine with fentanyl in lumbar epidural anesthesia for transurethral resection of prostate(TURP) in elderly patients	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.	A blinded Assistant assess sensory and motor blockade in a 2-min intervals up to 60 minutes.	No