Epidural Anesthesia for Transurethral Resection of The Prostate

July 24, 2025 updated by: Emine OZCAN, Başakşehir Çam & Sakura City Hospital

Effects of Different Routes of Local Anesthetic Administration in Epidural Anesthesia for Transurethral Resection of The Prostate

The aim of this study is to assess the effects of different routes of local anesthetic administration in epidural anesthesia applied to patients undergoing transurethral resection of the prostate (TUR-P). ASA I-III 60 patients were enrolled in the study. Patients were randomized into the following three groups: in Group N (needle), total dose of local anesthetic was administered through the Tuohy needle (n=20), in Group C (catheter), local anesthetic was administered through the epidural catheter (n=20) and in Group N/C (needle/catheter), local anestetic was administered half volume through the needle and half through the catheter (n=20). Hemodynamics, times to reach sensory block T10 (block levels), side effects, patient and surgeon satisfaction were evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In urological procedures, the preferred anaesthetic modalities may be topical, regional or general. The decision is made by the anaesthesiologists based on patient age, sex, general condition and the surgical procedure to be performed. Transurethral procedures are frequently applied to geriatric patients, who are more likely to have comorbidities. In such cases, epidural anaesthesia may be preferred for geriatric patients.

In this study, we utilised various routes for the administration of local anaesthetics to induce epidural anaesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia. The study encompassed the evaluation of haemodynamic stability, the time to reach sensory block T10, the occurrence of side effects, and the levels of patient and surgeon satisfaction.

Following the approval of the hospital ethics committee, 60 male patients aged 40-75, ASA class I-III, scheduled for elective TUR-P surgery were enrolled in the study.According to the method of local anaesthetic administration, patients were randomly divided into three groups:

Group N (needle); total local anaesthetic administered through the Tuohy needle,Group C (catheter); local anaesthetic administered through the epidural catheter,Group NC (needle/catheter); 50% of local anaesthetic administered through the needle and 50% through the catheter.Patients underwent standard monitorisation in the operating theatre. Each patient received 0.03 mg/kg of midazolam intravenously following catheterisation with a 20-gauge intravenous cannula.Prior to the commencement of epidural block, patients were preloaded with 10 ml/kg of 0.9% isotonic saline infused over a 30-minute period. The hemodynamic parameters were then recorded before and after the premedication, following the epidural block, and every 5 minutes until the patient's sensory block level regressed to L1 dermatome.The epidural anaesthesia was then attempted with an 18-gauge Tuohy needle at the L3-4 interspinal level using the loss of resistance technique following infiltration with 2% lidocaine. Patients in Group N received a mixture of 8ml 2% prilocaine, 7ml 0.5% levobupivacaine and 50μg fentanyl through the epidural space using a Tuohy needle. Patients in Group C received the same drug combination through the epidural catheter. Patients in Group NC received half of the same drug combination through the needle and half through the epidural catheter. Patients were positioned in the right lateral decubitus position with thighs flexed up and neck flexed forward (fetal position), and then placed supine following drug administration.In all groups, time "0" was considered as the time that drug administration was started.

The sensory and motor block levels, heart rates and mean arterial blood pressure values, times to reach sensory block level T10, and side effects were recorded for all patients. Patient and surgeon satisfaction levels were evaluated using a 3-point satisfaction scale by an observer unaware of the study's objectives.Surgeon satisfaction was evaluated during the operation, and patient satisfaction was assessed in the recovery room before patients were transferred to their service bed.

Post-operatively, patients were admitted to the recovery room, the epidural catheter was removed following regression of sensory block to T10 dermatome, and patients were transferred to the service.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altındağ
      • Ankara, Altındağ, Turkey, 06080
        • Ankara Numune Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male undergoing transurethral prostatic resection,
  • 40 to 75 years old,
  • ASA-I-III
  • Not using anticoagulants or antiaggregants,
  • No peripheral neuropathy or muscle disease,
  • Can be orientated and co-operated,
  • No vertebral deformity,
  • Body Mass Index <30,
  • Patients consenting to epidural anaesthesia.

Exclusion Criteria:

  • TUR-P operation will not be male,
  • Female patients,
  • ASA-IV,
  • Not in the appropriate age range (40-75),
  • Taking anticoagulants or antiaggregants, Previous lumbar surgery or skeletal deformity in the lumbar region,
  • Peripheral neuropathy, neuromuscular or neuropsychiatric disease,
  • Alcohol or drug addiction,
  • Obese with a body mass index >30,
  • History of frequent analgesic use,
  • Patients shorter than 155 cm and taller than 180 cm,
  • Who refused epidural anaesthesia,
  • Patients without orientation and co-operation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group N
Group N (Needle)
Procedure: Epidural injection via catheter
Local anesthetic was administered entirely through the epidural catheter.
Other Names:
  • Epidural anesthesia - catheter route
Procedure: Combined epidural injection (needle and catheter)
Half of the total local anesthetic dose was administered through the needle and half through the catheter.
Other Names:
  • Epidural anesthesia - combined route
Active Comparator: Group C
Group C (Catheter)
Procedure: Combined epidural injection (needle and catheter)
Half of the total local anesthetic dose was administered through the needle and half through the catheter.
Other Names:
  • Epidural anesthesia - combined route
Procedure: Epidural injection via Tuohy needle
Local anesthetic was administered entirely through the Tuohy needle.
Other Names:
  • Epidural anesthesia - needle route
Active Comparator: Group N/C
Group N/C (Needle/Catheter)
Procedure: Epidural injection via catheter
Local anesthetic was administered entirely through the epidural catheter.
Other Names:
  • Epidural anesthesia - catheter route
Procedure: Epidural injection via Tuohy needle
Local anesthetic was administered entirely through the Tuohy needle.
Other Names:
  • Epidural anesthesia - needle route

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Reach Sensory Block at T10
Time Frame: Within 20 minutes after anesthetic administration
Times to reach sensory block T10 (block levels)
Within 20 minutes after anesthetic administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure (SBP)
Time Frame: From 5 minutes after sedation to 20 minutes after epidural block
Change in Systolic Blood Pressure from Sedation to 20 Minutes Post-Epidural Block
From 5 minutes after sedation to 20 minutes after epidural block
Maximum Sensory Block Level at the 20th Minute Post-Epidural Block
Time Frame: 20 minutes after epidural administration

Dermatomes were converted to numerical scores for statistical analysis:

L1 = 1, T12 = 2, T10 = 3, T8 = 4, T6 = 5. Maximum sensory block level was assessed by converting dermatomal levels to numerical scores: L1 = 1, T12 = 2, T10 = 3, T8 = 4, T6 = 5. Higher scores indicate higher (more cephalad) dermatomal levels, which are considered better outcomes in terms of anesthetic spread.
20 minutes after epidural administration
Motor Block Intensity Based on Bromage Score at 20 Minutes
Time Frame: 20 minutes after epidural block administration

Motor block was assessed using the modified Bromage scale:

0 = No motor block

  1. = Partial block (able to move knees and feet)
  2. = Moderate block (unable to flex knees, able to move feet)
  3. = Complete block (unable to move feet or legs). Scores range from 0 (best outcome, least block) to 3 (worst outcome, complete motor block). Lower scores indicate better functional recovery.
20 minutes after epidural block administration
Degree of Sensory Block Regression at 60 Minutes Post-Epidural Block
Time Frame: 60 minutes after epidural block administration
Sensory block regression at 60 minutes post-epidural block was assessed by converting dermatomal levels into numerical scores: L1 = 1, T12 = 2, T10 = 3. This scoring reflects the highest remaining level of sensory block at 60 minutes. Lower scores indicate greater regression of the block, meaning faster recovery. The minimum score is 1 and the maximum is 3.
60 minutes after epidural block administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Başakşehir Çam & Sakura City Hospital

Collaborators

Ankara City Hospital Bilkent

Investigators

  • Study Chair: NERMİN GÖĞÜŞ, Prof.Dr., Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2010

Primary Completion (Actual)

November 30, 2010

Study Completion (Actual)

December 30, 2010

Study Registration Dates

First Submitted

March 9, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

July 25, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANEAH2010
  • Corresponding Author (Other Identifier: Başakşehir Cam and Sakura City Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All results

IPD Sharing Time Frame

Timeless

IPD Sharing Access Criteria

All researchers can access all information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. Clinical Study Report
    Information identifier: https://www.jscimedcentral.com
    Information comments: Int J Clin Anesthesiol 4(1): 1050 (2016)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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