Epidural Anesthesia for Transurethral Resection of The Prostate

NCT06893809 | Completed Results

• 2 other identifiers: ANEAH2010Corresponding Author
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epidural Catheter; Epidural Analgesia; Geriatric Cardiology; Urologic Disorders; Hemodynamic (MAP) Stability; Pain Management

Keywords

Transurethral resection of the prostate; epidural anesthesia

Outcome Measures

Primary Outcomes (1)

• Time to Reach Sensory Block at T10

  Times to reach sensory block T10 (block levels)

  Within 20 minutes after anesthetic administration

Secondary Outcomes (4)

• Change in Systolic Blood Pressure (SBP)

  From 5 minutes after sedation to 20 minutes after epidural block

• Maximum Sensory Block Level at the 20th Minute Post-Epidural Block

  20 minutes after epidural administration

• Motor Block Intensity Based on Bromage Score at 20 Minutes

  20 minutes after epidural block administration

• Degree of Sensory Block Regression at 60 Minutes Post-Epidural Block

  60 minutes after epidural block administration

Study Arms (3)

Group N

ACTIVE COMPARATOR

Group N (Needle)

Procedure: Epidural injection via catheter; Procedure: Combined epidural injection (needle and catheter)

Group C

ACTIVE COMPARATOR

Group C (Catheter)

Procedure: Epidural injection via Tuohy needle; Procedure: Combined epidural injection (needle and catheter)

Group N/C

ACTIVE COMPARATOR

Group N/C (Needle/Catheter)

Procedure: Epidural injection via Tuohy needle; Procedure: Epidural injection via catheter

Interventions

Epidural injection via Tuohy needle PROCEDURE

Local anesthetic was administered entirely through the Tuohy needle.

Also known as: Epidural anesthesia - needle route

Group C; Group N/C

Epidural injection via catheter PROCEDURE

Local anesthetic was administered entirely through the epidural catheter.

Also known as: Epidural anesthesia - catheter route

Group N; Group N/C

Combined epidural injection (needle and catheter) PROCEDURE

Half of the total local anesthetic dose was administered through the needle and half through the catheter.

Also known as: Epidural anesthesia - combined route

Group C; Group N

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: Male patients undergoing transurethral prostatic resection
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male undergoing transurethral prostatic resection,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead
• Ankara City Hospital Bilkent: collaborator

Study Sites (1)

Ankara Numune Education and Research Hospital

Ankara, Altındağ, 06080, Turkey (Türkiye)

Location

Related Publications (14)

• Barbosa FT, Castro AA. Neuraxial anesthesia versus general anesthesia for urological surgery: systematic review. Sao Paulo Med J. 2013;131(3):179-86. doi: 10.1590/1516-3180.2013.1313535.

  PMID: 23903267 BACKGROUND

• Kim JH, Lee JS, Kim DY. Direction of catheter insertion and the incidence of paresthesia during continuous epidural anesthesia in the elderly patients. Korean J Anesthesiol. 2013 May;64(5):443-7. doi: 10.4097/kjae.2013.64.5.443. Epub 2013 May 24.

  PMID: 23741568 BACKGROUND

• Horlocker TT, Abel MD, Messick JM Jr, Schroeder DR. Small risk of serious neurologic complications related to lumbar epidural catheter placement in anesthetized patients. Anesth Analg. 2003 Jun;96(6):1547-1552. doi: 10.1213/01.ANE.0000057600.31380.75.

  PMID: 12760972 BACKGROUND

• Yun MJ, Kim YC, Lim YJ, Choi GH, Ha M, Lee JY, Ham BM. The differential flow of epidural local anaesthetic via needle or catheter: a prospective randomized double-blind study. Anaesth Intensive Care. 2004 Jun;32(3):377-82. doi: 10.1177/0310057X0403200313.

  PMID: 15264734 BACKGROUND

• Omote K, Namiki A, Iwasaki H. Epidural administration and analgesic spread: comparison of injection with catheters and needles. J Anesth. 1992 Jul;6(3):289-93. doi: 10.1007/s0054020060289.

  PMID: 15278539 BACKGROUND

• Crochetiere CT, Trepanier CA, Cote JJ. Epidural anaesthesia for caesarean section: comparison of two injection techniques. Can J Anaesth. 1989 Mar;36(2):133-6. doi: 10.1007/BF03011434.

  PMID: 2650896 BACKGROUND

• Visser WA, Lee RA, Gielen MJ. Factors affecting the distribution of neural blockade by local anesthetics in epidural anesthesia and a comparison of lumbar versus thoracic epidural anesthesia. Anesth Analg. 2008 Aug;107(2):708-21. doi: 10.1213/ane.0b013e31817e7065.

  PMID: 18633056 BACKGROUND

• Cesur M, Alici HA, Erdem AF, Silbir F, Yuksek MS. Administration of local anesthetic through the epidural needle before catheter insertion improves the quality of anesthesia and reduces catheter-related complications. Anesth Analg. 2005 Nov;101(5):1501-1505. doi: 10.1213/01.ANE.0000181005.50958.1E.

  PMID: 16244020 BACKGROUND

• Ulker B, Erbay RH, Serin S, Sungurtekin H. Comparison of spinal, low-dose spinal and epidural anesthesia with ropivacaine plus fentanyl for transurethral surgical procedures. Kaohsiung J Med Sci. 2010 Apr;26(4):167-74. doi: 10.1016/S1607-551X(10)70025-5.

  PMID: 20434097 BACKGROUND

• Sorenson RM, Pace NL. Anesthetic techniques during surgical repair of femoral neck fractures. A meta-analysis. Anesthesiology. 1992 Dec;77(6):1095-104. doi: 10.1097/00000542-199212000-00009.

  PMID: 1466461 BACKGROUND

• Bernstein S, Malhotra V. Regional anesthesia for genitourinary surgery. In Malhotra V (ed): Anesthesia for Renal And Genitourinary

  BACKGROUND

• Blake DW. The general versus regional anaesthesia debate: time to re-examine the goals. Aust N Z J Surg. 1995 Jan;65(1):51-6. doi: 10.1111/j.1445-2197.1995.tb01748.x.

  PMID: 7818424 BACKGROUND

• Morgan GE, Mikhail MS, Murray MJ, Larson CP. Regional Anesthesia &Pain Management, Clinical Anesthesiology. 3rd edition. Los Angeles:

  BACKGROUND

• Tsui BC, Wagner A, Finucane B. Regional anaesthesia in the elderly: a clinical guide. Drugs Aging. 2004;21(14):895-910. doi: 10.2165/00002512-200421140-00001.

  PMID: 15554749 BACKGROUND

Related Links

• jscimedcentral

MeSH Terms

Conditions

Urologic Diseases; Agnosia

Interventions

Needles; Catheters

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Limitations and Caveats

The study's findings are subject to at least two limitations. Firstly, the participants were members of an advanced age group, which is known to be associated with an increased prevalence of comorbidities. Secondly, the duration of surgery was longer than expected, which may be indicative of a more complex and time-consuming surgical procedure.

Results Point of Contact

• Title: Dr. Emine Ozcan
• Organization: Başakşehir Çam and Sakura City Hospital

dr.emine3419@gmail.com

05301592856

Study Officials

• NERMİN GÖĞÜŞ, Prof.Dr.

  Ankara City Hospital Bilkent

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 25, 2025
• Study Start: January 2, 2010
• Primary Completion: November 30, 2010
• Study Completion: December 30, 2010
• Last Updated: July 25, 2025
• Results First Posted: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Timeless
• Access Criteria: All researchers can access all information.

Locations

TU (1)