NCT06893809

Epidural Anesthesia for Transurethral Resection of The Prostate

Completed NA Results posted Last updated 25 July 2025

What this trial tests

NA trial testing Epidural injection via Tuohy needle in Epidural Catheter in 60 participants. Completed in 30 December 2010.

Timeline

2 January 2010

Primary endpoint
30 November 2010

30 December 2010

Quick facts

Lead sponsor	Başakşehir Çam & Sakura City Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	2 January 2010
Primary completion	30 November 2010
Estimated completion	30 December 2010
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Epidural injection via Tuohy needle
• Epidural injection via catheter
• Combined epidural injection (needle and catheter)

Conditions studied

• Epidural Catheter — all drugs for Epidural Catheter →
• Epidural Analgesia — all drugs for Epidural Analgesia →
• Geriatric Cardiology — all drugs for Geriatric Cardiology →
• Urologic Disorders — all drugs for Urologic Disorders →

Sponsor

Başakşehir Çam & Sakura City Hospital

Who can join

Adults 40 to 75, male only, with Epidural Catheter or Epidural Analgesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Reach Sensory Block at T10 Primary · Within 20 minutes after anesthetic administration

Times to reach sensory block T10 (block levels)

Group	Value	95% CI
Group N	15.25	± 1.97
Group C	10.50	± 1.54
Group N/C	11.25	± 2.22

Change in Systolic Blood Pressure (SBP) Secondary · From 5 minutes after sedation to 20 minutes after epidural block

Change in Systolic Blood Pressure from Sedation to 20 Minutes Post-Epidural Block

Sedation SBP (mean ± SD)

Group	Value	95% CI
Group N	126.70	± 13.80
Group C	123.80	± 8.61
Group N/C	126.70	± 13.80

Post-Block 20th Min SBP (mean ± SD)

Group	Value	95% CI
Group N	116.80	± 16.04
Group C	116.40	± 11.99
Group N/C	121.10	± 13.50

Maximum Sensory Block Level at the 20th Minute Post-Epidural Block Secondary · 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.

Group	Value	95% CI
Group N	3.20	± 0.52
Group C	4.10	± 0.55
Group N/C	4.25	± 0.54

Motor Block Intensity Based on Bromage Score at 20 Minutes Secondary · 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.

Group	Value	95% CI
Group N	0.30	± 0.66
Group C	0.60	± 1.00
Group N/C	0.20	± 0.62

Degree of Sensory Block Regression at 60 Minutes Post-Epidural Block Secondary · 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.

Group	Value	95% CI
Group N	2.3	± 0.47
Group C	2.8	± 0.86
Group N/C	2.5	± 0.61

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.