Trial Outcomes & Findings for Epidural Anesthesia for Transurethral Resection of The Prostate (NCT NCT06893809)

Results Overview

Times to reach sensory block T10 (block levels)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Within 20 minutes after anesthetic administration

Results posted on

2025-07-25

Participant Flow

The 2010 study at Ankara Numune Education and Training Hospital examined patients 40-75 undergoing transurethral prostatectomy. Excluded were those with certain health issues or specific procedures. Patients gave consent before being divided into three groups: NC for needle and catheter; C for catheter only; N for needle only.

Patients above ASA-III, with peripheral neuropathy, neuromuscular or neuropsychiatric disease, alcohol or drug addiction, obese (body mass index \>30), history of hypersensitivity to local anesthetic agents, scoliosis, low back pain or history of lumbar surgery, bleeding, coagulation disorder, infection, history of frequent analgesic use, shorter than 155 cm and taller than 180 cm were excluded from the study.

Participant milestones

Participant milestones
Measure	Group N Group N (Needle) The group in which the dose of local anaesthetic to be used for epidural anaesthesia is administered exclusively through the needle.	Group C Group C (Catheter) The group is characterised by the administration of the local anaesthetic dose for epidural anaesthesia, which is administered exclusively through the epidural catheter.	Group N/C Group N/C (Needle/Catheter) The total dose of local anaesthetic administered for epidural anaesthesia was divided into two equal parts; the first part was injected through the touhy needle, and the second part was administered after the epidural catheter had been inserted.
Overall Study STARTED	20	20	20
Overall Study COMPLETED	20	20	20
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Epidural Anesthesia for Transurethral Resection of The Prostate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group N (Needle) n=20 Participants In this study, we utilised various routes for the administration of local anaesthetic, with the objective of achieving epidural anaesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) for benign prostatic hyperplasia. The study encompassed the evaluation of haemodynamic stability, the times to reach T10 sensory block, the occurrence of side effects, and the levels of patient and surgeon satisfaction. Following approval by the hospital ethics committee, a total of 60 male patients aged between 40 and 75 years, with an American Society of Anesthesiologists (ASA) classification of I-III, scheduled for elective transurethral prostate surgery (TUR-P), were included in the study. Patients were randomly divided into three groups according to the type of local anaesthetic administration: Group N (needle); the total local anaesthetic dose was administered through a Tuohy needle.	Group C (Catheter) n=20 Participants In this study, we used various routes for local anaesthetic administration to achieve epidural anaesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) for benign prostatic hyperplasia. The study included evaluation of haemodynamic stability, times to reach T10 sensory block, occurrence of side effects and patient and surgeon satisfaction levels. Following approval by the hospital ethics committee, a total of 60 male patients aged 40-75 years, American Society of Anaesthesiologists (ASA) classification I-III, scheduled for elective transurethral prostate surgery (TUR-P) were included in the study. Patients were randomly divided into three groups according to the type of local anaesthetic administration: Group C (Catheter); the total dose of local anaesthetic was administered through an epidural catheter.	Group N/C (Needle/Catheter) n=20 Participants In this study, we used various routes for local anaesthetic administration to achieve epidural anaesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) for benign prostatic hyperplasia. Haemodynamic stability, times to reach T10 sensory block, occurrence of side effects and patient and surgeon satisfaction levels were evaluated. Following approval of the hospital ethics committee, a total of 60 male patients aged 40-75 years, American Society of Anaesthesiologists (ASA) classification I-III, scheduled for elective transurethral prostate surgery (TUR-P) were included in the study. The patients were randomly divided into three groups according to the type of local anaesthetic administration: In group N/C (Needle/Catheter), half of the total local anaesthetic dose was administered through touhy needle and the remaining half through epidural catheter.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	60 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	60 Participants n=4 Participants
Region of Enrollment Turkey	20 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	60 Participants n=4 Participants
Age	65.45 years STANDARD_DEVIATION 8.56 • n=5 Participants	61.05 years STANDARD_DEVIATION 9.71 • n=7 Participants	64.20 years STANDARD_DEVIATION 7.01 • n=5 Participants	63.57 years STANDARD_DEVIATION 8.56 • n=4 Participants

PRIMARY outcome

Timeframe: Within 20 minutes after anesthetic administration

Times to reach sensory block T10 (block levels)

Outcome measures

Outcome measures
Measure	Group N n=20 Participants Group N (Needle) Grup C: Local anesthetic was administered through the epidural catheter. Grup N/C: (needle/catheter); half of the local anesthetic was administered through the needle and half through the catheter.	Group C n=20 Participants Group C (Catheter) Grup N: In this study, we used different paths to administer local anesthetic to achieve epidural anesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia and evaluated hemodynamic stability, times to reach sensory block T10, side effects as well as patient and surgeon satisfaction. After 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 path of local anesthetic administration, patients were randomly divided into three groups: Group N (needle); total local anesthetic dose was administered through the Tuohy needle. Grup N/C: (needle/catheter); half of the local anesthetic was administered through the needle and half through the catheter.	Group N/C n=20 Participants Group N/C (Needle/Catheter) Grup N: In this study, we used different paths to administer local anesthetic to achieve epidural anesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia and evaluated hemodynamic stability, times to reach sensory block T10, side effects as well as patient and surgeon satisfaction. After 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 path of local anesthetic administration, patients were randomly divided into three groups: Group N (needle); total local anesthetic dose was administered through the Tuohy needle. Grup C: Local anesthetic was administered through the epidural catheter.
Time to Reach Sensory Block at T10	15.25 Minutes Standard Deviation 1.97	10.50 Minutes Standard Deviation 1.54	11.25 Minutes Standard Deviation 2.22

SECONDARY outcome

Timeframe: From 5 minutes after sedation to 20 minutes after epidural block

Population: All randomized participants (n=60), equally distributed into three groups (n=20 per group), completed the study and were included in the final analysis. No participants were withdrawn or excluded after randomization. The analysis was performed on a per-protocol basis.

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

Outcome measures

Outcome measures
Measure	Group N n=20 Participants Group N (Needle) Grup C: Local anesthetic was administered through the epidural catheter. Grup N/C: (needle/catheter); half of the local anesthetic was administered through the needle and half through the catheter.	Group C n=20 Participants Group C (Catheter) Grup N: In this study, we used different paths to administer local anesthetic to achieve epidural anesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia and evaluated hemodynamic stability, times to reach sensory block T10, side effects as well as patient and surgeon satisfaction. After 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 path of local anesthetic administration, patients were randomly divided into three groups: Group N (needle); total local anesthetic dose was administered through the Tuohy needle. Grup N/C: (needle/catheter); half of the local anesthetic was administered through the needle and half through the catheter.	Group N/C n=20 Participants Group N/C (Needle/Catheter) Grup N: In this study, we used different paths to administer local anesthetic to achieve epidural anesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia and evaluated hemodynamic stability, times to reach sensory block T10, side effects as well as patient and surgeon satisfaction. After 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 path of local anesthetic administration, patients were randomly divided into three groups: Group N (needle); total local anesthetic dose was administered through the Tuohy needle. Grup C: Local anesthetic was administered through the epidural catheter.
Change in Systolic Blood Pressure (SBP) Post-Block 20th Min SBP (mean ± SD)	116.80 mmHg Standard Deviation 16.04	116.40 mmHg Standard Deviation 11.99	121.10 mmHg Standard Deviation 13.50
Change in Systolic Blood Pressure (SBP) Sedation SBP (mean ± SD)	126.70 mmHg Standard Deviation 13.80	123.80 mmHg Standard Deviation 8.61	126.70 mmHg Standard Deviation 13.80

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group N n=20 Participants Group N (Needle) Grup C: Local anesthetic was administered through the epidural catheter. Grup N/C: (needle/catheter); half of the local anesthetic was administered through the needle and half through the catheter.	Group C n=20 Participants Group C (Catheter) Grup N: In this study, we used different paths to administer local anesthetic to achieve epidural anesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia and evaluated hemodynamic stability, times to reach sensory block T10, side effects as well as patient and surgeon satisfaction. After 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 path of local anesthetic administration, patients were randomly divided into three groups: Group N (needle); total local anesthetic dose was administered through the Tuohy needle. Grup N/C: (needle/catheter); half of the local anesthetic was administered through the needle and half through the catheter.	Group N/C n=20 Participants Group N/C (Needle/Catheter) Grup N: In this study, we used different paths to administer local anesthetic to achieve epidural anesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia and evaluated hemodynamic stability, times to reach sensory block T10, side effects as well as patient and surgeon satisfaction. After 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 path of local anesthetic administration, patients were randomly divided into three groups: Group N (needle); total local anesthetic dose was administered through the Tuohy needle. Grup C: Local anesthetic was administered through the epidural catheter.
Maximum Sensory Block Level at the 20th Minute Post-Epidural Block	3.20 Score on a 1-5 scale Standard Deviation 0.52	4.10 Score on a 1-5 scale Standard Deviation 0.55	4.25 Score on a 1-5 scale Standard Deviation 0.54

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group N n=20 Participants Group N (Needle) Grup C: Local anesthetic was administered through the epidural catheter. Grup N/C: (needle/catheter); half of the local anesthetic was administered through the needle and half through the catheter.	Group C n=20 Participants Group C (Catheter) Grup N: In this study, we used different paths to administer local anesthetic to achieve epidural anesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia and evaluated hemodynamic stability, times to reach sensory block T10, side effects as well as patient and surgeon satisfaction. After 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 path of local anesthetic administration, patients were randomly divided into three groups: Group N (needle); total local anesthetic dose was administered through the Tuohy needle. Grup N/C: (needle/catheter); half of the local anesthetic was administered through the needle and half through the catheter.	Group N/C n=20 Participants Group N/C (Needle/Catheter) Grup N: In this study, we used different paths to administer local anesthetic to achieve epidural anesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia and evaluated hemodynamic stability, times to reach sensory block T10, side effects as well as patient and surgeon satisfaction. After 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 path of local anesthetic administration, patients were randomly divided into three groups: Group N (needle); total local anesthetic dose was administered through the Tuohy needle. Grup C: Local anesthetic was administered through the epidural catheter.
Motor Block Intensity Based on Bromage Score at 20 Minutes	0.30 Score on a 0-3 scale Standard Deviation 0.66	0.60 Score on a 0-3 scale Standard Deviation 1.00	0.20 Score on a 0-3 scale Standard Deviation 0.62

SECONDARY outcome

Timeframe: 60 minutes after epidural block administration

Population: All randomized participants (n=60), equally distributed into three groups (n=20 per group), completed the study and were included in the final analysis. No participants were withdrawn or excluded after randomization. The analysis was performed on a per-protocol basis.

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.

Outcome measures

Outcome measures
Measure	Group N n=20 Participants Group N (Needle) Grup C: Local anesthetic was administered through the epidural catheter. Grup N/C: (needle/catheter); half of the local anesthetic was administered through the needle and half through the catheter.	Group C n=20 Participants Group C (Catheter) Grup N: In this study, we used different paths to administer local anesthetic to achieve epidural anesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia and evaluated hemodynamic stability, times to reach sensory block T10, side effects as well as patient and surgeon satisfaction. After 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 path of local anesthetic administration, patients were randomly divided into three groups: Group N (needle); total local anesthetic dose was administered through the Tuohy needle. Grup N/C: (needle/catheter); half of the local anesthetic was administered through the needle and half through the catheter.	Group N/C n=20 Participants Group N/C (Needle/Catheter) Grup N: In this study, we used different paths to administer local anesthetic to achieve epidural anesthesia in patients scheduled for transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia and evaluated hemodynamic stability, times to reach sensory block T10, side effects as well as patient and surgeon satisfaction. After 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 path of local anesthetic administration, patients were randomly divided into three groups: Group N (needle); total local anesthetic dose was administered through the Tuohy needle. Grup C: Local anesthetic was administered through the epidural catheter.
Degree of Sensory Block Regression at 60 Minutes Post-Epidural Block	2.3 Score on a 1-3 scale Standard Deviation 0.47	2.8 Score on a 1-3 scale Standard Deviation 0.86	2.5 Score on a 1-3 scale Standard Deviation 0.61

Adverse Events

Group N

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group N/C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Emine Ozcan

Başakşehir Çam and Sakura City Hospital

Phone: 05301592856

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place