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| ID | Type | Description | Link |
|---|---|---|---|
| Corresponding Author | Other Identifier | Başakşehir Cam and Sakura City Hospital |
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| Name | Class |
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| Ankara City Hospital Bilkent | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group N | Active Comparator | Group N (Needle) |
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| Group C | Active Comparator | Group C (Catheter) |
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| Group N/C | Active Comparator | Group N/C (Needle/Catheter) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural injection via Tuohy needle | Procedure | Local anesthetic was administered entirely through the Tuohy needle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Sensory Block at T10 | Times to reach sensory block T10 (block levels) | Within 20 minutes after anesthetic administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Male patients undergoing transurethral prostatic resection
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| Name | Affiliation | Role |
|---|---|---|
| NERMİN GÖĞÜŞ, Prof.Dr. | Ankara City Hospital Bilkent | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Numune Education and Research Hospital | Ankara | Altındağ | 06080 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23903267 | Background | 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. | |
| 23741568 | 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. |
| Label | URL |
|---|---|
| jscimedcentral | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| https://www.jscimedcentral.com | Clinical Study Report | View IPD |
All results
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All researchers can access all information.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Group C |
| Title | Milestones | Reasons Not Completed | |||||
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| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
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| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2010 | May 23, 2025 |
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| Epidural injection via catheter | Procedure | Local anesthetic was administered entirely through the epidural catheter. |
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| Combined epidural injection (needle and catheter) | Procedure | Half of the total local anesthetic dose was administered through the needle and half through the catheter. |
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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 | Motor block was assessed using the modified Bromage scale: 0 = No motor block
| 20 minutes after epidural block administration |
| Degree of Sensory Block Regression at 60 Minutes Post-Epidural Block | 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 |
| 12760972 | 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. |
| 15264734 | 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. |
| 15278539 | 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. |
| 2650896 | 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. |
| 18633056 | 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. |
| 16244020 | 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. |
| 20434097 | 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. |
| 1466461 | 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. |
| Background | Bernstein S, Malhotra V. Regional anesthesia for genitourinary surgery. In Malhotra V (ed): Anesthesia for Renal And Genitourinary |
| 7818424 | 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. |
| Background | Morgan GE, Mikhail MS, Murray MJ, Larson CP. Regional Anesthesia &Pain Management, Clinical Anesthesiology. 3rd edition. Los Angeles: |
| 15554749 | 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. |
Int J Clin Anesthesiol 4(1): 1050 (2016) |
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.
| FG002 | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group N (Needle) | 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. |
| BG001 | Group C (Catheter) | 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. |
| BG002 | Group N/C (Needle/Catheter) | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Age | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Time to Reach Sensory Block at T10 | Times to reach sensory block T10 (block levels) | Posted | Mean | Standard Deviation | Minutes | Within 20 minutes after anesthetic administration |
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| Secondary | Change in Systolic Blood Pressure (SBP) | Change in Systolic Blood Pressure from Sedation to 20 Minutes Post-Epidural Block | 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. | Posted | Mean | Standard Deviation | mmHg | From 5 minutes after sedation to 20 minutes after epidural block |
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| Secondary | Maximum Sensory Block Level at the 20th Minute Post-Epidural Block | 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. | Posted | Mean | Standard Deviation | Score on a 1-5 scale | 20 minutes after epidural administration |
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| Secondary | Motor Block Intensity Based on Bromage Score at 20 Minutes | Motor block was assessed using the modified Bromage scale: 0 = No motor block
| Posted | Mean | Standard Deviation | Score on a 0-3 scale | 20 minutes after epidural block administration |
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| Secondary | Degree of Sensory Block Regression at 60 Minutes Post-Epidural Block | 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. | 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. | Posted | Mean | Standard Deviation | Score on a 1-3 scale | 60 minutes after epidural block administration |
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Eight months
Allergy to drugs, Intravenous administration of drugs, Haemorrhage/bruising/hematoma/infection, Epidural haemorrhage , Puncturing the dura mater, Severe headaches, Blocking at high level, Haemodynamic instability, Cardiac and respiratory arrest, Total spinal nerve blockade following local anesthetic injection. SCTID: 405363008 Local anesthetic block inadequate. SCTID: 405364002
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group N | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | Group C | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Group N/C | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emine Ozcan | Başakşehir Çam and Sakura City Hospital | 05301592856 | dr.emine3419@gmail.com |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009339 | Needles |
| D057785 | Catheters |
| ID | Term |
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| D004864 | Equipment and Supplies |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| The aim of this analysis is to compare the three groups in terms of patient and surgeon satisfaction using a superiority approach. The null hypothesis is that there is no difference in satisfaction scores between the groups. Statistical significance was set at p < 0.05. | Kruskal-Wallis | >0.05 | No adjustment for multiple comparisons was applied. Non-parametric method used due to ordinal scale structure. | Mean Difference (Final Values) | 0 | Standard Deviation | 0 | 2-Sided | 95 | 0 | 0 | Patient and surgeon satisfaction were compared across study arms. | Superiority |
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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.
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