Epidural Analgesia, Epidural Catheter, Geriatric Cardiology, Hemodynamic (MAP) Stability, Pain Management, Urologic Disorders
Conditions
Keywords
Transurethral resection of the prostate, epidural anesthesia
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.
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.
Interventions
PROCEDUREEpidural injection via Tuohy needle
Local anesthetic was administered entirely through the Tuohy needle.
PROCEDUREEpidural injection via catheter
Local anesthetic was administered entirely through the epidural catheter.
PROCEDURECombined epidural injection (needle and catheter)
Half of the total local anesthetic dose was administered through the needle and half through the catheter.
Sponsors
Ankara City Hospital Bilkent
Başakşehir Çam & Sakura City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Sensory Block at T10 | Within 20 minutes after anesthetic administration | Times to reach sensory block T10 (block levels) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) | From 5 minutes after sedation to 20 minutes after epidural block | Change in Systolic Blood Pressure from Sedation to 20 Minutes Post-Epidural Block |
| Maximum Sensory Block Level at the 20th Minute Post-Epidural Block | 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. |
| Motor Block Intensity Based on Bromage Score at 20 Minutes | 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. |
| Degree of Sensory Block Regression at 60 Minutes Post-Epidural Block | 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. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| 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. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total | Group N/C (Needle/Catheter) | Group C (Catheter) | Group N (Needle) |
|---|---|---|---|---|
| Age | 63.57 years STANDARD_DEVIATION 8.56 | 64.20 years STANDARD_DEVIATION 7.01 | 61.05 years STANDARD_DEVIATION 9.71 | 65.45 years STANDARD_DEVIATION 8.56 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 20 Participants | 20 Participants | 20 Participants |
| Region of Enrollment Turkey | 60 Participants | 20 Participants | 20 Participants | 20 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 60 Participants | 20 Participants | 20 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Time to Reach Sensory Block at T10
Times to reach sensory block T10 (block levels)
Time frame: Within 20 minutes after anesthetic administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group N | Time to Reach Sensory Block at T10 | 15.25 Minutes | Standard Deviation 1.97 |
| Group C | Time to Reach Sensory Block at T10 | 10.50 Minutes | Standard Deviation 1.54 |
| Group N/C | Time to Reach Sensory Block at T10 | 11.25 Minutes | Standard Deviation 2.22 |
Comparison: Sixty male patients scheduled for TURP surgery were divided into three equal groups. The results were evaluated at a 95% confidence interval, with significance set at p \< 0.05. This was achieved using SPSS 15.0. Between-group comparisons were performed using One-way ANOVA, Kruskal-Wallis, Wilcoxon Signed Ranks, and Friedman tests. Within-group comparisons used Wilcoxon Signed Ranks tests, and Friedman tests were used for differences over time.p-value: 0.0595% CI: [10, 20]Kruskal-Wallis
Comparison: 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.p-value: >0.0595% CI: [0, 0]Kruskal-Wallis
Secondary
Change in Systolic Blood Pressure (SBP)
Change in Systolic Blood Pressure from Sedation to 20 Minutes Post-Epidural Block
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group N | Change in Systolic Blood Pressure (SBP) | Sedation SBP (mean ± SD) | 126.70 mmHg | Standard Deviation 13.8 |
| Group N | Change in Systolic Blood Pressure (SBP) | Post-Block 20th Min SBP (mean ± SD) | 116.80 mmHg | Standard Deviation 16.04 |
| Group C | Change in Systolic Blood Pressure (SBP) | Sedation SBP (mean ± SD) | 123.80 mmHg | Standard Deviation 8.61 |
| Group C | Change in Systolic Blood Pressure (SBP) | Post-Block 20th Min SBP (mean ± SD) | 116.40 mmHg | Standard Deviation 11.99 |
| Group N/C | Change in Systolic Blood Pressure (SBP) | Sedation SBP (mean ± SD) | 126.70 mmHg | Standard Deviation 13.8 |
| Group N/C | Change in Systolic Blood Pressure (SBP) | Post-Block 20th Min SBP (mean ± SD) | 121.10 mmHg | Standard Deviation 13.5 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group N | Degree of Sensory Block Regression at 60 Minutes Post-Epidural Block | 2.3 Score on a 1-3 scale | Standard Deviation 0.47 |
| Group C | Degree of Sensory Block Regression at 60 Minutes Post-Epidural Block | 2.8 Score on a 1-3 scale | Standard Deviation 0.86 |
| Group N/C | Degree of Sensory Block Regression at 60 Minutes Post-Epidural Block | 2.5 Score on a 1-3 scale | Standard Deviation 0.61 |
p-value: <0.0595% CI: [0.07, 0.93]Kruskal-Wallis
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.
Time frame: 20 minutes after epidural administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group N | Maximum Sensory Block Level at the 20th Minute Post-Epidural Block | 3.20 Score on a 1-5 scale | Standard Deviation 0.52 |
| Group C | Maximum Sensory Block Level at the 20th Minute Post-Epidural Block | 4.10 Score on a 1-5 scale | Standard Deviation 0.55 |
| Group N/C | Maximum Sensory Block Level at the 20th Minute Post-Epidural Block | 4.25 Score on a 1-5 scale | Standard Deviation 0.54 |
p-value: 0.0595% CI: [0.5, 1.6]Kruskal-Wallis
Secondary
Motor Block Intensity Based on Bromage Score at 20 Minutes
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.
Time frame: 20 minutes after epidural block administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group N | Motor Block Intensity Based on Bromage Score at 20 Minutes | 0.30 Score on a 0-3 scale | Standard Deviation 0.66 |
| Group C | Motor Block Intensity Based on Bromage Score at 20 Minutes | 0.60 Score on a 0-3 scale | Standard Deviation 1 |
| Group N/C | Motor Block Intensity Based on Bromage Score at 20 Minutes | 0.20 Score on a 0-3 scale | Standard Deviation 0.62 |