Clinical trial NCT06893809: Epidural Anesthesia for Transurethral Resection of The Prostate
Official title: Effects of Different Routes of Local Anesthetic Administration in Epidural Anesthesia for Transurethral Resection of The Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Catheter
Epidural Analgesia
Geriatric Cardiology
Urologic Disorders
Hemodynamic (MAP) Stability
Pain Management
Keywords: Transurethral resection of the prostate
epidural anesthesia
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Ankara Bilkent Sehir Hastanesi
First posted: 2025-03-25
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Level of sensory block required for surgery
timeFrame: 10 minutes after anesthesia administration
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Numune Education and Research Hospital
state: Altındağ
Study officials:
affiliation: Ankara City Hospital Bilkent
name: NERMİN GÖĞÜŞ, Prof.Dr.
role: STUDY_CHAIR
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