Epidural Anesthesia for Transurethral Resection of The Prostate
NCT ID: NCT06893809
Last Updated: 2025-07-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2010-01-02
2010-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group N
Group N (Needle)
Epidural injection via catheter
Local anesthetic was administered entirely through the epidural catheter.
Combined epidural injection (needle and catheter)
Half of the total local anesthetic dose was administered through the needle and half through the catheter.
Group C
Group C (Catheter)
Epidural injection via Tuohy needle
Local anesthetic was administered entirely through the Tuohy needle.
Combined epidural injection (needle and catheter)
Half of the total local anesthetic dose was administered through the needle and half through the catheter.
Group N/C
Group N/C (Needle/Catheter)
Epidural injection via Tuohy needle
Local anesthetic was administered entirely through the Tuohy needle.
Epidural injection via catheter
Local anesthetic was administered entirely through the epidural catheter.
Interventions
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Epidural injection via Tuohy needle
Local anesthetic was administered entirely through the Tuohy needle.
Epidural injection via catheter
Local anesthetic was administered entirely through the epidural catheter.
Combined epidural injection (needle and catheter)
Half of the total local anesthetic dose was administered through the needle and half through the catheter.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
75 Years
MALE
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Başakşehir Çam & Sakura City Hospital
OTHER_GOV
Responsible Party
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Emine OZCAN
Principal Investigator
Principal Investigators
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NERMİN GÖĞÜŞ, Prof.Dr.
Role: STUDY_CHAIR
Ankara City Hospital Bilkent
Locations
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Ankara Numune Education and Research Hospital
Ankara, Altındağ, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Bernstein S, Malhotra V. Regional anesthesia for genitourinary surgery. In Malhotra V (ed): Anesthesia for Renal And Genitourinary
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.
Morgan GE, Mikhail MS, Murray MJ, Larson CP. Regional Anesthesia &Pain Management, Clinical Anesthesiology. 3rd edition. Los Angeles:
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.
Provided Documents
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Document Type: Statistical Analysis Plan
Study Documents
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Related Links
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Other Identifiers
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Corresponding Author
Identifier Type: OTHER
Identifier Source: secondary_id
ANEAH2010
Identifier Type: -
Identifier Source: org_study_id
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