Epidural CatheterNCT06893809
Epidural Anesthesia for Transurethral Resection of The Prostate
A study testing Epidural injection via Tuohy needle, Epidural injection via catheter and Combined epidural injection (needle and catheter) in people with Epidural Catheter and Epidural Analgesia, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Epidural Catheter, Epidural Analgesia, Geriatric Cardiology
- What is being tested?
- Epidural injection via Tuohy needle, Epidural injection via catheter and Combined epidural injection (needle and catheter)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2010to 30 Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- No vertebral deformity,
- Body Mass Index <30,
- Patients consenting to epidural anaesthesia.
Who cannot join
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Numune Education and Research Hospital
Ankara, Altındağ, 06080
About this study
Official title: Effects of Different Routes of Local Anesthetic Administration in Epidural Anesthesia for Transurethral Resection of The Prostate
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.
Read the 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.
- Conditions
- Epidural Catheter, Epidural Analgesia, Geriatric Cardiology, Urologic Disorders, Hemodynamic (MAP) Stability, Pain Management
- Being tested
- Epidural injection via Tuohy needle, Epidural injection via catheter, Combined epidural injection (needle and catheter)
- Keywords
- Transurethral resection of the prostate, epidural anesthesia
- Medical subject headings
- Urologic Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural injection via Tuohy needleProcedure or surgery
Also called Epidural anesthesia - needle route
Local anesthetic was administered entirely through the Tuohy needle.
Epidural injection via catheterProcedure or surgery
Also called Epidural anesthesia - catheter route
Local anesthetic was administered entirely through the epidural catheter.
Combined epidural injection (needle and catheter)Procedure or surgery
Also called Epidural anesthesia - combined route
Half of the total local anesthetic dose was administered through the needle and half through the catheter.
| Study group | Role | What they receive |
|---|---|---|
| Group N | Active comparator | Group N (Needle) Receives: Procedure: Epidural injection via catheter; Procedure: Combined epidural injection (needle and catheter) |
| Group C | Active comparator | Group C (Catheter) Receives: Procedure: Epidural injection via Tuohy needle; Procedure: Combined epidural injection (needle and catheter) |
| Group N/C | Active comparator | Group N/C (Needle/Catheter) Receives: Procedure: Epidural injection via Tuohy needle; Procedure: Epidural injection via catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Reach Sensory Block at T10
Times to reach sensory block T10 (block levels)
Measured: Within 20 minutes after anesthetic administration
Secondary outcomes (4)
Change in Systolic Blood Pressure (SBP)
Change in Systolic Blood Pressure from Sedation to 20 Minutes Post-Epidural Block
Measured: From 5 minutes after sedation to 20 minutes after epidural block
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.
Measured: 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
- = Partial block (able to move knees and feet)
- = Moderate block (unable to flex knees, able to move feet)
- = 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.
Measured: 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.
Measured: 60 minutes after epidural block administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start2 Jan 2010
- Primary completion30 Nov 2010
- Study completion30 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Epidural CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, Emine OZCAN, Başakşehir Çam & Sakura City Hospital
- Investigators
- NERMİN GÖĞÜŞ, Prof.Dr., Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893809
- Sponsor's protocol ID
- ANEAH2010
- Other IDs
- Corresponding Author
- Status last verified
- Jul 2025
- First submitted
- 9 Mar 2025
- Last updated
- 25 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All results
Publications
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.
PubMed 23903267Kim 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.
PubMed 23741568Horlocker 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.
PubMed 12760972Yun 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.
PubMed 15264734Omote 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.
PubMed 15278539Crochetiere 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.
PubMed 2650896Visser 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.
PubMed 18633056Cesur 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.
PubMed 16244020Ulker 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.
PubMed 20434097Sorenson 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.
PubMed 1466461Bernstein 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.
PubMed 7818424Morgan 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.
PubMed 15554749
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Routes of Local Anesthetic Administration in Epidural Anesthesia for Transurethral Resection of The Prostate
- ClinicalTrials.gov ID
- NCT06893809
- Acronym / sponsor ID
- ANEAH2010
- Conditions
- Epidural Catheter, Epidural Analgesia, Geriatric Cardiology, Urologic Disorders, Hemodynamic (MAP) Stability, Pain Management
- Keywords
- Transurethral resection of the prostate, epidural anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 2 Jan 2010 (actual)
- Primary completion
- 30 Nov 2010 (actual)
- Study completion
- 30 Dec 2010 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Posted 25 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group N | Active comparator | Procedure: Epidural injection via catheter, Procedure: Combined epidural injection (needle and catheter)Group N (Needle) |
| Group C | Active comparator | Procedure: Epidural injection via Tuohy needle, Procedure: Combined epidural injection (needle and catheter)Group C (Catheter) |
| Group N/C | Active comparator | Procedure: Epidural injection via Tuohy needle, Procedure: Epidural injection via catheterGroup N/C (Needle/Catheter) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male undergoing transurethral prostatic resection,
- 40 to 75 years old,
- ASA-I-III
- Not using anticoagulants or antiaggregants,
- No peripheral neuropathy or muscle disease,
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural injection via Tuohy needleAlso: Epidural anesthesia - needle routeLocal anesthetic was administered entirely through the Tuohy needle. | Procedure or surgery | Group C, Group N/C |
| Epidural injection via catheterAlso: Epidural anesthesia - catheter routeLocal anesthetic was administered entirely through the epidural catheter. | Procedure or surgery | Group N, Group N/C |
| Combined epidural injection (needle and catheter)Also: Epidural anesthesia - combined routeHalf of the total local anesthetic dose was administered through the needle and half through the catheter. | Procedure or surgery | Group C, Group N |
Primary outcome
Time to Reach Sensory Block at T10
Time frame: Within 20 minutes after anesthetic administration
Times to reach sensory block T10 (block levels)
4 secondary outcomes
Change in Systolic Blood Pressure (SBP)
Time frame: From 5 minutes after sedation to 20 minutes after epidural block
Maximum Sensory Block Level at the 20th Minute Post-Epidural Block
Time frame: 20 minutes after epidural administration
Motor Block Intensity Based on Bromage Score at 20 Minutes
Time frame: 20 minutes after epidural block administration
Degree of Sensory Block Regression at 60 Minutes Post-Epidural Block
Time frame: 60 minutes after epidural block administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23903267Barbosa 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.
- Background: PubMed 23741568Kim 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.
- Background: PubMed 12760972Horlocker 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.
- Background: PubMed 15264734Yun 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.
- Background: PubMed 15278539Omote 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.
- Background: PubMed 2650896Crochetiere 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.
- Background: PubMed 18633056Visser 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.
- Background: PubMed 16244020Cesur 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.
- Background: PubMed 20434097Ulker 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.
- Background: PubMed 1466461Sorenson 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.
- BackgroundBernstein S, Malhotra V. Regional anesthesia for genitourinary surgery. In Malhotra V (ed): Anesthesia for Renal And Genitourinary
- Background: PubMed 7818424Blake 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.
- jscimedcentralLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NERMİN GÖĞÜŞ, Prof.Dr. study chair
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural injection via Tuohy needle, Epidural injection via catheter and Combined epidural injection (needle and catheter) in people with Epidural Catheter and Epidural Analgesia, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Reach Sensory Block at T10 (time frame: Within 20 minutes after anesthetic administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06893809, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.