Comparison of Hemodynamic Effect Between the Spinal Anesthesia and Saddle Block Using Levobupivacaine During Transurethral Resection of the Prostate in Cardiac Elderly Patients

Spinal Anesthesia Clinical Trial

Official title:

Comparison of Hemodynamic Effect Between the Spinal Anesthesia and Saddle Block Using Levobupivacaine During Transurethral Resection of the Prostate in Cardiac Elderly Patients: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014957
• Other study ID #: transurethral resection
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: New Valley University
• Contact: Ahmed Twaisy, MD
• Phone: 01007410757
• Email: Twisy200235[@]med.nvu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transurethral resection of the prostate (TURP) is the most common surgical intervention for patients with benign prostatic hyperplasia. TURP is mostly applied to elderly patients with hypertension and problems with breathing, circulation system, and kidney functions; therefore, it becomes very important to keep a stable anesthesia that will minimize the hemodynamic differences in these patients. General anesthesia causes more hemodynamic differences than regional anesthesia. Thus, regional anesthesia is highly preferable in TURP applications.

Description:

TURP is performed by inserting a resectoscope through the urethra and resecting prostatic tissue with an electrically powered cutting-coagulating metal loop or using laser-22 vaporization energy. This can be accomplished with either a monopolar TURP (M-TURP) or bipolar TURP (B-TURP) technique. Laser energy for TURP has also been used for many years. With each technique, as much prostatic tissue as possible is resected, but the prostatic capsule is usually preserved. If the capsule is violated, large amounts of irrigation solution can be absorbed into the circulation via the periprostatic, retroperitoneal, or peritoneal space. Bleeding during TURP is not uncommon but usually controllable; hemostasis becomes difficult when large venous sinuses are opened. If the bleeding becomes uncontrollable, the procedure should be terminated as quickly as possible, and a Foley catheter should be passed into the bladder and traction applied to it. The catheter's inflated balloon exerts lateral pressure on the prostatic bed and reduces bleeding. Bleeding requiring transfusion occurs in approximately 2.5% of TURP procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) III,
• with Ischemic Heart Disease (history of Myocardial Ischemia,
• a history of a positive treadmill test result (Electro Cardio Graph stress test),
• use of nitroglycerin, chronic stable angina for more than two months, or an ECG with abnormal Q waves), with ejection fraction (EF) 35%-50%,

Exclusion Criteria:

• patients under 65 years,
• patients with any diseases that increase intraabdominal pressure (any intra-abdominal mass),
• general contraindications of spinal anesthesia as patient refusal, coagulation disorders, local infection at the site of the block, psychiatric illness,

Related Conditions & MeSH terms

• Spinal Anesthesia

Intervention

Drug:
• spinal anesthesia
12.5 mg of 0.5% hyperbaric levobupivacaine (2.5 ml) was given at the level of L4-5 interspaces after the free flow confirming of the cerebrospinal fluid (CSF), immediately positioned supine with one pillow supporting the head and shoulders
• saddle block
12.5 mg of 0.5% hyperbaric levobupivacaine (2.5 ml) was given at the level of L4-5 interspaces after the free flow confirming of the cerebrospinal fluid (CSF), placed in the sitting position for ten minutes and then supine with one pillow supporting the head and shoulders

Locations

Country	Name	City	State
Egypt	Ahmed Omar Twaisy	New Cairo	Kharga

Sponsors (1)

Lead Sponsor	Collaborator
New Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Bhattacharyya S, Bisai S, Biswas H, Tiwary MK, Mallik S, Saha SM. Regional anesthesia in transurethral resection of prostate (TURP) surgery: A comparative study between saddle block and subarachnoid block. Saudi J Anaesth. 2015 Jul-Sep;9(3):268-71. doi: 10.4103/1658-354X.158497. — View Citation

Gulec D, Karsli B, Ertugrul F, Bigat Z, Kayacan N. Intrathecal bupivacaine or levobupivacaine: which should be used for elderly patients? J Int Med Res. 2014 Apr;42(2):376-85. doi: 10.1177/0300060513496737. Epub 2014 Mar 4. — View Citation

Rooke GA, Freund PR, Jacobson AF. Hemodynamic response and change in organ blood volume during spinal anesthesia in elderly men with cardiac disease. Anesth Analg. 1997 Jul;85(1):99-105. doi: 10.1097/00000539-199707000-00018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean arterial blood pressure		24 hours