Study to compare Bupivacaine heavy, Levobupivacaine plain and Levobupivacaine heavy with Fentanyl (opioid) as an add on drug under spinal anesthesia in Prostate surgery.

Phase 4

Not yet recruiting

• Conditions: Benign prostatic hyperplasia withlower urinary tract symptoms,

• Registration Number: CTRI/2023/06/054367
• Lead Sponsor: Dr Sanyukta Paul

Brief Summary

This is a prospective randomized study comparing low dose intrathecal Levobupicaine 0.5% heavy, Levobupivacaine 0.5% plain and Bupivacaine 0.5% heavy with Fentanyl as an adjuvant in Transurethral resection of prostate surgeries. In this study, we are comparing the onset and duration of motor block and sensory block, to study intraoperative hemodynamics and to study the untoward side effects,if any.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-07
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 105

Inclusion Criteria

Patient giving consent to participate in study Age between 50-75 years Weight between 45-70 kg ASA grade I and II Patient scheduled for TURP surgeries.

Exclusion Criteria

• Patients not giving consent to participate in the study.
• Uncooperative patient ASA grade III and IV Patients with respiratory, cardiovascular, renal diseases, obesity.
• Neurological disease (multiple sclerosis, symptomatic lumbar herniated disc, spinal stenosis) Coagulopathy Patient with known hypersensitivity to local anaesthetic.
• Local sepsis or infection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected prolonged efficacy of Levobupivacaine 0.5% heavy over Bupivacaine 0.5% heavy & Levobupivacaine 0.5% plain	24 hours

Secondary Outcome Measures

Name	Time	Method
Expected lesser side effects & stable hemodynamic profile with Levobupivacaine 0.5% heavy than Bupivacaine 0.5% heavy and Levobupivacaine 0.5% plain	24 hours

Trial Locations

Locations (1)

Gajraraja Medical College and Jayarogya Hospital, Gwalior; 🇮🇳 Gwalior, MADHYA PRADESH, India

Gajraraja Medical College and Jayarogya Hospital, Gwalior

🇮🇳Gwalior, MADHYA PRADESH, India

DrSanyukta Paul

Principal investigator

8827430031

sanyuktasaivikash@gmail.com