A 3 Months Duration Interventional Study Comparing Hemodynamic Parameters Between Bolus and Fractionated Group.

National Academy of Medical Sciences, Nepal

Status and phase: Completed; Phase 1

Conditions: Prostatic Hyperplasia, Benign

Treatments: Combination Product: 0.5% Heavy Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06620614

187/2079/80

Details and patient eligibility

About

The goal of this study is to compare the intraoperative hemodynamic status, characteristics of block of fractionated versus single bolus dose of Hyperbaric Bupivacaine in patient undergoing Transurethral Resection of Prostate(TURP) surgery under Subarachnoid block(SAB).

Seventy-two patients aged 50 years and above belonging to American Physical status I and II are divided into two study group.

Group B will receive Injection 0.5 % hyperbaric bupivacaine 2.5 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially (i.e. 1.6 ml) and remaining one third dose (i.e. 0.9 ml) after 60 seconds at the rate of 0.2ml/sec.

Full description

The aim of this study is to compare the intraoperative hemodynamic status, characteristics of block of fractionated versus single bolus dose of Hyperbaric Bupivacaine in patient undergoing TURP surgery under SAB.

Seventy-two patients aged 50 years and above belonging to American Physical status I and II undergoing transurethral resection of prostate for benign enlargement of prostate under subarachnoid block are enrolled and are divided into two groups having 36 patients in each.

Group B will receive Injection 0.5 % hyperbaric bupivacaine 2.5 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially (i.e. 1.6 ml) and remaining one third dose (i.e. 0.9 ml) after 60 seconds at the rate of 0.2ml/sec.

Intraoperative mean arterial pressure (MAP), heart rate, onset of sensory and motor block, duration of sensory and motor block, and total intraoperative consumption of vasopressor are observed and compared between the groups.

Enrollment: 72 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 50 years and above patients undergoing TURP surgery under SAB
• American Society of Anesthesiologist's Physical Status: I and II.

Exclusion criteria

• Patients with history of uncontrolled hypertension.
• Patients with previous history of cerebrovascular accidents.
• Patients with history of spinal deformity.
• Patients with known allergy to local anesthetics.
• Patient with Infection at site of injection.
• Patient with history of coagulopathy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups, including a placebo group

Fractionated group arm

Experimental group

Description:

In this group ,participants are given 1.6 ml of Injection Heavy Bupivacaine 0.5% initially followed by 0.9ml after 60 seconds at a rate of 0.2ml/hr.

Treatment:

Combination Product: 0.5% Heavy Bupivacaine

Bolus arm group

Placebo Comparator group

Description:

In this group ,participants are given Injection Heavy Bupivacaine 0.5% 2.5ml bolus at a rate of 0.2ml/hr

Treatment:

Combination Product: 0.5% Heavy Bupivacaine