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

October 4, 2024 updated by: Shushma K C, National Academy of Medical Sciences, Nepal

Comparative Study on Fractionated Versus Bolus Dose of Hyperbaric Bupivacaine in Patients Undergoing Transurethral Resection of Prostate Surgery Under Subarachnoid Block.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
      • Kathmandu, Nepal, +977
        • National Academy of Medical Sciences, Bir Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fractionated group arm
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.
Combination product: 0.5% Heavy Bupivacaine
There are two groups.
Other Names:
  • 26 G Quincke's needle
Placebo Comparator: Bolus arm group
In this group ,participants are given Injection Heavy Bupivacaine 0.5% 2.5ml bolus at a rate of 0.2ml/hr
Combination product: 0.5% Heavy Bupivacaine
There are two groups.
Other Names:
  • 26 G Quincke's needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparision of mean arterial pressure(MAP) in both participants with subarachnoid block
Time Frame: Throughout study completion,an average of 3 months
Hypotension was defined when mean arterial pressure (MAP) decreased ≤20% from baseline.
Throughout study completion,an average of 3 months
Comparision of heart rate in both participants with subarachnoid block
Time Frame: Throughout study completion,an average of 3 months
Bradycardia was defined when heart rate is less than 60 beats per minute.
Throughout study completion,an average of 3 months
Comparision of total consumption of vasopressors used during intraoperative period between the groups.
Time Frame: Throughout study completion,an average of 3 months
Injection Mephentermine 6mg iv was given for hypotension
Throughout study completion,an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparision of adverse effects like nausea, vomiting and shivering between the groups
Time Frame: Throughout study completion,an average of 3 months.
Side effects managed according to hospital protocol
Throughout study completion,an average of 3 months.
Comparision of time for onset of sensory between the groups.
Time Frame: Throughout study completion,an average of 3 months.
Sensory block was assessed by loss of sensation to pinprick with blunted tip needle bilaterally in the dermatomal levels. It was tested every 3 min until achievement of maximum sensory block i.e. till T10 level
Throughout study completion,an average of 3 months.
Comparision of time for onset of motor block between the groups
Time Frame: Throughout study completion,an average of 3 months.
Time required to reach Modified Bromage scale =3, where Bromage 0= no motor block ,Bromage 3= complete block of motor limb
Throughout study completion,an average of 3 months.
Comparision of the time of regression of sensory block between two groups.
Time Frame: Throughout study completion,an average of 3 months
Loss of pinprick sensation every 30 minutes postoperatively until it reached the S2 segment
Throughout study completion,an average of 3 months
Comparision of the time of regression motor block between two groups.
Time Frame: Throughout study completion,an average of 3 months.
Assessed every 30 minutes postoperatively Time required to reach Modified Bromage scale =0, where Bromage 0= no motor block ,Bromage 3= complete block of motor limb.
Throughout study completion,an average of 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Academy of Medical Sciences, Nepal

Investigators

  • Study Chair: Pusparaj Poudel, MD, National Academy of Medical Sciences,Bir Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 187/2079/80

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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