Effect of Verapamil as an Adjuvant to Local Anaethetics in Supraclav Block for Hand Surgery

NCT ID: NCT06847620

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-10-15

Brief Summary

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The aim of this study is to evaluate the role of verapamil when added to bupivacaine in ultrasound-giuded supraclavicular Brachial plexus block regarding the duration of action of the block, onset of action and the need of rescue analgesia.

Detailed Description

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Preoperative Period All patients will clinically be assessed and routine preoperative investigations will be done: Complete blood picture, Coagulation profile, liver function tests, kidney function tests, fasting blood sugar and ECG. The initial vital data will be measured after applying the standard monitoring including pulse oximetry, non-invasive blood pressure and ECG. All patients will be admitted after fasting for 6 hours.

Intraoperative Period On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied. Baseline parameters such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), and oxygen saturation (SpO2) will be recorded. Intravenous (IV) line will be inserted and IV lactated Ringer will be started.

The block will be performed using a portable ultrasound system (sonosite M-turbo USA) with linear high-frequency transducer (12HZ) to get the sonographic anatomy of brachial plexus in the transverse and longitudinal planes.

Under aseptic conditions, the ultrasound probe will be situated parallel to the clavicle in the supraclavicular area to show the plexus as a "bunch of grapes" or as having a "honeycomb" appearance. The block will be done with a short beveled echogenic needle 5 cm, 22 G for optimal control and visibility. The predetermined volume of 22 ml will be injected around the brachial plexus after negative aspiration to avoid inadvertent intravascular injection keeping in mind adequate block of lower trunk. Distension of brachial plexus sheath will be regarded as an indication of successful block "Donut sign". A massage for 5 min will be applied to aid an equal volume distribution.

Conditions

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Hand Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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• Group A (the control group)

group A: will receive 20 ml of plain bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml of normal saline.

Group Type ACTIVE_COMPARATOR

Supraclavicular Brachial Plexus Block

Intervention Type PROCEDURE

The block will be performed using a portable ultrasound system (sonosite M-turbo USA) with linear high-frequency transducer (12HZ) to get the sonographic anatomy of brachial plexus in the transverse and longitudinal planes.

Bupivacaine 0.25% 20ml alone

Intervention Type DRUG

will receive 20 ml of plain bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml of normal saline.

Group B

Group B : will receive 20 ml of bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml verapamil (equivalent to 5 mg)

Group Type ACTIVE_COMPARATOR

Supraclavicular Brachial Plexus Block

Intervention Type PROCEDURE

The block will be performed using a portable ultrasound system (sonosite M-turbo USA) with linear high-frequency transducer (12HZ) to get the sonographic anatomy of brachial plexus in the transverse and longitudinal planes.

bupivacaine 0.25% And verapamil

Intervention Type DRUG

will receive 20 ml of bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml verapamil (equivalent to 5 mg

Interventions

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Supraclavicular Brachial Plexus Block

The block will be performed using a portable ultrasound system (sonosite M-turbo USA) with linear high-frequency transducer (12HZ) to get the sonographic anatomy of brachial plexus in the transverse and longitudinal planes.

Intervention Type PROCEDURE

Bupivacaine 0.25% 20ml alone

will receive 20 ml of plain bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml of normal saline.

Intervention Type DRUG

bupivacaine 0.25% And verapamil

will receive 20 ml of bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml verapamil (equivalent to 5 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females aged 21-70 years old
* Patients with ASA I / II
* patients undergoing hand surgeries

Exclusion Criteria

* Patients refusal
* Skin infection at the injection site.
* Contraindications to regional anaesthesia as bleeding disorders
* Allergy to bupivacaine or other drugs involved in the study.
* Uncooperative patients.
* BMI \>35
* Patients taking medications for psychiatric illness
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain Shams University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MS165/2024

Identifier Type: -

Identifier Source: org_study_id

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