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

NCT06847620 | Completed Phase 4 DMC

• 1 other identifier: FMASU MS165/2024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hand Surgery

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure

  Duration between performing the block and the need of rescue analgesia in patients receiving ultrasound-guided supraclavicular Brachial plexus block with bupivacaine as sole agent versus bupivacaine and verapamil.

  The duration from giving the block till the need of rescue analgesia in post op 24 hours

Study Arms (2)

• Group A (the control group)

ACTIVE COMPARATOR

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

Procedure: Supraclavicular Brachial Plexus Block; Drug: Bupivacaine 0.25% 20ml alone

Group B

ACTIVE COMPARATOR

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

Procedure: Supraclavicular Brachial Plexus Block; Drug: bupivacaine 0.25% And verapamil

Interventions

Supraclavicular Brachial Plexus Block 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.

Group B; • Group A (the control group)

Bupivacaine 0.25% 20ml alone DRUG

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

• Group A (the control group)

bupivacaine 0.25% And verapamil DRUG

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

Group B

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11111, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Single Person; Verapamil

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: February 26, 2025
• Study Start: March 1, 2024
• Primary Completion: September 4, 2024
• Study Completion: October 15, 2024
• Last Updated: February 26, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before 2/2025
• Access Criteria: Free

Locations

EG (1)