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Completed

NCT Number: NCT06847620

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

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.

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Key information

Conditions

Hand Surgery

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Hospitals

Cairo, 11111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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

Primary outcomes

  1. Primary outcome measure

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

    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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Evaluation of the Effect of Verapamil When Added to Bupivacaine in Ultrasound-guided Supraclavicular Block in Hand Surgeries

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2025
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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