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

A

Ain Shams University

Status and phase

Completed
Phase 4

Conditions

Hand Surgery

Treatments

Drug: Bupivacaine 0.25% 20ml alone
Drug: bupivacaine 0.25% And verapamil
Procedure: Supraclavicular Brachial Plexus Block

Study type

Interventional

Funder types

Other

Identifiers

NCT06847620
FMASU MS165/2024

Details and patient eligibility

About

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.

Full description

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.

Enrollment

32 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

32 participants in 2 patient groups

• Group A (the control group)
Active Comparator group
Description:
group A: will receive 20 ml of plain bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml of normal saline.
Treatment:
Procedure: Supraclavicular Brachial Plexus Block
Drug: Bupivacaine 0.25% 20ml alone
Group B
Active Comparator group
Description:
Group B : will receive 20 ml of bupivacaine 0.25% (equivalent to 50 mg) plus 2 ml verapamil (equivalent to 5 mg)
Treatment:
Procedure: Supraclavicular Brachial Plexus Block
Drug: bupivacaine 0.25% And verapamil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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