Motor Sparing Supraclavicular Block

NCT06074471 | Recruiting

• 1 other identifier: N-267-2023
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare MS-SCBPB and SCBPB in the duration of postoperative analgesia, time to first analgesic request (VAS ≥40 mm), pain scores, motor power, and side effects.

Conditions

Anesthesia; Regional Anesthesia Morbidity

Keywords

Motor sparing; SCBP block; Upper limb operations

Outcome Measures

Primary Outcomes (1)

• Duration of motor blockade

  Duration of motor blockade

  24 hours

Secondary Outcomes (5)

• Time needed for surgical block:

  24 hours

• Time needed for complete recovery from sensory and motor block at 2, 4, 6, 12, 18, and 24 hours postoperatively.

  24 hours

• Time to first analgesic request

  24 hours

• Visual analogue scale (VAS)

  24 hours

• Total morphine requirements

  24 hours

Study Arms (2)

MS-SCBPB Group (n=22)

EXPERIMENTAL

receive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine (concentration 0.20%) "9 ml Bupivacaine+9ml lignocaine +2ml Dexamethasone 8mg "

Procedure: ultrasound guided supraclavicular brachial plexus block

SCBPB Group (n=22):

ACTIVE COMPARATOR

receive ultrasound-guided supraclavicular brachial plexus block with total volume 20 mL bupivacaine (concentration 0.5%) "18 ml Bupivacaine+2ml Dexamethasone 8mg"

Procedure: ultrasound guided supraclavicular brachial plexus block

Interventions

ultrasound guided supraclavicular brachial plexus block PROCEDURE

Block will be performed in semi-sitting position with head tilted to the opposite side of injection site. linear probe (4-12MHz) (Mindray Digital Ultrasonic Model DP-10 "SN 6N-49005130" 2014-09. SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.LTD) will be placed parallel to the clavicle in the supraclavicular fossa visualizing the subclavian artery is seen beating above the first rib. A volume of 2 mL lignocaine 2% will be infiltrated subcutaneous before the block. A 20-gauge needle will be advanced in plane aiming to the corner pocket towards the deeper portion of the brachial plexus at the angle between the first rib and the subclavian artery, 10 mL of drug will be injected. Then, the needle will be retracted and advanced at a shallower angle, aiming toward the superficial plexus after negative aspiration another 10 ml will be injected, total drug injected 20 ml (18 mL of drug will be injected with addition to 8mg dexamethasone (2ml))

Also known as: Drugs used (bupivacaine and dexamethazone)

MS-SCBPB Group (n=22); SCBPB Group (n=22):

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for upper limb surgeries under supraclavicular brachial plexus block
• American Society of Anesthesiologists (ASA) status I and III
• between ages of 18 and 60 years

You may not qualify if:

• Bleeding disorders with INR \> 1.5 and/or platelets \< 100,000/mm3
• infection at the injection site
• Allergy to local anesthetics
• Severe cardiopulmonary disease (≥ASA IV)
• Diabetic or other neuropathies
• Motor disorders
• Patients receiving opioids for chronic analgesic therapy
• Inability to comprehend visual analogue scale (VAS).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university Hospitals. kasralainy

Cairo, Governorate, 002, Egypt

RECRUITING

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Nagy malak, MD

CONTACT

01552480258; nagymalak@kasralainy.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia ,SICU and pain

Model Details: Drugs used (bupivacaine-lidocaine-Dexamethazone) Rescue analgesic is morphine

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 10, 2023
• Study Start: September 25, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)