Comparative Study Between the Effect of Ultrasound Guided Median Nerve Block , Radial Nerve Block and Local Infiltration on Feasibility of Radial Artery Cannulation

NCT05459792 | Unknown

• 1 other identifier: N-52-2022
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

Brief Summary

Arterial line placement is often needed in various critical care settings. It is a basic procedure performed for continuous blood pressure (BP) monitoring and rapid access for repeated arterial blood gas samples, as it is considered to be more precise than measurement of BP by other noninvasive devices, especially in the critically ill patients or those on continuous infusions of vasoactive drugs.Arterial line placement is presumed to be a relatively safe procedure, with a rate of major complications that is below 1%. The most common site of cannulation is the radial artery, primarily due to the ease of access owing to the superficial nature of the vessel and the ease with which the site can be maintained. Additional advantages of radial artery cannulation include anatomical reliability and the less complications. However placement of a radial artery catheter can, at times, be difficult because many patients who emergently need a catheter may have a weak arterial pulse due to dehydration or blood loss or may have some form of peripheral vascular disease. Although it is usually a well-tolerated procedure, it is considered more painful than intravenous (i.v.) cannula placement, particularly in case of multiple attempts of cannulation In this study the investigators will assess the effect of ultrasound guided median nerve block, radial nerve block and local infiltration with lidocaine on feasibility of radial artery cannulation in patients undergoing major surgeries Objectives

1. 1.To evaluate the effect of ultrasound guided median nerve block, radial nerve block and local infiltration on feasibility of radial artery cannulation
2. 2.To determine the effect of ultrasound guided median nerve block, radial nerve block and local infiltration in reducing discomfort and complicationassociated with radial arterial cannulation .

Conditions

Radial Artery Cannulation

Outcome Measures

Primary Outcomes (1)

• The time to successful radial arterial cannulation

  It is measured from the initial needle penetration through the skin to removal of the metal needle and continuation of a flash of arterial blood in seconds

  It will be measured from the initial needle penetration through the skin to removal of the metal needle and continuation of a flash of arterial blood in seconds at base line (15 minutes )before surgery

Secondary Outcomes (1)

• Incidence of post cannulation complication such as arterial spasm , ischemia ,thrombosis and hematoma formation in the first 24 hours postoperative

  It will be measured in the first 24 hours postoperative

Study Arms (3)

ultrasound guided median nerve block

EXPERIMENTAL

A linear transducer will be placed on the ventral aspect of the mid-forearm, where the median nerve is visible in the fascial plane between the flexor digitorum superficialis and flexor digitorum profundus after raising a skin wheal using local anesthetic, the needle will be introduced in-plane view from lateral to medial and aimed at the fascial plane adjacent to the median nerve.

Procedure: median nerve block

ultrasound guided radial nerve block

EXPERIMENTAL

A linear transducer will be placed on the forearm: at the elbow (the radial nerve between the brachioradialis and the biceps muscle). the preferred approach is to start proximally above the elbow and identify the radial nerve as a triangular hyperechoic structure coming off the distal humerus. then following this distally to the antecubital fossa, where the nerve will branch into its superficial and deep branches. the needle will be introduced in-plane view from lateral to medial aimed at the fascial plane adjacent to the radial nerve.

Procedure: radial nerve block

local infiltration

PLACEBO COMPARATOR

Intradermal infiltration followed by a subcutaneous injection with a total of 3 mL of 0.25% bupivacaine with1% lidocaine with a27- G needle.

Procedure: local infiltration

Interventions

median nerve block PROCEDURE

It will be given by one researcher using 5 ml 0.25% bupivacaine with 1% lidocaine for each nerve block after negative aspiration for blood so as to cover the nerve circumferentially

Also known as: peripheral nerve block

ultrasound guided median nerve block

radial nerve block PROCEDURE

It will be given by one researcher using 5 ml 0.25% bupivacaine with 1% lidocaine for each nerve block after negative aspiration for blood so as to cover the nerve circumferentially

Also known as: peripheral nerve block

ultrasound guided radial nerve block

local infiltration PROCEDURE

intradermal infiltration followed by a subcutaneous injection with a total of 3 mL of 0.25% bupivacaine with1% lidocaine with a27- G needle

Also known as: bupivacaine and lidocaine infiltration

local infiltration

Eligibility Criteria

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

You may qualify if:

• Gender both males and females
• ASA Class II
• Age 18-70 years
• Patients undergoing surgeries requiring radial arterial cannulation expected to be needed , and in place for the first 24 hours postoperatively as thoracic surgeries(e,g lobectomy, pneumonectomy),major vascular surgeries (carotid end arterctomy,abdominal aneurysm) , or major abdominal surgery .

You may not qualify if:

• Hypersensitivity or knownallergy to amide local anesthetics
• Pre-existing neurological deficit/peripheral neuropathy and Coagulation disorders.
• Local infection at the site of block and at the planned cannulation site.
• peripheral occlusive vascular disease, surgery for vascular injury or thromboembolic phenomena, cervical rib, and conditions associated with obstruction to arterial or venous flow.
• Emergency operations and occlusion of the ipsilateral ulnar artery
• patients on vasopressors and radial artery cannula removal before 24 hours postoperative.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (2)

Kasr Al Ainy

Cairo, 202, Egypt

RECRUITING

Kasr Alainy, Cairo University

Cairo, 202, Egypt

RECRUITING

MeSH Terms

Interventions

Anesthesia, Local; Bupivacaine

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Amr ahmed abdel kader, lecturer

  Anesthesia department , Cairo university

  STUDY DIRECTOR

Central Study Contacts

Ahmed nabih, lecturer

CONTACT

01002773488; nabihomar100@yahoo.com

mohamed abdel ghany, lecturer

CONTACT

01016109777; dr.mohmed.elshazly8686@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done by computer generated numbers and concealed by serially numbered, opague and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. This study will be performed by 2 anaesthetists; one anaesthetist who is experienced in performing the blocks will be allocated to perform either the median or radial or local infiltration according to a computer-generated sequence of random numbers and sealed envelope, and the other anesthetist who is experienced in performing ultrasound examinations and radial cannulation, will be blinded to the technique performed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: July 18, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

EG (2)