The Efficacy of Intravenous Dexamethasone on the Duration of Analgesia of Ultrasound Guided Axillary Brachial Plexus Block in Pediatric Patients Undergoing Below Elbow Orthopaedic Surgeries

NCT05466500 | Unknown

• 1 other identifier: N-53-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is a common manifestation in orthopedic patients, mainly due to intraoperative tissue damage , inadequate intraoperative pain assessment and management. Axillary nerve block provides motor and sensory block with the distribution of the median, radial, ulnar and musculocutaneous branches so it can be conducted with upper limb orthopedic surgery in hand, rest and elbow surgery distal to the cubital fossa.Sensory blockade of the brachial plexus for perioperative analgesia leads to stable haemodynamics intraoperatively, smoother emergence from general anaesthesia and decreased need for supplemental analgesics or suppositories in the Post-operative period Intravenous (IV) dexamethasone has been used as an additive to local anesthetic for peripheral nerve blocks (PNBs) in adults with variable efficacy.To the best of our knowledge the efficacy of intravenous dexamethasone as adjuvant to bupivacaine in ultrasound guided axillary brachial plexus block in pediatrics has not been investigated In this study the investigators will assess the analgesic effect of adding intravenous dexamethasone to bupivacaine in ultrasound guided axillary block in children undergoing upper limb orthopedic surgeries. Objectives:

• To determine the effect of adding intravenous dexamethasone on the duration of analgesia .
• To determine the effect of adding intravenousdexamethasone on quality of analgesia

Conditions

Axillary Brachial Plexus Block

Outcome Measures

Primary Outcomes (1)

• Time to first request of opioid analgesia

  Time to first request of opioid analgesia will be"the time interval between LA injection and the first request to postoperative analgesia (first dose of pethidine adminstration)" (minutes)

  it will be measured in the first 24 hours postoperative

Secondary Outcomes (1)

• Total opioid consumption 24 hours postoperative

  It will be measured in the first 24 hours postoperative

Study Arms (2)

Ultrasound guided axillary block with intravenous dexamethasone

ACTIVE COMPARATOR

The probe will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles .The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked and use of intravenous dexamethasone as an adjuvant to bupivacaine for Post-operative analgesia following sensory blockade of the axillary brachial plexus in paediatrics undergoing below elbow orthopaedic surgeries.

Procedure: Ultrasound guided axillary block with intravenous dexamethasone

Ultrasound guided axillary block

PLACEBO COMPARATOR

The probe will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identifythe hyperechoic median, ulnar, and radial nervesin relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles .The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked

Procedure: Ultrasound guided axillary block

Interventions

Ultrasound guided axillary block with intravenous dexamethasone PROCEDURE

it will be given by one researcher using 2 mg/kg of 0.25% bupivacaine plus 0.1mg/kg dexamethasone intravenous

Also known as: peripheral nerve block with dexamethasone, bupivacaine and dexamethasone intravenous

Ultrasound guided axillary block with intravenous dexamethasone

Ultrasound guided axillary block PROCEDURE

it will be given by one researcher using 2 mg/kg of 0.25% bupivacaine

Also known as: peripheral nerve block, bupivacaine only

Ultrasound guided axillary block

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gender both males and females
• ASA ClassI-II
• Age 4-14 years
• Patients under going upper limb orthopaedic surgery in the hand, wrist, and elbow distal to the cubital fossa

You may not qualify if:

• Parent refusal.
• Patients with apparent infection at site of needle insertion.
• Patients with any coagulation disorder(Platelets ≤ 50,000 and/or INR\> 1.5)
• Patients with known neuropathy or brachial plexus injury.
• Patient with known sensitivity to local anesthetic drugs

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Dexamethasone; Bupivacaine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ahmed nabih, lecturer

  Anesthesia department , Cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed nabih, lecturer

CONTACT

01002773488; nabihomar100@yahoo.com

Abdelmoneim adel, lecturer

CONTACT

01004392046; Abdelmonemadel87@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,opaque 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. Prior to surgery the appropriate numbered envelopes will be opened by the nurse, the card inside will determine the patient group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: July 17, 2022
• First Posted: July 20, 2022
• Study Start: July 26, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)