Axillary Brachial Plexus Block Using 0.25% Bupivacaine Versus Using 0.19%Bupivacaine in Pediatrics

NCT05386095 | Completed

• 1 other identifier: MS-621-2021
• 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 and inadequate intraoperative pain assessment and management .Axillary brachial plexus block provides motor and sensory block with the distribution of the median, radial, ulnar and musculocutaneous branches so can be conducted with upper limb orthopedic surgery in hand, rest and elbow surgery distal to the cubital fossa . In this study the investigators will investigate (0.19%) and (0.25%) bupivacaine for postoperative motor power recovery and post-operative analgesic efficacy in ultrasound guided axillary brachial plexus block among pediatric patient undergoing below elbow orthopedic surgery.

Conditions

Acute Postoperative Pain; Motor Activity

Keywords

postoperative pain; axillary brachial plexus block; below elbow orthopedic surgeries; Bupivacaine; motor sparing block

Outcome Measures

Primary Outcomes (1)

• Motor power using modified bromage scale on admission to the PACU (post anesthesia care unit)

  Modified Bromage scale is a scale designed to assess degree of motor power as shown; Grade Definition 4 Full muscle strength in relevant muscle groups 3 Reduced strength, but able to move against resistance 2 Ability to move against gravity, but not against resistance 1 Discrete movements (trembling) of muscle groups 0 Lack of movement

  on admission to the PACU (10 minutes after extubation)

Secondary Outcomes (4)

• Pain score at 0,1,2, 4, 8 and 12 hours postoperative.

  12 hours

• cumulative 24 hours opioid consumption

  24 hours

• intraoperative heart rate

  every 15 minutes intraoperative till end of surgery (up to 1 hours)

• intraoperative mean blood pressure

  every 15 minutes intraoperatively till end of surgery (up to 1 hour)

Study Arms (2)

0.25%Bupivacaine group

ACTIVE COMPARATOR

Axillary brachial plexus block will be done with patient in supine position under general anesthesia . A total volume of (0.5ml/kg) 0.25% bupivacaine + 1 µg/kg dexmedetomidine.this volume will be divided equally among the median,ulnar,radial and the musculocutaneous nerve. The surgical procedure will be start after 15-20 min. At the end of surgery, residual neuromuscular block will be antagonized with IV neostigmine 0.05 mg/kg and atropine 0.02mg/kg. All patients will receive 15mg/kg paracetamol IV. At recovery room motor power will be assisted using Modified Bromage scale , then each 30 min till full recover of motor power. post operative pain assessment will be done using (FLACC score) for Pain assessment.For patients with pain score more than 4\\10 ,Pethidine I.V will be given as rescue analgesic (1 mg/kg) when needed and total rescue analgesia will be recorded.

Procedure: 0.25%Bupivacaine Axillary brachial plexus block

0.19%Bupivacaine group

EXPERIMENTAL

Axillary brachial plexus block will be performed with the patient in supine position under general anesthesia . A total volume of (0.5ml/kg) 0.19% bupivacaine + 1 µg/kg dexmedetomidine will be divided equally among the median,ulnar,radial and the musculocutaneous nerve. The surgical procedure will be start after 15-20 min.At the end of surgery, residual neuromuscular block will be antagonized with IV neostigmine 0.05 mg/kg and atropine 0.02mg/kg. All patients will receive 15mg/kg paracetamol IV. At recovery room motor power will be assessed using Modified Bromage scale , then each 30 min till full recover of motor power. post operative pain assessment will be done using (FLACC score) for Pain assessment,For patients with pain score more than 4\\10 ,Pethidine I.V will be given as rescue analgesic (1 mg/kg) when needed and total rescue analgesia will be recorded..

Procedure: 0.19% Bupivacaine Axillary brachial plexus block

Interventions

0.25%Bupivacaine Axillary brachial plexus block PROCEDURE

Axillary brachial plexus block will be induced with patient in supine position under GA with the linear probe ultrasound , the operating arm will be abducted by 70 , externally rotated, and the elbow will be flexed to \~90. Within the axillary crease the probe will be placed in sagittal position bounded by the pectoralis major antero-medially and the latissimus dorsi and teres major posteromedial. The median nerve lies between 9 and 12 o'clock position above the axillary artery and below the biceps muscle; (ii) the ulnar nerve located superficially between the axillary vein and artery (iii) the radial nerve lies above the conjoint tendon of the teres major and latissimus dorsi (iiii) The musculocutaneous nerve lies between biceps and coracobrachialis muscle .The block will be applied by 22 gag needles at cephalic side of the probe. A total volume of (0.5ml/kg) of 0.25% Bupivacaine plus 1 µg/kg dexmedetomidine will be used.this volume will be divided equally among the four nerves.

0.25%Bupivacaine group

0.19% Bupivacaine Axillary brachial plexus block PROCEDURE

Axillary brachial plexus block will be induced with patient in supine position under GA with linear probe ultrasound , the operating arm will be abducted by 70 , externally rotated, and the elbow will be flexed to \~90. Within the axillary crease the probe will be placed in sagittal position bounded by the pectoralis major antero-medially and the latissimus dorsi and teres major posteromedial. The median nerve lies between 9 and 12 o'clock position above the axillary artery and below the biceps muscle; (ii) the ulnar nerve located superficially between the axillary vein and artery (iii) the radial nerve lies above the conjoint tendon of the teres major and latissimus dorsi (iiii) The musculocutaneous nerve lies between biceps and coracobrachialis muscle.The block will be applied by 22 gag needles at cephalic side of the probe. A total volume of (0.5ml/kg) of 0.19% Bupivacaine plus 1 µg/kg dexmedetomidine will be used.this volume will be divided equally among the four nerves.

0.19%Bupivacaine group

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American society of Anesthesiologists (ASA )class I-II
• Duration of surgery less than 1 hour.

You may not qualify if:

• Parent refusal.
• Prolonged procedure exceeding 1 hour.
• Patients with apparent infection at site of needle insertion.
• Patients with any coagulation disorder(Platelets ≤ 50,000 and/or international normalized ratio INR\> 1.5)
• Patients with known neuropathy or brachial plexus injury.
• Patients with any cardiac, hepatic, renal failure.
• Patient with known sensitivity to local anesthetic drugs.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy Hospitals

Giza, Cairo Governorate, 11562, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Motor Activity

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Study Officials

• Maha G Hanna, professor

  Anesthesia department , cairo university

  PRINCIPAL INVESTIGATOR

• Dalia S Abdelkader, assprofessor

  Anesthesia department , Cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 23, 2022
• Study Start: May 29, 2022
• Primary Completion: October 22, 2022
• Study Completion: November 10, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)