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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05386095
Other study ID # MS-621-2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 29, 2022
Est. completion date November 10, 2022

Study information

Verified date March 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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Locations

Country Name City State
Egypt Kasr Alainy Hospitals Giza Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pain score at 0,1,2, 4, 8 and 12 hours postoperative. FLACC is a behavioral pain assessment scale used for nonverbal or preverbal patients who are unable to self-report their level of pain. Pain is assessed through observation of 5 categories including face, legs, activity, cry, and consolability. 12 hours
Secondary cumulative 24 hours opioid consumption amount of pethidine given to the patient post operative(mg/24 hour) 24 hours
Secondary intraoperative heart rate Heart rate of the patient intraoperatively (beat/minute) every 15 minutes intraoperative till end of surgery (up to 1 hours)
Secondary intraoperative mean blood pressure mean arterial blood pressure of the patient intraoperatively (mmHg) every 15 minutes intraoperatively till end of surgery (up to 1 hour)
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