Pain Alleviation of Forearm Fractures
Perioperative Pain Alleviation of Forearm Fractures Using a Combination of Hematoma Block and Intravenous Regional Anesthesia by Ketamine and Lidocaine
1 other identifier
interventional
66
1 country
1
Brief Summary
fractures of upper limb induce much pain . A lot of modalities are available to alleviate pain. fracture hematoma block, and intravenous regional anesthesia seem to be cost effective and attractive options
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2017
CompletedFirst Posted
Study publicly available on registry
December 19, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 28, 2019
February 1, 2019
9 months
December 12, 2017
February 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain assessment
pain will be assessed by numerical rating scale
24 hours
Secondary Outcomes (1)
analgesia requirement
24 hours
Study Arms (3)
Ketamine in hematoma block
ACTIVE COMPARATORKetamine used in hematoma block
ketamine intravenous anesthesia
ACTIVE COMPARATORketamine used in local intravenous anesthesia
lidocaine intravenous anesthesia
ACTIVE COMPARATOR2.5 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml.
Interventions
ketamine will be used with lidocaine in local intravenous anesthesia
2.5 mg/kg of lidocaine 2% in intravenous regional anesthesia
Eligibility Criteria
You may qualify if:
- All patients aged more than 18 years old.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Patients scheduled for closed fracture of distal upper extremity within 7 days, requiring open or closed reduction and internal fixation.
- Patients scheduled for procedure lasting less than 90 minutes.
You may not qualify if:
- Patients having cardiovascular co-morbidities.
- Compound or contaminated fracture.
- Peripheral vascular disease, sickle cell disease or coagulation disorders.
- Allergy to the local anesthetics or to the drugs used in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Assiut University
Asyut, 71111, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
December 12, 2017
First Posted
December 19, 2017
Study Start
February 1, 2018
Primary Completion
November 1, 2018
Study Completion
December 1, 2018
Last Updated
February 28, 2019
Record last verified: 2019-02