Duration of Analgesia in Bier Block for Patients Undergoing Hand Surgery
Dexamethasone Versus Fentanyl as an Adjuvant to Lidocaine in Bier Block for Patients Undergoing Hand Surgery
1 other identifier
interventional
75
1 country
1
Brief Summary
Intravenous regional anesthesia (Bier block) is widely used as an anesthetic technique for operations of short duration of the distal upper or lower extremities Today, IVRA is still popular in many countries being used in the emergency room, for outpatients and for high-risk patients with contraindications for general anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
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
October 11, 2022
CompletedFirst Posted
Study publicly available on registry
October 13, 2022
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedJanuary 17, 2024
January 1, 2024
5 months
October 11, 2022
January 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare duration of analgesia
Change in the time of analgesia
one hour After procedure
Study Arms (3)
Group A
PLACEBO COMPARATORwill receive Lidocaine
Group B
ACTIVE COMPARATORwill receive Lidocaine Plus fentanyl
Group C
ACTIVE COMPARATORwill receive lidocaine Plus dexamethasone
Interventions
patients in group a (n = 25) received 2% lidocaine3 mg/kg (maximum, 200 mg) for IVRA and 2 mL NaCl 0.9% IV , patients in group b (n = 25) received 2% lidocaine 3 mg/kg (maximum, 200 mg) plus 8 mg dexamethasone for IVRA and 2 mL NaCl 0.9% IV , and those in group c (n = 25) received 2% lidocaine 3 mg/kg (maximum, 200 mg) plus fentanyl IV
Eligibility Criteria
You may qualify if:
- ASA Grade 1 \& 2
You may not qualify if:
- Patient refusal ASA Grade 3 \& 4 patients SEVERLY HYPOVOLEMIC STATE History of neurological. Reynauds disease, scleroderma, sickle cell anemia, myasthenia gravis, decompensated cardiac disease, diabetes mellitus, peptic ulcer, gastritis, and those with liver or renal insufficiency were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of medicine Assiut university
Asyut, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Shehata, Resident
Assiut University
- STUDY DIRECTOR
Eman Ismail, Professor
Assiut University
- STUDY DIRECTOR
Alaa Atia, Professor
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Resident doctor
Study Record Dates
First Submitted
October 11, 2022
First Posted
October 13, 2022
Study Start
February 1, 2024
Primary Completion
July 1, 2024
Study Completion
July 1, 2024
Last Updated
January 17, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share