NCT05578885

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

October 11, 2022

Last Update Submit

January 13, 2024

Conditions

Keywords

DexamethasoneIntravenous regional anesthesiaFentanylLidocaine

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 COMPARATOR

will receive Lidocaine

Procedure: Bier block

Group B

ACTIVE COMPARATOR

will receive Lidocaine Plus fentanyl

Procedure: Bier block

Group C

ACTIVE COMPARATOR

will receive lidocaine Plus dexamethasone

Procedure: Bier block

Interventions

Bier blockPROCEDURE

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

Group AGroup BGroup C

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Study Officials

  • Michael Shehata, Resident

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Eman Ismail, Professor

    Assiut University

    STUDY DIRECTOR
  • Alaa Atia, Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Michael Shehata, Resident

CONTACT

Eman Ismail, Professor

CONTACT

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

Locations