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Not yet recruitingNCT05578885Updated Jan 17, 2024

Duration of Analgesia in Bier Block for Patients Undergoing Hand Surgery

An interventional study of Bier block in Regional Anesthesia, sponsored by Michael Bishay Shehata Keroles. Not yet recruiting at 1 site in Egypt. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-17.

Sponsored by Michael Bishay Shehata Keroles · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

IVRA offers a favorable risk-benefit ratio, cost-effectiveness, sufficient muscle relaxation and a fast on- and offset. New upcoming methods for monitoring, specialized personnel and improved emergency equipment made IVRA even safer. Moreover, IVRA may be applied to treat complex regional pain syndromes. Prilocaine and lidocaine are considered as first-choice local anesthetics for IVRA. Also, various adjuvant drugs have been tested to augment the effect of IVRA, and to reduce post-deflation tourniquet pain. Since major adverse events are rare in IVRA, it is regarded as a very safe technique. Nevertheless, systemic neuro- and cardiotoxic side effects may be linked to an uncontrolled systemic flush-in of local anesthetics and must be avoided.

Dexamethasone decreases postoperative pain and prolongs the duration of local anaesthetic peripheral nerve blocks in studies including a limited number of patients .

Fentanyl is a powerful synthetic opioid that is similar to morphine but is 50 to 100 times more potent.fentanyl acts on opioid receptors. These receptors are G-protein-coupled receptors, which contain seven transmembrane portions, intracellular loops, extracellular loops, intracellular C-terminus, and extracellular N-terminus. The extracellular N-terminus is important in differentiating different types of binding substrates. When fentanyl binds, downstream signaling leads to the inhibitory effects, such as decreased cAMP production, decreased calcium ion influx, and increased potassium efflux. This inhibits the ascending pathways in the central nervous system to increase pain threshold by changing the perception of pain; this is mediated by decreasing propagation of nociceptive signals, resulting in analgesic effects

02

Conditions studied

  • Regional Anesthesia

Keywords

  • Dexamethasone
  • Intravenous regional anesthesia
  • Fentanyl
  • Lidocaine
03

In context

Lead sponsor

This is the only study on the registry with Michael Bishay Shehata Keroles as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • ASA Grade 1 \& 2

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • Placebo comparator
    Group A

    will receive Lidocaine

    Procedure: Bier block

  • Active comparator
    Group B

    will receive Lidocaine Plus fentanyl

    Procedure: Bier block

  • Active comparator
    Group C

    will receive lidocaine Plus dexamethasone

    Procedure: Bier block

Interventions

  • ProcedureBier block

    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

06

What researchers measure

Primary outcomes

  1. Compare duration of analgesia

    Change in the time of analgesia

    Time frame: one hour After procedure

07

Study locations

1 site
  • Faculty of medicine Assiut university
    Assiut, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05578885
Lead sponsor
Michael Bishay Shehata Keroles
Responsible party
Michael Bishay Shehata Keroles (Resident doctor, Assiut University) — Sponsor-investigator
First posted
Oct 13, 2022
Start date
Feb 1, 2024 (estimated)
Primary completion
Jul 1, 2024 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Jan 17, 2024

Study contacts

Michael Shehata, Resident
Contact
michaelbeshay260@gmail.com
+201022609690
Eman Ismail, Professor
Contact
emanismail@aun.edu.eg
+201060223750
Michael Shehata, Resident
principal investigator · Assiut University
Eman Ismail, Professor
study director · Assiut University
Alaa Atia, Professor
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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