Duration of Analgesia in Bier Block for Patients Undergoing Hand Surgery

NCT ID: NCT05578885

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-07-01

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.

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

Conditions

Regional Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

will receive Lidocaine

Group Type: PLACEBO_COMPARATOR

Bier block

Intervention Type: PROCEDURE

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 B

will receive Lidocaine Plus fentanyl

Group Type: ACTIVE_COMPARATOR

Bier block

Intervention Type: PROCEDURE

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 C

will receive lidocaine Plus dexamethasone

Group Type: ACTIVE_COMPARATOR

Bier block

Intervention Type: PROCEDURE

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

Interventions

Bier 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ASA Grade 1 & 2

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michael Bishay Shehata Keroles

OTHER

Sponsor Role: lead

Responsible Party

Michael Bishay Shehata Keroles

Resident doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Shehata, Resident

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Eman Ismail, Professor

Role: STUDY_DIRECTOR

Assiut University

Alaa Atia, Professor

Role: STUDY_DIRECTOR

Assiut University

Locations

Faculty of medicine Assiut university

Asyut, , Egypt

Countries

Egypt

Central Contacts

Michael Shehata, Resident

Role: CONTACT

michaelbeshay260@gmail.com

+201022609690

Eman Ismail, Professor

Role: CONTACT

emanismail@aun.edu.eg

+201060223750

Other Identifiers

IVRA

Identifier Type: -

Identifier Source: org_study_id