General Anesthesia, Versus Axillary Block for Ambulatory Hand Surgery: Randomized Prospective Study

NCT ID: NCT04727515

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-05-31

Brief Summary

This study aims to compare between general anesthesia and axillary nerve block for ambulatory hand surgery regarding postoperative sleep pattern and efficacy.

Conditions

Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

General anesthesia

Patients will receive general anesthesia

Group Type: EXPERIMENTAL

fentanyl 2µg/kg intravenously and maintained with isoflurane

Intervention Type: DRUG

Anesthesia will be induced using titration of intravenous propofol till loss of verbal contact and fentanyl 2µg/kg intravenously and maintained with isoflurane (end tidal up to 1.5%), oxygen in air 50:50 via a laryngeal mask.

Axillary Block

Patients will receive axillary nerve block

Group Type: EXPERIMENTAL

Axillary nerve Block

Intervention Type: PROCEDURE

Axillary block will be performed using ultrasound technique. Patients will receive an axillary block under ultrasound guidance using a linear 5-12 MHz probe.

Interventions

fentanyl 2µg/kg intravenously and maintained with isoflurane

Anesthesia will be induced using titration of intravenous propofol till loss of verbal contact and fentanyl 2µg/kg intravenously and maintained with isoflurane (end tidal up to 1.5%), oxygen in air 50:50 via a laryngeal mask.

Intervention Type: DRUG

Axillary nerve Block

Axillary block will be performed using ultrasound technique. Patients will receive an axillary block under ultrasound guidance using a linear 5-12 MHz probe.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Physical Status: ASA I and II Patients after taking written and informed consent
• Body mass index less than 30

Exclusion Criteria

• Refusal of procedure or participation in the study by patients.
• Physical status: ASA III or above
• Subjects presenting with allergy to local anesthetics, alcohol or drug abuse.
• Inability to cooperate mentally retarded patients.
• Bleeding disorders.
• Patients with preoperative obstructive sleep apnea (OSA) or any sleep disturbance.
• Patients with body mass index more than 30.
• Polytrauma patients or emergency operation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mennatullah Mohammed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU M D 186/2019

Identifier Type: -

Identifier Source: org_study_id