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

January 26, 2021 updated by: Mennatullah Mohammed, Ain Shams University
This study aims to compare between general anesthesia and axillary nerve block for ambulatory hand surgery regarding postoperative sleep pattern and efficacy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain shams university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: General anesthesia
Patients will receive general anesthesia
Drug: 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.
EXPERIMENTAL: Axillary Block
Patients will receive axillary nerve block
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative nausea and vomiting
Time Frame: First 24 hours postoperatively
Incidence of postoperative nausea and vomiting requiring treatment
First 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale [VAS]
Time Frame: First 24 hours postoperatively
Visual analogue scale [VAS] will be used to measure pain score at 30 min, 1, 2, 4, 6, 8, 10, 12 and 24 h after surgery. All the study patients will be instructed about the use of the VAS scale before induction of anesthesia (VAS score 0 cm = no pain, VAS score 10 cm = worst possible pain)
First 24 hours postoperatively
Pittsburgh Sleep Quality Index
Time Frame: First 24 hours postoperatively
Pittsburgh Sleep Quality Index will be used to measure postoperative sleep disturbance. It is formed of 19 items that assess seven clinically derived domains of sleep difficulties (Sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction) over a Likert scale (0-3)
First 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ANTICIPATED)

April 1, 2021

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (ACTUAL)

January 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU M D 186/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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