NCT04727515

Brief Summary

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

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

January 25, 2021

Last Update Submit

January 26, 2021

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

  • Incidence of Postoperative nausea and vomiting

    Incidence of postoperative nausea and vomiting requiring treatment

    First 24 hours postoperatively

Secondary Outcomes (2)

  • Visual analogue scale [VAS]

    First 24 hours postoperatively

  • Pittsburgh Sleep Quality Index

    First 24 hours postoperatively

Study Arms (2)

General anesthesia

EXPERIMENTAL

Patients will receive general anesthesia

Drug: fentanyl 2µg/kg intravenously and maintained with isoflurane

Axillary Block

EXPERIMENTAL

Patients will receive axillary nerve block

Procedure: Axillary nerve Block

Interventions

fentanyl 2µg/kg intravenously and maintained with isofluraneDRUG

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.

General anesthesia
Axillary nerve BlockPROCEDURE

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

Axillary Block

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

FentanylIsoflurane

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMethyl EthersEthersOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2021

First Posted

January 27, 2021

Study Start

January 1, 2021

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

EG(1)