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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04727515
Enrollment
40
Registered
2021-01-27
Start date
2021-01-01
Completion date
2021-05-31
Last updated
2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local

Brief summary

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

Interventions

DRUGfentanyl 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.

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Postoperative nausea and vomitingFirst 24 hours postoperativelyIncidence of postoperative nausea and vomiting requiring treatment

Secondary

MeasureTime frameDescription
Visual analogue scale [VAS]First 24 hours postoperativelyVisual 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)
Pittsburgh Sleep Quality IndexFirst 24 hours postoperativelyPittsburgh 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026