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

Not Applicable

• Conditions: Anesthesia, Local
• Interventions: Drug: fentanyl 2µg/kg intravenously and maintained with isoflurane; Procedure: Axillary nerve Block

• Registration Number: NCT04727515
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01-01
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-26
• Last Update Submitted: 2021-01-26
• Study First Posted: 2021-01-27
• Last Update Posted: 2021-01-28
• Primary Completion: 2021-04
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia	fentanyl 2µg/kg intravenously and maintained with isoflurane	Patients will receive general anesthesia
Axillary Block	Axillary nerve Block	Patients will receive axillary nerve block

Primary Outcome Measures

Name	Time	Method
Incidence of Postoperative nausea and vomiting	First 24 hours postoperatively	Incidence of postoperative nausea and vomiting requiring treatment

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale [VAS]	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)
Pittsburgh Sleep Quality Index	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)

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt