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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04727515
• Other study ID #: FMASU M D 186/2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 2021

Study information

• Verified date: January 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

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.

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.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting requiring treatment	First 24 hours postoperatively
Secondary	Visual analogue scale [VAS]	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
Secondary	Pittsburgh Sleep Quality Index	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