Skip to main content
Clinical Trials/NCT06253442
NCT06253442
Recruiting
Not Applicable

A Comparative Study Between Ultrasound Guided Interscalene Block and Combined Ultrasound Guided Suprascapular and Axillary Nerve Blocks for Proximal Humerus Fracture Surgeries.

Ain Shams University1 site in 1 country50 target enrollmentFebruary 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Proximal Humerus Fractures
Sponsor
Ain Shams University
Enrollment
50
Locations
1
Primary Endpoint
The presence of moderate-to-severe pain, defined as visual analog pain scores (VAS) 4 or greater during the first 24 h postoperative.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

A Comparative study Between Ultrasound guided Interscalene Block and Combined Ultrasound guided suprascapular and axillary nerve blocks for proximal humerus fracture Surgeries.

The aim of this study is to investigate whether (Suprascapular nerve block) and (Axillary nerve block) are effective in providing analgesia for shoulder surgery as an (Interscalene block), while minimizing the occurrence of hemi-diaphragmatic paralysis. We hypothesized that analgesia with a (Suprascapular nerve block and Axillary nerve block) would be noninferior compared with patients receiving an interscalene block and the incidence of hemi-diaphragmatic paralysis would be significantly lower with (Suprascapular nerve block and Axillary nerve block) in proximal humerus fracture surgeries.

Detailed Description

A Comparative study Between Ultrasound guided Interscalene Block and Combined Ultrasound guided suprascapular and axillary nerve blocks for proximal humerus fracture Surgeries. The aim of this study is to investigate whether (Suprascapular nerve block) and (Axillary nerve block) are effective in providing analgesia for shoulder surgery as an (Interscalene block), while minimizing the occurrence of hemi-diaphragmatic paralysis. We hypothesized that analgesia with a (Suprascapular nerve block and Axillary nerve block) would be noninferior compared with patients receiving an interscalene block and the incidence of hemi-diaphragmatic paralysis would be significantly lower with (Suprascapular nerve block and Axillary nerve block) in proximal humerus fracture surgeries.

Registry
clinicaltrials.gov
Start Date
February 10, 2024
End Date
August 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

riham fathy galal

Lecturer

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Patients American Society of anesthesiologists' physical status (ASA) I to II.
  • Aged 18 to 65 years.
  • Both sexes.
  • Patients scheduled for proximal humerus fracture surgeries.

Exclusion Criteria

  • Patient refusal
  • ASA physical status III or more.
  • Patients with known allergy to any of the study drugs.
  • Infection at the site of injection.
  • Patients with history of cardiovascular disease.
  • Patients with renal disease.
  • Patients with hepatic disease.
  • Patients with neuromuscular disease.
  • Presence of any coagulopathy.
  • Chronic opioid, gabapentin or pregabalin use.

Outcomes

Primary Outcomes

The presence of moderate-to-severe pain, defined as visual analog pain scores (VAS) 4 or greater during the first 24 h postoperative.

Time Frame: 24 HOURS

The presence of moderate-to-severe pain, defined as visual analog pain scores (VAS) 4 or greater during the first 24 h postoperative.

Analgesic consumption during surgery, in post-anesthesia care unit, and during the first 24 h post-surgery.

Time Frame: 24 hours

Analgesic consumption during surgery, in post-anesthesia care unit, and during the first 24 h post-surgery.

Individual visual analog pain scores (VAS) at 0, 6, 12 and 24 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).

Time Frame: 24 HOURS

Individual visual analog pain scores (VAS) at 0, 6, 12 and 24 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).

Time to first reported pain and first analgesic request during post-anesthesia care unit stay (in minutes).

Time Frame: 24 HOURS

Time to first reported pain and first analgesic request during post-anesthesia care unit stay (in minutes).

Study Sites (1)

Loading locations...

Similar Trials