Comparison Between Interscalene Block and Combined Suprascapular and Axillary Blocks for Proximal Humerus Fracture Surgeries.

Not Applicable

Recruiting

• Conditions: Proximal Humerus Fractures
• Interventions: Procedure: Patients will receive Interscalene block.; Procedure: Patients will receive Supra scapular nerve block and Axillary nerve block.

• Registration Number: NCT06253442
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-02-08
• Study Start: 2024-02-10
• Study First Posted: 2024-02-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

1. Patient refusal
2. ASA physical status III or more.
3. Patients with known allergy to any of the study drugs.
4. Infection at the site of injection.
5. Patients with history of cardiovascular disease.
6. Patients with renal disease.
7. Patients with hepatic disease.
8. Patients with neuromuscular disease.
9. Presence of any coagulopathy.
10. Chronic opioid, gabapentin or pregabalin use.
11. Patients with history of any psychiatric disorder.
12. BMI more than 35 kg/m2.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients will receive Interscalene block.	Patients will receive Interscalene block.	ultrasound guided interscalene brachial plexus block will be provided to the patient
Patients will receive Supra scapular nerve block and Axillary nerve block.	Patients will receive Supra scapular nerve block and Axillary nerve block.	ultrasound guided suprascapular nerve block combined with ultrasound guided axillary nerve block will be provided to the patient

Primary Outcome Measures

Name	Time	Method
The presence of moderate-to-severe pain, defined as visual analog pain scores (VAS) 4 or greater during the first 24 h postoperative.	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.	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).	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).	24 HOURS	Time to first reported pain and first analgesic request during post-anesthesia care unit stay (in minutes).

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Abbasia, Egypt