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

Proximal Humerus Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253442
• Other study ID #: FAMSU R10/2024
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2024
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Ain Shams University
• Contact: Riham Fa Galal, MD
• Phone: 01022739211
• Email: rihamfathygalal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humerus Fractures

Intervention

Procedure:
• Patients will receive Supra scapular nerve block and Axillary nerve block.
Suprascapular nerve block will be done by posterior approach with the patient sitting up and leaning forward. The linear ultrasound probe will identify the suprascapular nerve, after that we will inject aliquots of Sunnypivacaine 0.5% 15 ml after negative aspiration of blood. For the axillary nerve block, the ultrasound transducer will be placed in a sagittal plane over the humeral head on the posterior aspect of the arm to identify the deltoid muscle, neck of the humerus, the teres minor muscle, the circumflex humeral artery, and the triceps muscle. After the neurovascular quadrangular space identification and observing the deltoid muscle response to stimulation, a local anesthetic (10 ml 0.25% Sunnypivacaine) will be injected with the in-plain technique.
• Patients will receive Interscalene block.
Interscalene nerve block will be done ultrasound-guided using a linear array ultrasound transducer. While the patient is in the supine position, the head will be rotated to the contralateral side of the block. Ultrasound scanning will be performed in the transverse plane with long axis of the probe parallel to clavicle to visualize the brachial plexus between the anterior and middle scalene muscles. A 5-cm 22-gauge insulated needle will then be inserted in line with the probe in a lateral-to-medial needle orientation. Local anesthetic solution will then be injected in 15-ml aliquots Sunnypivacaine 0.5% after negative aspiration for blood to achieve spread posterior to or between the C5 and C6 nerve roots.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual visual analog pain scores (VAS) at 0, 6, 12 and 24 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).	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
Primary	The presence of moderate-to-severe pain, defined as visual analog pain scores (VAS) 4 or greater during the first 24 h postoperative.	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
Primary	Time to first reported pain and first analgesic request during post-anesthesia care unit stay (in minutes).	Time to first reported pain and first analgesic request during post-anesthesia care unit stay (in minutes).	24 HOURS
Primary	Analgesic consumption during surgery, in post-anesthesia care unit, and during the first 24 h post-surgery.	Analgesic consumption during surgery, in post-anesthesia care unit, and during the first 24 h post-surgery.	24 hours