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

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

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 Overview

• Status: Completed
• Conditions: Proximal Humerus Fractures
• Intervention / Treatment: Procedure: Patients will receive Interscalene block.; Procedure: Patients will receive Supra scapular nerve block and Axillary nerve block.

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt
      • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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.
Active Comparator: Patients will receive Interscalene block.; ultrasound guided interscalene brachial plexus block will be provided to the patient	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2024
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: FAMSU R10/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No