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

NCT06253442 | Completed

• 1 other identifier: FAMSU R10/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Humerus Fractures

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Patients will receive Supra scapular nerve block and Axillary nerve block.

ACTIVE COMPARATOR

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.

Patients will receive Interscalene block.

ACTIVE COMPARATOR

ultrasound guided interscalene brachial plexus block will be provided to the patient

Procedure: Patients will receive Interscalene block.

Interventions

Patients will receive Supra scapular nerve block and Axillary nerve block. PROCEDURE

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 Supra scapular nerve block and Axillary nerve block.

Patients will receive Interscalene block. PROCEDURE

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.

Patients will receive Interscalene block.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with history of any psychiatric disorder.
• BMI more than 35 kg/m2.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasia, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 12, 2024
• Study Start: February 10, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)