Clinical trial NCT06253442: Comparison Between Interscalene Block and Combined Suprascapular and Axillary Blocks for Proximal Humerus Fracture Surgeries.
Official title: A Comparative Study Between Ultrasound Guided Interscalene Block and Combined Ultrasound Guided Suprascapular and Axillary Nerve Blocks for Proximal Humerus Fracture Surgeries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proximal Humerus Fractures
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Individual visual analog pain scores (VAS) at 0, 6, 12 and 24 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
timeFrame: 24 HOURS
measure: The presence of moderate-to-severe pain, defined as visual analog pain scores (VAS) 4 or greater during the first 24 h postoperative.
timeFrame: 24 HOURS
measure: Time to first reported pain and first analgesic request during post-anesthesia care unit stay (in minutes).
timeFrame: 24 HOURS
measure: Analgesic consumption during surgery, in post-anesthesia care unit, and during the first 24 h post-surgery.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbasia
Study officials:
References: