A Comparative Study Between Ultrasound Guided Shoulder Block and Pericapsular Nerve Group Bock for Shoulder Arthroscopic Surgeries: Double Blinded Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Shoulder arthroscopic surgeries are one of the most common procedures performed on a daily basis in our practice. The arthroscopic techniques offer a lesser invasive option as Open repair does not offer a significantly better 2-year result in terms of stability, and furthermore, can negatively affect the recovery of the full range of motion of the shoulder. Open techniques Shoulder procedures are performed arthroscopically nowadays with fewer complications compared with open surgery. Indications of shoulder arthroscopy are expanding and include biceps tears, labral tears, rotator muscles tears, subacromial impingements chondral injuries, loose bodies, early degenerative changes, adhesive capsulitis, shoulder instability and acromioclavicular osteoarthritis. There are many regional anesthetic techniques used to control perioperative pain during arthroscopic procedures. Interscalene block results in effective shoulder surgery analgesia, but it is associated with various complications such as diaphragmatic paralysis due to the high incidence of phrenic nerve block. The suprascapular nerve block combined with the axillary nerve block is non-inferior to conventional inter-scalene block except for the early recovery period with the advantage of lower incidence of dyspnea and discomfort. . In a cadaveric anatomical study that the posterosuperior quadrant and the posteroinferior quadrant of the GHJ were innervated by the suprascapular nerve and the axillary nerve respectively. While the anterosuperior quadrant portion of the joint is sensory supplied by the subscapularis superior branch and the anteroinferior by the main branch of the axillary nerve. These anatomical data the possibility of a new block targeting the GHJ sensory branches. It was suggested that deep pericapsular infiltration of local anesthetic towards the subscapularis may cover the axillary and subscapularis branches that feed the anteroinferior and superior quadrants of the GHJ. Recently, the pericapsular nerve group block of the shoulder joint as described in a case series including two cases underwent a humeral neck fracture fixation and Bankart arthroscopic repair with promising anesthesia and analgesia in selected shoulder surgeries.

Detailed Description
-----------------
anesthetics Bleeding disorders receiving antiplatelet or anticoagulant drugs local infection at site of local injection Intra articular infections Sample size and methodology: WE will enroll 42 patient undergoing elective shoulder arthroscopy. They will be randomized and allocated into two groups; Group A and group B. Group A will receive ultrasound guided PENG block and group B will receive shoulder block Sample size justification Sample size was calculated using Power Analysis and Sample Size software program (PASS) version 11.0.4 for windows (2011) with time to first analgesic request as the primary outcome. Using the results published by Pani et al 2019 (8) with the mean time to first analgesic request in shoulder block group was (5.9 ± 1.2 hours) Using a two-sided two-sample unequal-variance t-test, sample size of 42 patients is needed to achieve 95% power to detect 20 % difference in time to first analgesic request. Using a two-sided hypothesis test with a significance level of 0.05. Anticipated Results The application of pericapsular nerve group block in patients undergoing elective shoulder arthroscopic surgeries may improve management of their perioperative pain. Randomization: The study subjects will be randomized by using block randomization using sealed concealed envelopes into two groups. Data collection: The patients will be observed or 24 hours postoperatively by a blinded investigator for the given block. All patients will receive one gram acetaminophen intravenously every 8 hours as apart o multimodal analgesia protocol. Primary outcome will be the duration of analgesia (time to first rescue analgesia after administration of the block). Postoperative pain will be assessed using 100 mm vertical visual analogue score (VAS). The pain score will be recorded at 0, 1, 4, 8, 12, and 24 hours at rest (VASr) and movement (VASm). Morphine will be given intravenously if VASr, VASm or both exceeds 30mm in one milligram allequate with 5 minutes intervals till VAS be less than 30 mm or exceeding safety dose of 30 mg in 4 hours. Secondary outcomes: Total fentanyl consumptions as a rescue analgesia intaoperatively. Total morphine consumption in 24 hours postoperatively. Intraoperative hemodynamics mean arterial pressure and mean heart rate. length of stay in hospital Ability to perform physical rehabilitation program in the first 24 hours postoperatively. postoperative sedation score using Ramsey score patient satisfaction will be assessed by numerical score (1= very dissatisfied, 2= dissatisfied, 3=neither satisfied or dissatisfied, 4= satisfied, 5=very satisfied) postoperative nausea and vomiting (PONV) will be assessed using four points numerical score (0=no PONV, 1= mild nausea , 2= severe nausea or vomiting once, 3= vomiting more than once) End point: The observation of patients will be finished 24 hours posoperatively. Results: It will be recorded and analyzed statistically.

Official Title
-----------------
A Comparative Study Between Ultrasound-guided Shoulder Block and Pericapsular Nerve Group Bock for Shoulder Arthroscopic Surgeries.

Conditions
-----------------
Efficacy of PENG Block Managing Perioperative Pain With Shoulder Arthroscopy Surgeries, Efficacy of Shoulder Block in Managing Perioperative Pain With Shoulder Arthroscopy Surgeries

Intervention / Treatment
-----------------
* Procedure: Shoulder PENG block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I - II Age between 18 - 60 unilateral elective shoulder arthroscopic surgery Exclusion Criteria: Patient refusal Altered mental status or un-cooperative patients Hypersensitivity to local anesthetics Bleeding disorders receiving antiplatelet or anticoagulant drugs local infection at the site of local injection Intra articular infections

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Shoulder PENG block group<br>Ultrasound-guided peri-capsular nerve block of the shoulder with 20ml of 0.25% bupivacaine between the supraspinatus muscle and deltoid muscle. | Procedure: Shoulder PENG block<br>* Ultrasound guided insertion of a needle between subscapularis tendon and deltoid with injection of 10 mi 0.25% bupivacaine after confirming right plane of injection<br>* Other names: Shoulder Block;|
| Active Comparator: Shoulder block<br>ultrasound guided axillary nerve block and suprascapular nerve block posterior approach with 10 ml 0.25% bupivacaine (total 20ml) | Procedure: Shoulder PENG block<br>* Ultrasound guided insertion of a needle between subscapularis tendon and deltoid with injection of 10 mi 0.25% bupivacaine after confirming right plane of injection<br>* Other names: Shoulder Block;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of analgesia (time to first rescue analgesia) minutes | Postoperative pain will be assessed using 100 millimeter vertical visual analog score (VAS) where (1-3) no pain, >3- 6) mild pain, and (>6 severe pain). The pain score will be recorded at 0, 1, 4, 8, 12, and 24 hours at rest (VASr) and movement (VASm). Morphine will be given intravenously if VASr, VASm, or both exceed 30mm in one milligram adequate with 5 minutes intervals till VAS be less than 30 mm or exceeds the safety dose of 30 mg in 4 hours. | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption milligrams | Total morphine consumption in 24 hours postoperatively. | 24 hours after surgery | 
| Total fentanyl consumptions microgram | Total fentanyl consumptions as a rescue analgesia intaoperatively | Intraoperative period | 
| intraoperative hemodynamics | Mean arterial blood pressure millimeter mercury , mean heart rate beat per minute | Intraoperative period | 
| length of stay in hospital hours | length of stay in hospital after surgery by hours | 24 hours postoperative | 
| postoperative sedation | Ramsey sedation Score | Immediate postoperative period | 
| patient satisfaction | numerical score (1= very dissatisfied, 2= dissatisfied, 3=neither satisfied or dissatisfied, 4= satisfied, 5=very satisfied) | 24 hours postoperative | 
| postoperative nausea and vomiting (PONV) | four points numerical score (0=no PONV, 1= mild nausea , 2= severe nausea or vomiting once, 3= vomiting more than once) | 24 hours postoperative |