Erector Spinae Plane Block Versus Intraarticular Injection for Postoperative Analgesia in Shoulder Arthroscopy

Study Overview
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Brief Summary
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To improve the outcome after surgery, effective pain control is needed. The aim of the current study was to compare the efficacy of ultrasound guided erector spinae plane block versus the intra articular injection of local anesthetic for post-operative analgesia in patients undergoing shoulder arthroscopy.

Detailed Description
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Sample size calculation: Calculation of sample size was done to detect a 15% difference in the VAS score between two groups detected that at least 27 patients were needed at an α error of 0.05 and 80 % power of the study. The number will be increased to 30 patients to avoid a 10% dropped out patients. Statistical analysis Statistical analysis will be done by Statistical Package for the Social Sciences (SPSS) v25 (IBM Inc., Chicago, USA). Normality of data will be checked with Shapiro-Wilks test and histogram. Quantitative variables will be presented as mean and standard deviation (SD) and will be compared by unpaired student T test. Categorical variables will be presented as frequency and percentage (%) and will be analysed by the Chi-square test. P value < 0.05 will be considered statistically significant.

Official Title
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Erector Spinae Plane Block Versus Intraarticular Injection of Local Anesthetic for Postoperative Analgesia in Patients Undergoing Shoulder Arthroscopy; A Prospective Randomized Controlled Study

Conditions
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Shoulder Arthroscopy, Postoperative Analgesia, Erector Spinae Plane Block, Intraarticular Injection

Intervention / Treatment
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* Procedure: Erector Spinae Plane Block
* Procedure: Intraarticular Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-II Posted for elective shoulder arthroscopy Exclusion Criteria: Coagulopathy Allergy to local anesthetics Chronic use of narcotics Necessity for an intra articular drain after surgery Patients refusal to participate

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I: Intraarticular group ( IA )<br>Patients will receive 20 ml of 0.25% bupivacaine intra-articularly through the surgical port | Procedure: Intraarticular Injection<br>* Intraarticular injection of local anesthetic through the surgical port<br>|
| Experimental: Group II: Erector Spinae Plane Block group ( ES )<br>Patients will receive an ultrasound guided erector spinae plane block using 20 ml of 0.25% bupivacaine at the level of T2 transverse process | Procedure: Erector Spinae Plane Block<br>* The patient will be placed in the lateral position. Following skin disinfection, counting down from the C7 spinous process and using ultrasound guidance, the level of T2 transverse process will be identified. A 2-5 MH2 curved array transducer (sono site Edge, Bothell, Will behington) will be positioned transversely to visualize the lateral tip of T2 transverse Process. A longitudinal parasagittal orientation will be obtained over the transverse process using a 22 - gauge 8 cm block needle (visioplex, Vygon , France) will be inserted in plane to US beam in a caudal to cranial direction to place the needle tip between the posterior fascia of the erector spinae muscle and the T2 transverse process. Position of the needle tip in the ESP deep to the erector spinae muscle will be confirmed using hydrodissection with 0.5 - 1 ml of normal saline and visualization of the linear fluid spread deep to the erector spinae muscle following which 20 ml of 0.25% bupivacaine will be injected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of total postoperative rescue analgesic consumption (mg) | Rescue analgesia in the form of diclofenac sodium 75mg intramuscularly (IM) will be given if the visual analogue scale ≥ 40 | First 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative visual analogue scale | Visual analogue scale (VAS) for determination of intensity of the pain on scale from (0-100) where 0= no pain and 100=the worst pain. | First 24 hours postoperative |