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

Not Applicable

Completed

• Conditions: Postoperative Analgesia; Shoulder Arthroscopy; Intraarticular Injection; Erector Spinae Plane Block
• Interventions: Procedure: Erector Spinae Plane Block; Procedure: Intraarticular Injection

• Registration Number: NCT04483323
• Lead Sponsor: Tanta University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-23
• Study Start: 2020-08-01
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-16
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-04
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II: Erector Spinae Plane Block group ( ES )	Erector Spinae Plane Block	Patients will receive an ultrasound guided erector spinae plane block using 20 ml of 0.25% bupivacaine at the level of T2 transverse process
Group I: Intraarticular group ( IA )	Intraarticular Injection	Patients will receive 20 ml of 0.25% bupivacaine intra-articularly through the surgical port

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative visual analogue scale	First 24 hours postoperative	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.

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, ElGharbiaa, Egypt