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

T

Tanta University

Status

Completed

Conditions

Postoperative Analgesia
Intraarticular Injection
Shoulder Arthroscopy
Erector Spinae Plane Block

Treatments

Procedure: Erector Spinae Plane Block
Procedure: Intraarticular Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04483323
33097/04/19

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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