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Clinical Trials/NCT04483323
NCT04483323
Completed
N/A

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

Tanta University1 site in 1 country60 target enrollmentAugust 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Shoulder Arthroscopy
Sponsor
Tanta University
Enrollment
60
Locations
1
Primary Endpoint
The amount of total postoperative rescue analgesic consumption (mg)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
March 16, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Taysser Mahmoud Abdalraheem

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

Eligibility Criteria

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

Outcomes

Primary Outcomes

The amount of total postoperative rescue analgesic consumption (mg)

Time Frame: 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 Outcomes

  • Postoperative visual analogue scale(First 24 hours postoperative)

Study Sites (1)

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