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

April 4, 2021 updated by: Taysser Mahmoud Abdalraheem, Tanta University

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • ElGharbiaa
      • Tanta, ElGharbiaa, Egypt, 31527
        • Tanta University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
First 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative visual analogue scale
Time Frame: 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.
First 24 hours postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time to first request of rescue analgesia (hours)
Time Frame: First 24 hours postoperative
Time till the first need of rescue analgesia in the form of diclofenac sodium 75mg postoperative
First 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Taysser M Abdelraheem, MD, Lecturer at Tanta University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ACTUAL)

March 15, 2021

Study Completion (ACTUAL)

March 16, 2021

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (ACTUAL)

July 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 4, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 33097/04/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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