Erector Spinae Plane Block Versus Intraarticular Injection for Postoperative Analgesia in Shoulder Arthroscopy
Primary Purpose
Shoulder Arthroscopy, Postoperative Analgesia, Erector Spinae Plane Block
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Intraarticular Injection
Sponsored by
About this trial
This is an interventional other trial for Shoulder Arthroscopy
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
Sites / Locations
- Tanta University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group I: Intraarticular group ( IA )
Group II: Erector Spinae Plane Block group ( ES )
Arm Description
Patients will receive 20 ml of 0.25% bupivacaine intra-articularly through the surgical port
Patients will receive an ultrasound guided erector spinae plane block using 20 ml of 0.25% bupivacaine at the level of T2 transverse process
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04483323
Brief Title
Erector Spinae Plane Block Versus Intraarticular Injection for Postoperative Analgesia in Shoulder Arthroscopy
Official Title
Erector Spinae Plane Block Versus Intraarticular Injection of Local Anesthetic for Postoperative Analgesia in Patients Undergoing Shoulder Arthroscopy; A Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
March 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Arthroscopy, Postoperative Analgesia, Erector Spinae Plane Block, Intraarticular Injection
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I: Intraarticular group ( IA )
Arm Type
Active Comparator
Arm Description
Patients will receive 20 ml of 0.25% bupivacaine intra-articularly through the surgical port
Arm Title
Group II: Erector Spinae Plane Block group ( ES )
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intraarticular Injection
Intervention Description
Intraarticular injection of local anesthetic through the surgical port
Primary Outcome Measure Information:
Title
The amount of total postoperative rescue analgesic consumption (mg)
Description
Rescue analgesia in the form of diclofenac sodium 75mg intramuscularly (IM) will be given if the visual analogue scale ≥ 40
Time Frame
First 24 hours postoperative
Secondary Outcome Measure Information:
Title
Postoperative visual analogue scale
Description
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.
Time Frame
First 24 hours postoperative
Other Pre-specified Outcome Measures:
Title
The time to first request of rescue analgesia (hours)
Description
Time till the first need of rescue analgesia in the form of diclofenac sodium 75mg postoperative
Time Frame
First 24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taysser M Abdelraheem, MD
Organizational Affiliation
Lecturer at Tanta University Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
ElGharbiaa
ZIP/Postal Code
31527
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Erector Spinae Plane Block Versus Intraarticular Injection for Postoperative Analgesia in Shoulder Arthroscopy
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