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

Postoperative Analgesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483323
• Other study ID #: 33097/04/19
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: March 16, 2021

Study information

• Verified date: April 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 16, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Intraarticular Injection
• Postoperative Analgesia
• Shoulder Arthroscopy

Intervention

Procedure:
• Erector Spinae Plane Block
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.
• Intraarticular Injection
Intraarticular injection of local anesthetic through the surgical port

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	ElGharbiaa

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The time to first request of rescue analgesia (hours)	Time till the first need of rescue analgesia in the form of diclofenac sodium 75mg postoperative	First 24 hours postoperative
Primary	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	First 24 hours postoperative
Secondary	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.	First 24 hours postoperative