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

NCT04483323 | Completed

• 1 other identifier: 33097/04/19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative visual analogue scale

  First 24 hours postoperative

Other Outcomes (1)

• The time to first request of rescue analgesia (hours)

  First 24 hours postoperative

Study Arms (2)

Group I: Intraarticular group ( IA )

ACTIVE COMPARATOR

Patients will receive 20 ml of 0.25% bupivacaine intra-articularly through the surgical port

Procedure: Intraarticular Injection

Group II: Erector Spinae Plane Block group ( ES )

EXPERIMENTAL

Patients will receive an ultrasound guided erector spinae plane block using 20 ml of 0.25% bupivacaine at the level of T2 transverse process

Procedure: Erector Spinae Plane Block

Interventions

Erector Spinae Plane Block PROCEDURE

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.

Group II: Erector Spinae Plane Block group ( ES )

Intraarticular Injection PROCEDURE

Intraarticular injection of local anesthetic through the surgical port

Group I: Intraarticular group ( IA )

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-II
• Posted for elective shoulder arthroscopy

You may not qualify if:

• Coagulopathy
• Allergy to local anesthetics
• Chronic use of narcotics
• Necessity for an intra articular drain after surgery
• Patients refusal to participate

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbiaa, 31527, Egypt

Location

MeSH Terms

Interventions

Injections, Intra-Articular

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Taysser M Abdelraheem, MD

  Lecturer at Tanta University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: August 1, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 16, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)