Ultrasound Guided Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery

Comparison of Ultrasound Guided High Thoracic Erector Spinae Plane Block With Shoulder Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery

This study aimed to compare the efficacy of high thoracic-ESPB with shoulder block as analgesic options for arthroscopic shoulder surgery.

Primary outcome:

• 24-hour analgesic consumption.

Secondary outcomes:

• Postoperative pain evaluated by: Visual Analogue Pain Scale (VAS).
• Time to first rescue analgesia and total postoperative consumption of analgesia.
• Effect of the block on Hemodynamics.
• Adverse effects in the form of postoperative nausea and vomiting (PONV).
• Patient satisfaction.

Study Overview

• Status: Active, not recruiting
• Conditions: Analgesia
• Intervention / Treatment: Procedure: High Thoracic Erector Spinae Plane Block; Procedure: Shoulder Block

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • MenoufiaU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients within the age range ≥ 21 to ≤ 70 years old.
• Body mass index (BMI) ≤ 35kg m2.
• ASA I, II of both sex

Exclusion Criteria:

• Refusal of the patient to the study.
• Infection at the site of injection.
• Previous known allergy to any drug used in the study by history.
• Renal disease [Creatinine. >3mg/dl.].
• Hepatic disease. [ALT>50U/L, AST >50U/L].
• Un cooperative or psychological unstable patients.
• Coagulopathy or anticoagulant therapy.
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound Guided High Thoracic Erector Spinae Plane Block; High Thoracic-ESPB The patient was placed in the lateral decubitus. Subsequently, an ultrasound (US)-guided aseptic technique, with a high-frequency linear probe enveloped in a sterile sheath containing a thin film of US gel, was used to locate the transverse process of T2. After LA skin infiltration, a 22-G block was inserted in a cephalocaudal direction until the space between the fascia of the erector spinae and the transverse process of T2 was identified. After negative aspiration, hydro dissection using 2 mL of saline was performed. Eventually, 30 mL of the LA bupivacaine 0.25% and epinephrine 5 µg/ mL was injected.	Procedure: High Thoracic Erector Spinae Plane Block; High Thoracic-ESPB The patient was placed in the lateral decubitus. The transverse process of T2 was identified. After negative aspiration, hydro dissection using 2 mL of saline was performed. Eventually, 30 mL of the LA bupivacaine 0.25% and epinephrine 5 µg/ mL was injected.
Active Comparator: Ultrasound Guided Shoulder Block; Shoulder Block Suprascapular nerve block (SSNB) approach: A high-frequency linear probe was utilized across the supra-spinous fossa parallel to the spine of the scapula after skin cleaning with an antiseptic solution, if a deep block is required, a low frequency probe was required. A hyperechoic line was identified, followed by an acoustic shadow that corresponds to the floor of the supra-spinous fossa. The needle was progressed in plane from medial to lateral after local infiltration of the skin with 1% lidocaine. We directed the needle towards the lateral side of the supra-spinous fossa if the neuro-vascular bundle was not evident. After careful aspiration, 10 ml of 0.5% bupivacaine was injected under the supraspinatus muscle. Along with Axillary nerve block technique.	Procedure: Shoulder Block; Shoulder Block Suprascapular nerve block (SSNB) approach: The needle was progressed in plane from medial to lateral after local infiltration of the skin with 1% lidocaine. We directed the needle towards the lateral side of the supra-spinous fossa if the neuro-vascular bundle was not evident. After careful aspiration, 10 ml of 0.5% bupivacaine was injected under the supraspinatus muscle. Axillary nerve block technique: The nerve approach had been described in plane from cranial to caudal. After local infiltration of the skin with 1% lidocaine, the needle tip must be visualized within the fascia below the teres minor muscle and just above the PCHA. After cautious aspiration, 10 ml of 0.5% bupivacaine was injected on the posterior aspect of the humerus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour analgesic consumption.	Total consumptive dose of Morphine. Patients started acetaminophen (1 g PO) before surgery. Acetaminophen infusion continued postoperatively at a dose of 1 g/6 hours. Later, 75 mg diclofenac sodium was also given intravenously twice a day, in combination with 40 mg pantoprazole once. Rescue analgesia of 2.5 mg morphine was given intravenously if the postoperative Visual Analogue Scale score was > 3 or the patient requested additional analgesia.	24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale.	The pain control target was considered at Visual Analogue Scale score (VAS) < 4, where VAS score of 0 means no pain and VAS score of 10 means the worst pain imaginable. Postoperative pain evaluated by: Visual Analogue Pain Scale (VAS). Time to first rescue analgesia and total postoperative consumption of analgesia. Effect of the block on Hemodynamics. Adverse effects in the form of postoperative nausea and vomiting	● Every 0.5 hour for next 2 hours. ● Every 2 hours for next 6 hours. ● Every 6 hours for remaining 24 hours post-operatively.

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2023
• Primary Completion (Estimated): January 14, 2024
• Study Completion (Estimated): January 14, 2024

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: 122023ANET14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No