Ultrasound Guided Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery

NCT06202430 | Unknown

• 1 other identifier: 122023ANET14
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual Analogue Scale.

  ● Every 0.5 hour for next 2 hours. ● Every 2 hours for next 6 hours. ● Every 6 hours for remaining 24 hours post-operatively.

Study Arms (2)

Ultrasound Guided High Thoracic Erector Spinae Plane Block

ACTIVE COMPARATOR

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

Ultrasound Guided Shoulder Block

ACTIVE COMPARATOR

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

Interventions

High Thoracic Erector Spinae Plane Block PROCEDURE

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.

Ultrasound Guided High Thoracic Erector Spinae Plane Block

Shoulder Block PROCEDURE

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.

Ultrasound Guided Shoulder Block

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

MenoufiaU

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, ICU and Pain Management.

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 11, 2024
• Study Start: August 13, 2023
• Primary Completion: January 14, 2024
• Study Completion: January 14, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

EG (1)