Ultrasound Guided Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery

Not Applicable

Active, not recruiting

• Conditions: Analgesia
• Interventions: Procedure: High Thoracic Erector Spinae Plane Block; Procedure: Shoulder Block

• Registration Number: NCT06202430
• Lead Sponsor: Menoufia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-13
• Study First Submitted: 2023-12-27
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11
• Primary Completion: 2024-01-14
• Study Completion: 2024-01-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Guided High Thoracic Erector Spinae Plane Block	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.
Ultrasound Guided Shoulder Block	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.

Primary Outcome Measures

Name	Time	Method
24-hour analgesic consumption.	24 hours.	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.

Secondary Outcome Measures

Name	Time	Method
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.	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

Trial Locations

Locations (1)

MenoufiaU; 🇪🇬 Cairo, Egypt