Ultrasound Guided Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery

NCT ID: NCT06202430

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-13
• Study Completion Date: 2024-01-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

High Thoracic Erector Spinae Plane Block

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Shoulder Block

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Nevine Mostafa Soliman

Lecturer of Anesthesiology, ICU and Pain Management.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

MenoufiaU

Cairo, , Egypt

Countries

Egypt

Other Identifiers

122023ANET14

Identifier Type: -

Identifier Source: org_study_id