Ultrasound Guided Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06202430
• Other study ID #: 122023ANET14
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 13, 2023
• Est. completion date: January 14, 2024

Study information

• Verified date: January 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: January 14, 2024
• Est. primary completion date: January 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	MenoufiaU	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.