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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04446403
Other study ID # S-10-2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 25, 2020
Est. completion date September 30, 2020

Study information

Verified date June 2020
Source Cairo University
Contact Ahmed Zaghloul
Phone 002-01001839591
Email a_zaghloul2000@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Shoulder arthroscopy is associated with severe postoperative pain. Traditionally, the interscalene approach to the brachial plexus has been employed to manage postoperative pain following shoulder surgery.To provide more complete shoulder joint analgesia, suprascabular nerve block (SSNB) was combined with block of the circumflex nerve which comes from the posterior cord of the brachial plexus that usually gives also upper subscapular, thoracodorsal, lower subscapular and radial nerves.


Description:

Aim of the work is to compare postoperative analgesic effect of ultrasound guided combined suprascapular and circumflex nerve blocks versus suprascapular nerve and posterior cord blocks at infraclavicular level .

Thirty four patients aged from 18-70 years old, with ASA physical status I-II-III and scheduled for shoulder surgeries will be included in the study. Patients will be randomly allocated using computer-generated table into one of two groups:

- Group circumflex → will undergo ultrasound guided SSN+circumflex.

- Group posterior cord → will undergo ultrasound guided SSN+posterior cord.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 30, 2020
Est. primary completion date September 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- ASA I-II.-III

- Undergoing shoulder arthroscopy.

Exclusion Criteria:

- Patient refusal

- Known allergy to local anesthetics

- Bleeding disorders

- Inability to provide informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Suprascapular Nerve Block
The patient will be put in sitting down position with upper limbs pending beside the body then a high-frequency linear ultrasound probe will be positioned transversely above the spine of the scapula. The suprascapular nerve often appears as hypereccoic structure at the suprascapular notch. A 20-gauge spinal needle will be advanced in-plane from medial to lateral 10mL of bupivacaine 0.25% into the suprascapular notch deep to the superior transverse scapular ligament (STSL) and adjacent to the suprascapular artery (SSA) .
Axillary Nerve Block
Patient will be put in sitting position, with the shoulder in full adduction. linear transducer (8-14 MHz) will be positioned in the short axis orientation at the neck of humerous to identify the axillary artery about 1 to 3 cm from the skin surface.The artery is the most reliable landmark, then a 21-gauge 90 mm needle will be advanced in-plane and 10 mL of bupivacaine 0.25% will be injected adjacent to the artery.
posterior cord block
Patient will be put in supine position with head turned away from side that will be blocked with the arm abducted 90 and flexed at the elbow then linear transducer (8-14 MHz) will be positioned in short-axis just medial to coracoid process.Once the artery will be identified, an attempt will be made to identify the hyperechoic cords of the brachial plexus and their corresponding positions relative to the artery, although these may not always be identifiable. The needle will be inserted in plane from the cephalad end of the probe. 10 mL bupivacaine 0.25% will be injected at the posterior cord.
General anesthesia
General anaesthesia will be induced after giving nerve block in a standardized way with propofol 1.5-2.5mg/kg, fentanyl 2-3 µ/kg and atracurium 0.5mg/kg. maintenance of anaesthesia with isoflurane and atracurium 0.1mg/kg/20min.

Locations

Country Name City State
Egypt Anesthesia Department Cairo

Sponsors (2)

Lead Sponsor Collaborator
Bassant M. Abdelhamid Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Axelsson K, Gupta A, Johanzon E, Berg E, Ekbäck G, Rawal N, Enström P, Nordensson U. Intraarticular administration of ketorolac, morphine, and ropivacaine combined with intraarticular patient-controlled regional analgesia for pain relief after shoulder surgery: a randomized, double-blind study. Anesth Analg. 2008 Jan;106(1):328-33, table of contents. doi: 10.1213/01.ane.0000297297.79822.00. — View Citation

Lyons C, Herring AA. Ultrasound-guided axillary nerve block for ED incision and drainage of deltoid abscess. Am J Emerg Med. 2017 Jul;35(7):1032.e3-1032.e7. doi: 10.1016/j.ajem.2017.01.064. Epub 2017 Feb 1. — View Citation

Price DJ. The shoulder block: a new alternative to interscalene brachial plexus blockade for the control of postoperative shoulder pain. Anaesth Intensive Care. 2007 Aug;35(4):575-81. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time of the first postoperative analgesic request 12 hours postoperative
Secondary Visual analogue score visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain) and verbal pain scale (VPS )ranging from 0 to 3 (0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain). 12 hours postoperative
Secondary Total morphine consumption 12 hours postoperative
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