NCT04446403

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

June 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 22, 2020

Last Update Submit

June 26, 2020

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Time of the first postoperative analgesic request

    12 hours postoperative

Secondary Outcomes (2)

  • Visual analogue score

    12 hours postoperative

  • Total morphine consumption

    12 hours postoperative

Study Arms (2)

circumflex

EXPERIMENTAL

patients will undergo ultrasound guided SSN+circumflex

Procedure: Suprascapular Nerve BlockProcedure: Axillary Nerve BlockProcedure: General anesthesia

posterior cord

EXPERIMENTAL

patients will undergo ultrasound guided SSN+circumflex

Procedure: Suprascapular Nerve BlockProcedure: posterior cord blockProcedure: General anesthesia

Interventions

Suprascapular Nerve BlockPROCEDURE

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) .

Also known as: SSN
circumflexposterior cord
Axillary Nerve BlockPROCEDURE

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.

circumflex
posterior cord blockPROCEDURE

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.

posterior cord
General anesthesiaPROCEDURE

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.

circumflexposterior cord

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I-II.-III
  • Undergoing shoulder arthroscopy.

You may not qualify if:

  • Patient refusal
  • Known allergy to local anesthetics
  • Bleeding disorders
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia Department

Cairo, 1772, Egypt

RECRUITING

Related Publications (3)

  • Axelsson K, Gupta A, Johanzon E, Berg E, Ekback G, Rawal N, Enstrom 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.

    PMID: 18165599BACKGROUND

  • 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. doi: 10.1177/0310057X0703500418.

    PMID: 18020078BACKGROUND

  • 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.

    PMID: 28258838BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Mohamed Abd-Elraouf Nasr

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Ahmed Zaghloul

    Cairo University

    STUDY DIRECTOR

  • Mohsen Waheb

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Zaghloul

CONTACT

002-01001839591a_zaghloul2000@yahoo.com

Mohsen Waheb

CONTACT

002-01001525602Mohsen.mwaheb@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 24, 2020

Study Start

June 25, 2020

Primary Completion

September 20, 2020

Study Completion

September 30, 2020

Last Updated

June 29, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)