NCT05791058

Brief Summary

Recently, the Combined suprascapular nerve block and axillary nerve block (SSNB+ANB) was proposed to provide anesthesia and postoperative analgesia for shoulder surgery as a safe alternative to interscalene block. These two peripheral nerves are responsible for the majority of the sensory innervation of the shoulder. PENG block has been studied extensively in hip surgeries, but its place in shoulder surgeries is not yet clear. It is a new technology reported for block of articular branches of the shoulder and well pericapsular spread around the glenohumeral joint Therefore, achieving pain relief while avoiding motor block allows us not only to provide an early rehabilitation program in the postoperative period, but also to control the chronic nociceptive activation secondary to pain-induced movement

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 20, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

Same day

First QC Date

March 17, 2023

Last Update Submit

March 17, 2023

Conditions

Outcome Measures

Primary Outcomes (9)

  • visual analogue score

    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain

    immediately after extubation

  • visual analogue score

    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain

    2 hours postoperative

  • visual analogue score

    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain

    4 hours postoperative

  • visual analogue score

    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain

    8 hours postoperative

  • visual analogue score

    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain

    12 hours postoperative

  • visual analogue score

    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain

    16 hours postoperative

  • visual analogue score

    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain

    24 hours postoperative

  • visual analogue score

    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain

    36 hours postoperative

  • visual analogue score

    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain

    48 hours postoperative

Secondary Outcomes (3)

  • Time time to first dose of rescue analgesic

    during 48 hours after operation

  • Total dose of analgesic needed

    during 48 hours after operation

  • Complications

    during 48 hours after operation

Study Arms (3)

Group A (ultrasound guided pericapsular nerve group shoulder block)

ACTIVE COMPARATOR
Procedure: ultrasound guided pericapsular nerve group shoulder block

Group B( ultrasound guided suprascapular and axillary nerve block)

ACTIVE COMPARATOR
Procedure: ultrasound guided suprascapular and axillary nerve block

control group

ACTIVE COMPARATOR
Other: general anesthesia without nerve block

Interventions

The patient's arm is placed in external rotation and abducted at 45 degrees. A linear ultrasound probe will be placed longitudinally between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle over it, a 50-mm needle will be inserted using the ''in plane'' technique. When the needle pass through the deltoid muscle and touched the subscapularis tendon, a bone-like hard tissue will be felt and the needle could not be advanced further. The needle tip will be placed between the deltoid muscle and subscapularis tendon, and 20 cc of 0.25% bupivacaine hydrochloride with 4mg dexamesathone will be injected

Group A (ultrasound guided pericapsular nerve group shoulder block)

The patient will be positioned in a semi-recumbent position with the operating arm on the contralateral shoulder. The probe will be kept over the scapular spine to identify the trapezius and the supraspinatus muscle. Then, it will be moved laterally to identify the concavity of the supraspinatus fossa and the hyper-echoic fascia of the supraspinatus muscle. In the concavity of the fossa, the suprascapular artery and the suprascapular nerve run in close proximity. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected below the supraspinatous fascia then the posterior surface of the humerus will be visualised in the short axis view. So, the AN and posterior circumflex artery will be visualised longitudinally. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected into space

Group B( ultrasound guided suprascapular and axillary nerve block)

this group will receive general anesthesia without nerve block

control group

Eligibility Criteria

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

You may qualify if:

  • Adults between age of 18 and 60 years old undergoing elective shoulder arthroscopy surgery.
  • American society of anesthesiologists classification (ASA) Ⅰ\&Ⅱ
  • Males \& Females

You may not qualify if:

  • Age: \< 18 or \> 60 years old.
  • Patients refuse to participate in the study.
  • Patients with known hypersensitivity to local anesthetics.
  • Coagulation disorder
  • Infection at the site of injection
  • Hepatic impairment
  • Renal impairment
  • Severe intraoperative bleeding affecting the hemodynamics status of the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, GeneralNerve Block

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnesthesia, ConductionDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia

Study Record Dates

First Submitted

March 17, 2023

First Posted

March 30, 2023

Study Start

May 20, 2023

Primary Completion

May 20, 2023

Study Completion

May 20, 2024

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share