NCT05755802

Brief Summary

Effective analgesia in arthroscopic shoulder surgery is a major concern and is essential for all aspects of the patient's recovery. The aim of this study is to assess the quality of pain relief in patients who will undergo arthroscopic shoulder surgeries receiving either shoulder block versus PENG block comparing and evaluating the differences between the two techniques.It is hypothesized that PENG block will be comparable to shoulder block as a promising effective alternative for analgesia for arthroscopic shoulder surgeries with fewer side effects. It is suggested that the PENG block can be safely applied for analgesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 5, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

February 23, 2023

Last Update Submit

March 18, 2024

Conditions

Keywords

Pericapsular nerve group block

Outcome Measures

Primary Outcomes (1)

  • First analgesic request

    The time of the first analgesic request for fentanyl will be recorded.

    Up to 24 hours after the procedure

Secondary Outcomes (5)

  • Visual analogue score (VAS) for pain assessment

    Up to 24 hours after the procedure

  • Total analgesic requirements of fentanyl

    Up to 24 hours after the procedure

  • Heart rate (HR)

    During the procedure

  • Mean arterial blood pressure (MAP)

    During the procedure

  • Adverse effects

    Up to 24 hours after the procedure

Study Arms (2)

Group A (PENG block)

ACTIVE COMPARATOR

Ultrasound-guided PENG block will be performed under strict aseptic precautions and patient's arm will be placed in external rotation and abducted at 45 degrees.

Procedure: PENG block

Group B (Shoulder block)

ACTIVE COMPARATOR

Ultrasound-guided shoulder block will be performed under strict aseptic precautions with patient in semi-recumbent position with the operating arm on the contra-lateral shoulder.and then, the patients will be positioned in a semi-recumbent position with the arm slightly flexed and adducted at the elbow for axillary nerve block.

Procedure: Shoulder block

Interventions

PENG blockPROCEDURE

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, the needle will be inserted using the "in plane" technique. When the needle will have passed 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 the injectate will be slowly administered.

Group A (PENG block)

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. A 50 mm nerve block needle will be used in the long axis view for the block. After confirming extravascular placement of the needle, injectate will be given below the supraspinatus fascia and then during axillary nerve block,The posterior surface of the humerus will be visualised in the short axis view. So, the circumflex artery will be visualised longitudinally. After confirming extra-vascular placement of the needle, injectate will be given into space.

Group B (Shoulder block)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiology (ASA) 1 or 2 patients.
  • Scheduled for elective unilateral shoulder arthroscopy.

You may not qualify if:

  • Patient's refusal.
  • Altered mental status or un-cooperative patients.
  • History of known sensitivity to the used anesthetics.
  • Bleeding or coagulation diathesis.
  • Infection or redness at the injection site.
  • Significant cardiac dysfunction, hepatic, or renal impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 35511, Egypt

Location

Related Publications (8)

  • Casas Reza P, Dieguez Garcia P, Gestal Vazquez M, Sampayo Rodriguez L, Lopez Alvarez S. Pericapsular nerve group block for hip surgery. Minerva Anestesiol. 2020 Apr;86(4):463-465. doi: 10.23736/S0375-9393.20.14166-X. Epub 2020 Jan 28. No abstract available.

  • van Erp JHJ, Ostendorf M, Lansdaal JR. Shoulder surgery in beach chair position causing perioperative stroke: Four cases and a review of the literature. J Orthop. 2019 May 27;16(6):493-495. doi: 10.1016/j.jor.2019.05.009. eCollection 2019 Nov-Dec.

  • Kapukaya F, Ekinci M, Ciftci B, Atalay YO, Golboyu BE, Kuyucu E, Demiraran Y. Erector spinae plane block vs interscalene brachial plexus block for postoperative analgesia management in patients who underwent shoulder arthroscopy. BMC Anesthesiol. 2022 May 12;22(1):142. doi: 10.1186/s12871-022-01687-5.

  • Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.

  • Pani N, Routray SS, Pani S, Mallik S, Pattnaik S, Pradhan A. Post-operative analgesia for shoulder arthroscopic surgeries: A comparison between inter-scalene block and shoulder block. Indian J Anaesth. 2019 May;63(5):382-387. doi: 10.4103/ija.IJA_65_19.

  • Patel MS, Abboud JA, Sethi PM. Perioperative pain management for shoulder surgery: evolving techniques. J Shoulder Elbow Surg. 2020 Nov;29(11):e416-e433. doi: 10.1016/j.jse.2020.04.049. Epub 2020 Jun 9.

  • Sahin A, Baran O, Cetin MU, Gultekin A, Arar MC. Combined suprascapular nerve block and axillary nerve block approach vs. peri-articular infiltration analgesia for postoperative pain management following arthroscopic shoulder surgery: a randomized clinical trial. Eur Rev Med Pharmacol Sci. 2022 Dec;26(24):9117-9125. doi: 10.26355/eurrev_202212_30661.

  • Sripada R, Bowens C Jr. Regional anesthesia procedures for shoulder and upper arm surgery upper extremity update--2005 to present. Int Anesthesiol Clin. 2012 Winter;50(1):26-46. doi: 10.1097/AIA.0b013e31821a0284.

Study Officials

  • Amany H EL-Deeb, MD

    Faculty of Medicine, Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation, perform the block, and administer bupivacaine solution
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized, double blind study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 6, 2023

Study Start

June 5, 2023

Primary Completion

February 5, 2024

Study Completion

March 18, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations