NCT07057947

Brief Summary

The goal of this clinical trial is to learn if pericapsular nerve group block (PENG) in shoulder scope surgery provides adequate analgesia with less affection of muscle power compared to interscalene block. The main questions it aims to answer are: Does PENG block provide analgesia similar to interscalene block? Does PENG block have less or no effect on muscle power compared to interscalene block? Researchers will compare PENG block with interscalene block Participants will: Receive either PENG or interscalene block before shoulder scope surgery Be evaluated for their motor power after receiving the block and after the surgery Be evaluated for pain after the surgery

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 11, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

7 days

First QC Date

March 11, 2025

Last Update Submit

July 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time for full recovery of hand motor power

    Time from start of block activation till time of achieving grip strength similar to patient's baseline

    Starting from block activation until the achieves preoperative grip strength ( 24 hours)

Secondary Outcomes (4)

  • Hand grip power after surgery

    2,4,6,12,24 hours

  • Visual analogue scale assessment

    2,4,6,12 hours

  • Time to first analgesia request

    24 hours

  • Patient satisfaction score

    24 hours

Study Arms (2)

Group P

ACTIVE COMPARATOR

This arm will receive PENG block

Procedure: Pericapsular Nerve Group (PENG) BlockDevice: Acuson X300 ultrasound,Siemens medical solution INC, Germany

Group I

ACTIVE COMPARATOR

This arm will receive interscalene block

Procedure: Interscalene Nerve BlockDevice: Acuson X300 ultrasound,Siemens medical solution INC, Germany

Interventions

Injection of local anesthetic between deltoid muscle and subcapsularis tendon

Group P

Injection of local anesthetic between anterior and middle scalene muscles around the roots of brachial plexus

Group I

high frequency linear probe

Group IGroup P

Eligibility Criteria

Age22 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients of the specified age range
  • Any gender
  • American Society of Anaesthesiologists physical status grades 1 and 2
  • Body mass index less than 35
  • Duration of surgery between 90 to 120 minutes

You may not qualify if:

  • American Society of Anaesthesiologists physical status grades 3 and 4
  • Allergy to local anesthetics
  • Coagulation disorder (INR \>1.2, Platelets \<100,000), or recent intake of clopidogrel or warfarin within 1 week
  • Active infection at site of injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11562, Egypt

RECRUITING

Related Publications (11)

  • Mosaffa F, Taheri M, Manafi Rasi A, Samadpour H, Memary E, Mirkheshti A. Comparison of pericapsular nerve group (PENG) block with fascia iliaca compartment block (FICB) for pain control in hip fractures: A double-blind prospective randomized controlled clinical trial. Orthop Traumatol Surg Res. 2022 Feb;108(1):103135. doi: 10.1016/j.otsr.2021.103135. Epub 2021 Oct 29.

    PMID: 34715388BACKGROUND
  • Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

    PMID: 30063657BACKGROUND
  • 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.

    PMID: 34118263BACKGROUND
  • Hussain N, Goldar G, Ragina N, Banfield L, Laffey JG, Abdallah FW. Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2017 Dec;127(6):998-1013. doi: 10.1097/ALN.0000000000001894.

    PMID: 28968280BACKGROUND
  • Stasiowski M, Zuber M, Marciniak R, Kolny M, Chabierska E, Jalowiecki P, Pluta A, Missir A. Risk factors for the development of Horner's syndrome following interscalene brachial plexus block using ropivacaine for shoulder arthroscopy: a randomised trial. Anaesthesiol Intensive Ther. 2018;50(3):215-220. doi: 10.5603/AIT.a2018.0013. Epub 2018 Jun 22.

    PMID: 29931665BACKGROUND
  • Bergmann L, Martini S, Kesselmeier M, Armbruster W, Notheisen T, Adamzik M, Eichholz R. Phrenic nerve block caused by interscalene brachial plexus block: breathing effects of different sites of injection. BMC Anesthesiol. 2016 Jul 29;16(1):45. doi: 10.1186/s12871-016-0218-x.

    PMID: 27473162BACKGROUND
  • Paul RW, Szukics PF, Brutico J, Tjoumakaris FP, Freedman KB. Postoperative Multimodal Pain Management and Opioid Consumption in Arthroscopy Clinical Trials: A Systematic Review. Arthrosc Sports Med Rehabil. 2021 Dec 17;4(2):e721-e746. doi: 10.1016/j.asmr.2021.09.011. eCollection 2022 Apr.

    PMID: 35494281BACKGROUND
  • Guity MR, Sobhani Eraghi A, Hosseini-Baharanchi FS. Early postoperative pain as a risk factor of shoulder stiffness after arthroscopic rotator cuff repair. J Orthop Traumatol. 2021 Jun 26;22(1):25. doi: 10.1186/s10195-021-00585-9.

    PMID: 34173872BACKGROUND
  • Calvo E, Torres MD, Morcillo D, Leal V. Rotator cuff repair is more painful than other arthroscopic shoulder procedures. Arch Orthop Trauma Surg. 2019 May;139(5):669-674. doi: 10.1007/s00402-018-3100-0. Epub 2018 Dec 17.

    PMID: 30560289BACKGROUND
  • Zong LZ, Duan MM, Yuan WW, Lu HD. Efficacy of shoulder arthroscopic surgery for the treatment of rotator cuff injury: A protocol of systematic review and meta-analysis. Medicine (Baltimore). 2020 Jun 26;99(26):e20591. doi: 10.1097/MD.0000000000020591.

    PMID: 32590734BACKGROUND
  • Farmer KW, Wright TW. Shoulder arthroscopy: the basics. J Hand Surg Am. 2015 Apr;40(4):817-21. doi: 10.1016/j.jhsa.2015.01.002. Epub 2015 Feb 26.

    PMID: 25726045BACKGROUND

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Central Study Contacts

Research Ethics Committee

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Sherine Refaat Mahmoud, Assistant Professor of anesthesiology, surgical ICU and pain management

Study Record Dates

First Submitted

March 11, 2025

First Posted

July 10, 2025

Study Start

August 25, 2025

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations