NCT06611761

Brief Summary

The purpose of this study was to evaluate the analgesic efficacy of suprascapular and axillary nerve block for shoulder arthroscopy surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

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

Study Start

First participant enrolled

October 12, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

September 22, 2024

Last Update Submit

September 24, 2024

Conditions

Keywords

shoulder arthroscopysuprascapular nerveaxillary nervemultimodal analgesic strategies

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    The measurement of pain intensity according to the numerical rating scale (NRS) from 0 (absence of pain) to 10 (maximum pain endured)

    The measurement of pain intensity according to the numerical rating scale at preoperative and at the 1st, 2nd, 12th ant 24th postoperative hours

Study Arms (2)

SHAC block + anterior SSN block

Group of patients undergoing shoulder arthroscopy who underwent a block of the anterior capsule of the shoulder (SHAC block) with the suprascapular nerve block (SSN block) performed via an anterior approach with 20 ml of 0.20% ropivacaine

Procedure: Shoulder arthroscopy

Posterior SSN + AN blocks

Group of patients undergoing shoulder arthroscopy who underwent a suprascapular and axillary nerve block performed via a posterior approach with 20 ml of 0.20% ropivacaine

Procedure: Shoulder arthroscopy

Interventions

Shoulder arthroscopy in procedures that cause intense postoperative pain

Posterior SSN + AN blocksSHAC block + anterior SSN block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

After approval of the study by Galician Drug Research Ethics Committee, Spain (CEIm-G) and obtaining informed consent from the participants, patients undergoing shoulder arthroscopy surgery consecutively over the course of one year were included who met the study inclusion criteria.

You may qualify if:

  • Patients over 18 years of age.
  • ASA (Physical Status Classification System) I - III.
  • Having been scheduled for shoulder arthroscopy surgery.

You may not qualify if:

  • Any contraindication for performing regional anesthetic techniques:
  • Infection at the puncture point.
  • Alteration of hemostasis.
  • Allergy to local anesthetics.
  • Patient refusal to participate in the study.
  • Inability to evaluate postoperative pain.
  • Known neuropathy of the operated limb.
  • Patients who required conversion to open surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FINBA

Oviedo, Principality of Asturias, 33001, Spain

Location

Related Publications (8)

  • Laumonerie P, Dalmas Y, Tibbo ME, Robert S, Faruch M, Chaynes P, Bonnevialle N, Mansat P. Sensory innervation of the human shoulder joint: the three bridges to break. J Shoulder Elbow Surg. 2020 Dec;29(12):e499-e507. doi: 10.1016/j.jse.2020.07.017. Epub 2020 Jul 23.

    PMID: 32712453BACKGROUND
  • Yamak Altinpulluk E, Teles AS, Galluccio F, Simon DG, Olea MS, Salazar C, Fajardo Perez M. Pericapsular nerve group block for postoperative shoulder pain: A cadaveric radiological evaluation. J Clin Anesth. 2020 Dec;67:110058. doi: 10.1016/j.jclinane.2020.110058. Epub 2020 Sep 26. No abstract available.

    PMID: 32987232BACKGROUND
  • Eckmann MS, Bickelhaupt B, Fehl J, Benfield JA, Curley J, Rahimi O, Nagpal AS. Cadaveric Study of the Articular Branches of the Shoulder Joint. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):564-570. doi: 10.1097/AAP.0000000000000652.

    PMID: 28786899BACKGROUND
  • Gonzalez-Arnay E, Jimenez-Sanchez L, Garcia-Simon D, Valdes-Vilches L, Salazar-Zamorano CH, Boada-Pie S, Aguirre JA, Eichenberger U, Fajardo-Perez M. Ultrasonography-guided anterior approach for axillary nerve blockade: An anatomical study. Clin Anat. 2020 May;33(4):488-499. doi: 10.1002/ca.23394. Epub 2019 May 15.

    PMID: 31050830BACKGROUND
  • Checcucci G, Allegra A, Bigazzi P, Gianesello L, Ceruso M, Gritti G. A new technique for regional anesthesia for arthroscopic shoulder surgery based on a suprascapular nerve block and an axillary nerve block: an evaluation of the first results. Arthroscopy. 2008 Jun;24(6):689-96. doi: 10.1016/j.arthro.2008.01.019. Epub 2008 Mar 21.

  • Galluccio F, Fajardo Perez M, Yamak Altinpulluk E, Hou JD, Lin JA. Evaluation of Interfascial Plane and Pericapsular Nerve Blocks to the Shoulder Joint: A Preliminary Analysis of Shoulder Anterior Capsular Block. Pain Ther. 2021 Dec;10(2):1741-1754. doi: 10.1007/s40122-021-00326-0. Epub 2021 Oct 20.

  • Neuts A, Stessel B, Wouters PF, Dierickx C, Cools W, Ory JP, Dubois J, Jamaer L, Arijs I, Schoorens D. Selective Suprascapular and Axillary Nerve Block Versus Interscalene Plexus Block for Pain Control After Arthroscopic Shoulder Surgery: A Noninferiority Randomized Parallel-Controlled Clinical Trial. Reg Anesth Pain Med. 2018 Oct;43(7):738-744. doi: 10.1097/AAP.0000000000000777.

  • Sun C, Zhang X, Ji X, Yu P, Cai X, Yang H. Suprascapular nerve block and axillary nerve block versus interscalene nerve block for arthroscopic shoulder surgery: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2021 Nov 5;100(44):e27661. doi: 10.1097/MD.0000000000027661.

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bárbara María Jiménez Gómez, MD

    Central University Hospital of Asturias, 33001, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 22, 2024

First Posted

September 25, 2024

Study Start

October 12, 2023

Primary Completion

September 2, 2024

Study Completion

September 2, 2024

Last Updated

September 26, 2024

Record last verified: 2024-09

Locations