AnalgesiaNCT06611761
Prospective Observational Study on the Analgesic Effectiveness of Blocking the Suprascapular and Axillary Nerves in Shoulder Arthroscopy.
An observational study of Analgesia and Shoulder Arthropathy Associated With Other Conditions, run by Jose Manuel López González at 1 site in Spain.
Trial summary
The purpose of this study was to evaluate the analgesic efficacy of suprascapular and axillary nerve block for shoulder arthroscopy surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Shoulder Arthropathy Associated With Other Conditions, Suprascapular and Axillary Nerve Block
- What is being tested?
- Shoulder arthroscopy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 166 participants
- Where
- 1 siteSpain
- Study dates
- 12 Oct 2023to 2 Sep 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients over 18 years of age.
- ASA (Physical Status Classification System) I - III.
- Having been scheduled for shoulder arthroscopy surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study on the Analgesic Effectiveness of Blocking the Shoulder´s Anterior Capsule and the Suprascapular Nerve by the Anterior Approach Versus Blocking of the Suprascapular and Axillary Nerves by the Posterior Approach in Shoulder Arthroscopy.
The purpose of this study was to evaluate the analgesic efficacy of suprascapular and axillary nerve block for shoulder arthroscopy surgery
Read the detailed description
An observational study of paired cohorts, not randomized, was designed with the aim of comparing the postoperative analgesic effectiveness of two regional analgesic techniques: the shoulder anterior capsular block associated with the suprascapular nerve block performed via an anterior approach versus the suprascapular and axillary nerve blocks performed posteriorly in patients with shoulder surgery via arthroscopy in procedures that cause intense postoperative pain.
- Conditions
- Analgesia, Shoulder Arthropathy Associated With Other Conditions, Suprascapular and Axillary Nerve Block
- Being tested
- Shoulder arthroscopy
- Keywords
- shoulder arthroscopy, suprascapular nerve, axillary nerve, multimodal analgesic strategies
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder arthroscopyProcedure or surgery
Shoulder arthroscopy in procedures that cause intense postoperative pain
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Shoulder arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
The measurement of pain intensity according to the numerical rating scale (NRS) from 0 (absence of pain) to 10 (maximum pain endured)
Measured: The measurement of pain intensity according to the numerical rating scale at preoperative and at the 1st, 2nd, 12th ant 24th postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start12 Oct 2023
- Primary completion2 Sep 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Jose Manuel López González
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Manuel López González, Fundación para la Investigación Biosanitaria del Principado de Asturias
- Investigators
- Bárbara María Jiménez Gómez, MD, Principal investigator, Central University Hospital of Asturias, 33001, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611761
- Sponsor's protocol ID
- 2023/491
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32712453Yamak 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.
PubMed 32987232Eckmann 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.
PubMed 28786899Gonzalez-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.
PubMed 31050830Checcucci 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.
PubMed 18514113Galluccio 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.
PubMed 34669181Neuts 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.
PubMed 29659438Sun 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.
PubMed 34871240
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on the Analgesic Effectiveness of Blocking the Shoulder´s Anterior Capsule and the Suprascapular Nerve by the Anterior Approach Versus Blocking of the Suprascapular and Axillary Nerves by the Posterior Approach in Shoulder Arthroscopy.
- ClinicalTrials.gov ID
- NCT06611761
- Acronym / sponsor ID
- 2023/491
- Conditions
- Analgesia, Shoulder Arthropathy Associated With Other Conditions, Suprascapular and Axillary Nerve Block
- Keywords
- shoulder arthroscopy, suprascapular nerve, axillary nerve, multimodal analgesic strategies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Jose Manuel López GonzálezUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the analgesic efficacy of suprascapular and axillary nerve block for shoulder arthroscopy surgery
Detailed description
An observational study of paired cohorts, not randomized, was designed with the aim of comparing the postoperative analgesic effectiveness of two regional analgesic techniques: the shoulder anterior capsular block associated with the suprascapular nerve block performed via an anterior approach versus the suprascapular and axillary nerve blocks performed posteriorly in patients with shoulder surgery via arthroscopy in procedures that cause intense postoperative pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHAC block + anterior SSN block | – | Procedure: Shoulder arthroscopyGroup 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 |
| Posterior SSN + AN blocks | – | Procedure: Shoulder arthroscopyGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients over 18 years of age.
- ASA (Physical Status Classification System) I - III.
- Having been scheduled for shoulder arthroscopy surgery.
Key exclusion criteria (8 listed)
- Infection at the puncture point.
- Alteration of hemostasis.
- Allergy to local anesthetics.
- Patient refusal to participate in the study.
- Inability to evaluate postoperative pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder arthroscopyShoulder arthroscopy in procedures that cause intense postoperative pain | Procedure or surgery | Posterior SSN + AN blocks, SHAC block + anterior SSN block |
Primary outcome
Postoperative pain
Time frame: The measurement of pain intensity according to the numerical rating scale at preoperative and at the 1st, 2nd, 12th ant 24th postoperative hours
The measurement of pain intensity according to the numerical rating scale (NRS) from 0 (absence of pain) to 10 (maximum pain endured)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 32712453Laumonerie 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.
- Background: PubMed 32987232Yamak 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.
- Background: PubMed 28786899Eckmann 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.
- Background: PubMed 31050830Gonzalez-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.
- Results publication: PubMed 18514113Checcucci 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.
- Results publication: PubMed 34669181Galluccio 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.
- Results publication: PubMed 29659438Neuts 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.
- Results publication: PubMed 34871240Sun 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.
- Individual participant dataSharing planned: Undecided
Related trials for Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bárbara María Jiménez Gómez, MD principal investigator
Central University Hospital of Asturias, 33001, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia and Shoulder Arthropathy Associated With Other Conditions, run by Jose Manuel López González at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: The measurement of pain intensity according to the numerical rating scale at preoperative and at the 1st, 2nd, 12th ant 24th postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611761, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.