Arthroscopic Shoulder SurgeryNCT04669639
A Comparison of ESP Block to SSN Block for Analgesia in Shoulder Surgery
A study testing Block procedures for shoulder surgery analgesia in people with Arthroscopic Shoulder Surgery, run by Zagazig University at 1 site in Egypt.
Trial summary
A comparison between Erector Spinae Plane block and Suprascapular nerve block in providing analgesia for shoulder surgery Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Arthroscopic Shoulder Surgery
- What is being tested?
- Block procedures for shoulder surgery analgesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2020to 10 Nov 2021
- Phase
- Interventional
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I and II,
- Age above 21 years and below 60 years in both sexes,
- Cooperative patients,
- Patients with a BMI (body mass index) not exceeding 35.
Who cannot join
- patients with cardiovascular or respiratory compromise,
- Patient refusal,
- Coagulopathy,
- Local tissue infection,
- Allergy to local anesthesia,
- prior to cervical or thoracic spine surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Erector Spinae Plane Block to Suprascapular Nerve Block for Analgesia in Shoulder Surgery
A comparison between Erector Spinae Plane block and Suprascapular nerve block in providing analgesia for shoulder surgery
Read the detailed description
Suprascapular nerve block is considered a phrenic nerve sparing approach that recently introduced as alternative for interscalene brachial plexus nerve block in shoulder surgery. However, some researchers reported that Suprascapular nerve block alone results in an ineffective analgesia. Erector Spinae Plane block is supposed to be able in providing adequate analgesia in shoulder surgery
- Conditions
- Arthroscopic Shoulder Surgery
- Being tested
- Block procedures for shoulder surgery analgesia
- Keywords
- erector spinae plane block- suprascapular nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Block procedures for shoulder surgery analgesiaOther
The patients in group (a) will be placed in lateral decubitus. Then, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used to locate the transverse process of T2, where a needle will be inserted in a cephalocaudal direction until reaching the space between the fascia of the erector spinae and the transverse process of T2 and 30 ml of local anesthetic of bupivacaine 0.5% will be injected.
- In group (b), SSC nerve block will be done as follow: In the suprascapular notch, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used. The linear probe, enveloped in a sterile sheath, will be placed parallel to the spine of the scapula to visualize it and then will be moved cephalic to the supraspinatus fossa. The probe will then be moved laterally up to the scapular notch, where the nerve will be identified by its round hyperechogenic shape 4 cm deep.
- control group: patients will receive only general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| The block group (a) | Experimental | Patients were randomized in a 1:1 :1ratio, group (a) will receive SSN. The nerve blocks The procedure will be performed after induction of anaesthesia and endotracheal intubation. Receives: Other: Block procedures for shoulder surgery analgesia |
| The block group (b) | Experimental | Patients were randomized in a 1:1:1 ratio. group (b) will receive the Erector spinae plane block. The procedure will be performed after induction of anesthesia and endotracheal intubation. Receives: Other: Block procedures for shoulder surgery analgesia |
| control group | Placebo comparator | Patients were randomized in a 1:1:1 ratio. this group will receive general anesthesia (GA) only Receives: Other: Block procedures for shoulder surgery analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative analgesia
Recording of the patients' hemodynamics (heart rate and non-invasive blood pressure) and total dose of opioids consumption intraoperatively and postoperatively.
Measured: The intraoperative patients' hemodynamics every 30 min were collected and analyzed till the end of surgery . Also the total dose of opioids consumed intraoperatively will be recorded. Postoperative consumed opioid for 24 hours also will calculated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start20 Dec 2020
- Primary completion10 Sep 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Arthroscopic Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There has been a recent renewed interest in using the suprascapular nerve block (SSNB) as a phrenic nerve sparing approach for analgesia after shoulder surgery. The suprascapular nerve provides 70% of the sensory input to the glenohumeral joint and also innervates the infraspinatus and supraspinatus muscles. However, some researchers suggest that SSNB alone cannot provide a sufficient analgesia.The high-thoracic erector spinae plane block (HT-ESPB) has been described in several case reports as an effective analgesic modality for the shoulder region without causing motor or phrenic nerve block
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Naglaa Fathy Abdelhaleem Abdelhaleem, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669639
- Sponsor's protocol ID
- #6506
- Status last verified
- Nov 2020
- First submitted
- 25 Nov 2020
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available when the study is finished and the paper is published
Publications
Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
PubMed 2006740Ma W, Sun L, Ngai L, Costouros JG, Steffner R, Boublik J, Tsui BCH. Motor-sparing high-thoracic erector spinae plane block for proximal humerus surgery and total shoulder arthroplasty surgery: clinical evidence for differential peripheral nerve block? Can J Anaesth. 2019 Oct;66(10):1274-1275. doi: 10.1007/s12630-019-01442-4. Epub 2019 Jul 9. No abstract available.
PubMed 31290120Hussain 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.
PubMed 28968280Abdelhaleem NF, Abdelatiff SE, Abdel Naby SM. Comparison of Erector Spinae Plane Block at the Level of the Second Thoracic Vertebra With Suprascapular Nerve Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery. Pain Physician. 2022 Nov;25(8):577-585.
PubMed 36375187
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Erector Spinae Plane Block to Suprascapular Nerve Block for Analgesia in Shoulder Surgery
- ClinicalTrials.gov ID
- NCT04669639
- Acronym / sponsor ID
- #6506
- Conditions
- Arthroscopic Shoulder Surgery
- Keywords
- erector spinae plane block- suprascapular nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 17 Dec 2020 (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.
A comparison between Erector Spinae Plane block and Suprascapular nerve block in providing analgesia for shoulder surgery
Detailed description
Suprascapular nerve block is considered a phrenic nerve sparing approach that recently introduced as alternative for interscalene brachial plexus nerve block in shoulder surgery. However, some researchers reported that Suprascapular nerve block alone results in an ineffective analgesia. Erector Spinae Plane block is supposed to be able in providing adequate analgesia in shoulder surgery
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- There has been a recent renewed interest in using the suprascapular nerve block (SSNB) as a phrenic nerve sparing approach for analgesia after shoulder surgery. The suprascapular nerve provides 70% of the sensory input to the glenohumeral joint and also innervates the infraspinatus and supraspinatus muscles. However, some researchers suggest that SSNB alone cannot provide a sufficient analgesia.The high-thoracic erector spinae plane block (HT-ESPB) has been described in several case reports as an effective analgesic modality for the shoulder region without causing motor or phrenic nerve block
| Arm | Type | Receives |
|---|---|---|
| The block group (a) | Experimental | Other: Block procedures for shoulder surgery analgesiaPatients were randomized in a 1:1 :1ratio, group (a) will receive SSN. The nerve blocks The procedure will be performed after induction of anaesthesia and endotracheal intubation. |
| The block group (b) | Experimental | Other: Block procedures for shoulder surgery analgesiaPatients were randomized in a 1:1:1 ratio. group (b) will receive the Erector spinae plane block. The procedure will be performed after induction of anesthesia and endotracheal intubation. |
| control group | Placebo comparator | Other: Block procedures for shoulder surgery analgesiaPatients were randomized in a 1:1:1 ratio. this group will receive general anesthesia (GA) only |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I and II,
- Age above 21 years and below 60 years in both sexes,
- Cooperative patients,
- Patients with a BMI (body mass index) not exceeding 35.
Key exclusion criteria (6 listed)
- patients with cardiovascular or respiratory compromise,
- Patient refusal,
- Coagulopathy,
- Local tissue infection,
- Allergy to local anesthesia,
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 |
|---|---|---|
| Block procedures for shoulder surgery analgesiaThe patients in group (a) will be placed in lateral decubitus. Then, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used to locate the transverse process of T2, where a needle will be inserted in a cephalocaudal direction until reaching the space between the fascia of the erector spinae and the transverse process of T2 and 30 ml of local anesthetic of bupivacaine 0.5% will be injected. * In group (b), SSC nerve block will be done as follow: In the suprascapular notch, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used. The linear probe, enveloped in a sterile sheath, will be placed parallel to the spine of the scapula to visualize it and then will be moved cephalic to the supraspinatus fossa. The probe will then be moved laterally up to the scapular notch, where the nerve will be identified by its round hyperechogenic shape 4 cm deep. * control group: patients will receive only general anesthesia | Other | The block group (a), The block group (b), control group |
Primary outcome
Intraoperative analgesia
Time frame: The intraoperative patients' hemodynamics every 30 min were collected and analyzed till the end of surgery . Also the total dose of opioids consumed intraoperatively will be recorded. Postoperative consumed opioid for 24 hours also will calculated
Recording of the patients' hemodynamics (heart rate and non-invasive blood pressure) and total dose of opioids consumption intraoperatively and postoperatively.
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 24 May 2022.
- Background: PubMed 2006740Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
- Background: PubMed 31290120Ma W, Sun L, Ngai L, Costouros JG, Steffner R, Boublik J, Tsui BCH. Motor-sparing high-thoracic erector spinae plane block for proximal humerus surgery and total shoulder arthroplasty surgery: clinical evidence for differential peripheral nerve block? Can J Anaesth. 2019 Oct;66(10):1274-1275. doi: 10.1007/s12630-019-01442-4. Epub 2019 Jul 9. No abstract available.
- Background: PubMed 28968280Hussain 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.
- Derived from this study: PubMed 36375187Abdelhaleem NF, Abdelatiff SE, Abdel Naby SM. Comparison of Erector Spinae Plane Block at the Level of the Second Thoracic Vertebra With Suprascapular Nerve Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery. Pain Physician. 2022 Nov;25(8):577-585.
- Individual participant dataSharing planned: Yes. The data will be available when the study is finished and the paper is published
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Block procedures for shoulder surgery analgesia in people with Arthroscopic Shoulder Surgery, run by Zagazig University at 1 site in Egypt.
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 4 inclusion and 6 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 24 May 2022. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Intraoperative analgesia (time frame: The intraoperative patients' hemodynamics every 30 min were collected and analyzed till the end of surgery . Also the total dose of opioids consumed intraoperatively will be recorded. Postoperative consumed opioid for 24 hours also will calculated). 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 NCT04669639, which also lists 4 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 24 May 2022.