Shoulder Surgeries OperationsNCT05920421
Diaphragm Sparing Effect of Subomohyoid Block With Infraclavicular or Subscapularis Blocks in Comparison With Interscalen Block for Postoperative Analgesia in Shoulder Surgeries
A study testing diaghragm affection by ultrasound before and after the blocks in people with Shoulder Surgeries Operations, run by Zagazig University at 1 site in Egypt.
Trial summary
The gold standard for shoulder analgesia is the interscalene block (ISB), but it has its own share of disadvantages such as phrenic nerve block, recurrent laryngeal nerve involvement and Horner's syndrome may lead to patient discomfort .Others, such as intrathecal spread and systemic toxicity of local anesthetic, can… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Shoulder Surgeries Operations
- What is being tested?
- diaghragm affection by ultrasound before and after the blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2023to 30 Dec 2024
- 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
- Patient acceptance.
- ASA I and ASA II.
- Age 21-60 years old.
- Both gender.
- BMI < 35 Kg/m2.
- Accepted mental state of the patient.
- Elective Unilateral upper limb surgeries at the level of the shoulder.
- Time of surgery less than 2 hours
Who cannot join
- - Patient refusal.
- Peripheral neuropathy.
- Pathological coagulopathy.
- Infection at the injection site.
- Untreated pneumothorax.
- Disturbed conscious level.
- An allergy to local anesthetics used in this study
Trial locations and contacts
1 site in 1 country.
About this study
The gold standard for shoulder analgesia is the interscalene block (ISB), but it has its own share of disadvantages such as phrenic nerve block, recurrent laryngeal nerve involvement and Horner's syndrome may lead to patient discomfort .Others, such as intrathecal spread and systemic toxicity of local anesthetic, can have serious consequences.
Phrenic nerve injury is a common complication with regional anesthesia. Its either temporary with Transient Phrenic Nerve Palsy leading to hemidiaphragmatic paresis after interscalene block or other injections of local anesthetic in the neck .
Read more
Although studies of ISB have shown a reduction in the incidence in hemidiaphragmatic paralysis with low-volume ISB, the risk of phrenic paralysis is not completely eliminated.
To bypass this complication, distal block of the shoulder innervation is recommended such as subomohyoid infraclavicular and subomohyoid subscapularis blocks.
Read the detailed description
Ultrasound has a significant role in recent anesthesia. It plays a significant role in detecting diaphragmatic mobility and detecting phrenic nerve palsy after regional anesthesia . the common and standard technique for shoulder analgesia is interscalen block. but it has its own complications like phrenic nerve palsy.
to bypass this complications ,several ways had been tried to overcome this complications.
in this study, the investigator compare between the standard interscalen block with distal blocks like infraclavicular subomohyoid block and subomohyoid subscapularis blocks according to diaghragm affection , duration of analgesia , side effects occured with blocks.
For infraclavicular subomohyoid block, the infraclavicular approach targets the posterior and lateral cords, thus anesthetizing the axillary nerve (which supplies the anterior and posterior shoulder joint), whereas the suprascapular nerve block done by blocking subomohyoid muscle anesthetizes the posterior shoulder.
For subscapularis subomohyoid block, subscapularis is done before subomohyoid block. Subscapularis block target subscapular nerve which arise from posterior cord and present on ventral surface of subscapularis muscle .
- Conditions
- Shoulder Surgeries Operations
- Being tested
- diaghragm affection by ultrasound before and after the blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaghragm affection by ultrasound before and after the blocksProcedure or surgery
the participant will assess diaphragm sparing in each block and evaluate effectiveness of infraclavicular subomohyoid blocks and subomohyoid subscapularis blocks according to intraoperative and postoperative analgesia and diaphragm affection and comparing them with interscalen and with each others
| Study group | Role | What they receive |
|---|---|---|
| interscalen group | Placebo comparator | (29) patients will receive an interscalene block before induction of general anaesthesia.
Patients will receive 20 ml of bupivacaine 0.25 %+250 mg of magnesium sulphate. Receives: Procedure: diaghragm affection by ultrasound before and after the blocks |
| subomohyoid infracavicular group | Active comparator | (29) patients will receive subomohyoid infraclavicular block before induction of general anesthesia. Patients will receive 20 ml of bupivacaine 0.25 %+250 mg of magnesium sulphate. Receives: Procedure: diaghragm affection by ultrasound before and after the blocks |
| subomohyoid subscapularis group | Active comparator | (29) patients will receive subomohyoid subscapularis block before induction of general anesthesia. Patients will receive 20 mL of 0.25% bupivacaine + 250 mg of magnesium sulfate. Receives: Procedure: diaghragm affection by ultrasound before and after the blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is being assessed (Diaphragm excursion)
As shown before diaphragm excursion will be examined preoperative as basal measurement, immediately postoperative in the PACU and 6 hours postoperatively to detect diaghragm excursion.If ratio of post to pre-block is < 25% this means that phrenic nerve block is included.
Measured: basal preoperatively , immediately postoperatively in the pacu and 6 hours postoperatively
Thickness fraction
The percentage change in thickness between end expiration and peak inspiration. It was calculated as follows: (thickness at peak inspiration - thickness at end expiration/thickness at end expiration) ×100.
Measured: basal preoperatively, immediately postoperatively in the PACU, and 6 hours postoperatively
Secondary outcomes (3)
Visual Analogue Scale (VAS) at different intervals within and between the studied groups
The investigators ask the patient to estimate the degree of pain on a scale from 1 to 10 and ask the patient to report the degree of pain from 0 to 10, with 0 no pain to 10 worst pain.
Measured: immediately postoperative in the PACU , 6 hours postoperatively up to 24 hour postoperatively
Total pethidine consumption in 24 hours of the studied groups
The investigator will calculate the total amount of pethidine consumed over a 24-hour period.
Measured: 24 hours
postoperative complication of the studied groups
the investigator will record patients with complications from the blocks like hypoxemia with saturation <90% , bradycardia with heart rate <50, nausea and vomiting
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start20 Jul 2023
- Primary completion20 Dec 2023
- Study completion30 Dec 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 Shoulder Surgeries OperationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emad Hamdy Mohamed Morsy, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920421
- Sponsor's protocol ID
- #6024/5-4-2022
- Status last verified
- Dec 2025
- First submitted
- 14 May 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after completion of the study
Publications
Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):564-71. doi: 10.1097/AAP.0000000000000436.
PubMed 27380105Battaglia PJ, Haun DW, Dooley K, Kettner NW. Sonographic measurement of the normal suprascapular nerve and omohyoid muscle. Man Ther. 2014 Apr;19(2):165-8. doi: 10.1016/j.math.2013.12.005. Epub 2013 Dec 27.
PubMed 24412231Musso D, Flohr-Madsen S, Meknas K, Wilsgaard T, Ytrebo LM, Klaastad O. A novel combination of peripheral nerve blocks for arthroscopic shoulder surgery. Acta Anaesthesiol Scand. 2017 Oct;61(9):1192-1202. doi: 10.1111/aas.12948. Epub 2017 Aug 4.
PubMed 28776638Bergmann 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.
PubMed 27473162Panero AJ, Hirahara AM. A Guide to Ultrasound of the Shoulder, Part 2: The Diagnostic Evaluation. Am J Orthop (Belle Mead NJ). 2016 May-Jun;45(4):233-8.
PubMed 27327915Boon AJ, O'Gorman C. Ultrasound in the Assessment of Respiration. J Clin Neurophysiol. 2016 Apr;33(2):112-9. doi: 10.1097/WNP.0000000000000240.
PubMed 27035251Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.
PubMed 14622683Aszmann OC, Dellon AL, Birely BT, McFarland EG. Innervation of the human shoulder joint and its implications for surgery. Clin Orthop Relat Res. 1996 Sep;(330):202-7. doi: 10.1097/00003086-199609000-00027.
PubMed 8804294
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Sparing Effect of Subomohyoid Block With Infraclavicular or Subscapularis Blocks in Comparison With Interscalen Block for Postoperative Analgesia in Shoulder Surgeries
- ClinicalTrials.gov ID
- NCT05920421
- Acronym / sponsor ID
- #6024/5-4-2022
- Conditions
- Shoulder Surgeries Operations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 27 Jun 2023 (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 gold standard for shoulder analgesia is the interscalene block (ISB), but it has its own share of disadvantages such as phrenic nerve block, recurrent laryngeal nerve involvement and Horner's syndrome may lead to patient discomfort .Others, such as intrathecal spread and systemic toxicity of local anesthetic, can have serious consequences.
Phrenic nerve injury is a common complication with regional anesthesia. Its either temporary with Transient Phrenic Nerve Palsy leading to hemidiaphragmatic paresis after interscalene block or other injections of local anesthetic in the neck .
Although studies of ISB have shown a reduction in the incidence in hemidiaphragmatic paralysis with low-volume ISB, the risk of phrenic paralysis is not completely eliminated.
To bypass this complication, distal block of the shoulder innervation is recommended such as subomohyoid infraclavicular and subomohyoid subscapularis blocks.
Detailed description
Ultrasound has a significant role in recent anesthesia. It plays a significant role in detecting diaphragmatic mobility and detecting phrenic nerve palsy after regional anesthesia . the common and standard technique for shoulder analgesia is interscalen block. but it has its own complications like phrenic nerve palsy.
to bypass this complications ,several ways had been tried to overcome this complications.
in this study, the investigator compare between the standard interscalen block with distal blocks like infraclavicular subomohyoid block and subomohyoid subscapularis blocks according to diaghragm affection , duration of analgesia , side effects occured with blocks.
For infraclavicular subomohyoid block, the infraclavicular approach targets the posterior and lateral cords, thus anesthetizing the axillary nerve (which supplies the anterior and posterior shoulder joint), whereas the suprascapular nerve block done by blocking subomohyoid muscle anesthetizes the posterior shoulder.
For subscapularis subomohyoid block, subscapularis is done before subomohyoid block. Subscapularis block target subscapular nerve which arise from posterior cord and present on ventral surface of subscapularis muscle .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| interscalen group | Placebo comparator | Procedure: diaghragm affection by ultrasound before and after the blocks(29) patients will receive an interscalene block before induction of general anaesthesia. Patients will receive 20 ml of bupivacaine 0.25 %+250 mg of magnesium sulphate. |
| subomohyoid infracavicular group | Active comparator | Procedure: diaghragm affection by ultrasound before and after the blocks(29) patients will receive subomohyoid infraclavicular block before induction of general anesthesia. Patients will receive 20 ml of bupivacaine 0.25 %+250 mg of magnesium sulphate. |
| subomohyoid subscapularis group | Active comparator | Procedure: diaghragm affection by ultrasound before and after the blocks(29) patients will receive subomohyoid subscapularis block before induction of general anesthesia. Patients will receive 20 mL of 0.25% bupivacaine + 250 mg of magnesium sulfate. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patient acceptance.
- ASA I and ASA II.
- Age 21-60 years old.
- Both gender.
- BMI < 35 Kg/m2.
Key exclusion criteria (7 listed)
- - Patient refusal.
- Peripheral neuropathy.
- Pathological coagulopathy.
- Infection at the injection site.
- Untreated pneumothorax.
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 |
|---|---|---|
| diaghragm affection by ultrasound before and after the blocksthe participant will assess diaphragm sparing in each block and evaluate effectiveness of infraclavicular subomohyoid blocks and subomohyoid subscapularis blocks according to intraoperative and postoperative analgesia and diaphragm affection and comparing them with interscalen and with each others | Procedure or surgery | interscalen group, subomohyoid infracavicular group, subomohyoid subscapularis group |
Primary outcome
Change is being assessed (Diaphragm excursion)
Time frame: basal preoperatively , immediately postoperatively in the pacu and 6 hours postoperatively
As shown before diaphragm excursion will be examined preoperative as basal measurement, immediately postoperative in the PACU and 6 hours postoperatively to detect diaghragm excursion.If ratio of post to pre-block is < 25% this means that phrenic nerve block is included.
Thickness fraction
Time frame: basal preoperatively, immediately postoperatively in the PACU, and 6 hours postoperatively
The percentage change in thickness between end expiration and peak inspiration. It was calculated as follows: (thickness at peak inspiration - thickness at end expiration/thickness at end expiration) ×100.
3 secondary outcomes
Visual Analogue Scale (VAS) at different intervals within and between the studied groups
Time frame: immediately postoperative in the PACU , 6 hours postoperatively up to 24 hour postoperatively
Total pethidine consumption in 24 hours of the studied groups
Time frame: 24 hours
postoperative complication of the studied groups
Time frame: 24 hours
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 2 Jan 2026.
- Background: PubMed 27380105Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):564-71. doi: 10.1097/AAP.0000000000000436.
- Background: PubMed 24412231Battaglia PJ, Haun DW, Dooley K, Kettner NW. Sonographic measurement of the normal suprascapular nerve and omohyoid muscle. Man Ther. 2014 Apr;19(2):165-8. doi: 10.1016/j.math.2013.12.005. Epub 2013 Dec 27.
- Background: PubMed 28776638Musso D, Flohr-Madsen S, Meknas K, Wilsgaard T, Ytrebo LM, Klaastad O. A novel combination of peripheral nerve blocks for arthroscopic shoulder surgery. Acta Anaesthesiol Scand. 2017 Oct;61(9):1192-1202. doi: 10.1111/aas.12948. Epub 2017 Aug 4.
- Background: PubMed 27473162Bergmann 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.
- Background: PubMed 27327915Panero AJ, Hirahara AM. A Guide to Ultrasound of the Shoulder, Part 2: The Diagnostic Evaluation. Am J Orthop (Belle Mead NJ). 2016 May-Jun;45(4):233-8.
- Background: PubMed 27035251Boon AJ, O'Gorman C. Ultrasound in the Assessment of Respiration. J Clin Neurophysiol. 2016 Apr;33(2):112-9. doi: 10.1097/WNP.0000000000000240.
- Background: PubMed 14622683Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.
- Results publication: PubMed 8804294Aszmann OC, Dellon AL, Birely BT, McFarland EG. Innervation of the human shoulder joint and its implications for surgery. Clin Orthop Relat Res. 1996 Sep;(330):202-7. doi: 10.1097/00003086-199609000-00027.
- Individual participant dataSharing planned: Yes. planned after completion of the study
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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 diaghragm affection by ultrasound before and after the blocks in people with Shoulder Surgeries Operations, 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 8 inclusion and 7 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 2 Jan 2026. 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?
Change is being assessed (Diaphragm excursion) (time frame: basal preoperatively , immediately postoperatively in the pacu and 6 hours postoperatively). The study lists 2 primary outcomes in all. 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 NCT05920421, 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 2 Jan 2026.