Post Operative PainNCT05796778
Sub Omohyoid Suprascapular Nerve Block Versus Interscalene Nerve Block
A study testing subomohyoid plane block and Interscalene brachial plexus block in people with Post Operative Pain and Regional Anesthesia, run by Minia University at 1 site in Egypt.
Trial summary
Shoulder surgery can be very painful surgery after which the use of opioids is often required. The well-known side-effects of opioids (e.g. respiratory depression, somnolence, nausea, vomiting, and pruritus) limit their use in so called 'fast track' surgery and anaesthesia programmes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Operative Pain, Regional Anesthesia, Nerve Block
- What is being tested?
- subomohyoid plane block and Interscalene brachial plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Dec 2023
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-60 years.
- ASA I-II.
- Both sexes.
- Shoulder surgery.
Who cannot join
- Patient refusal
- Allergy to local anesthetics
- BMI >40 kg/m2
- Bleeding diathesis or history of anticoagulant use.
- Psychiatric diseases.
- Infection of the skin at the site of needle punctures area.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia University Hospital
Minya, 61511
hassan m. hetta, lecturer, 1010901114 ext. 0020, hassan.hetta@mu.edu.eg
About this study
Official title: Sub Omohyoid Suprascapular Nerve Block Versus Interscalene Nerve Block for Postoperative Shoulder Surgery Pain: Randomized Comparative Study.
Shoulder surgery can be very painful surgery after which the use of opioids is often required. The well-known side-effects of opioids (e.g. respiratory depression, somnolence, nausea, vomiting, and pruritus) limit their use in so called 'fast track' surgery and anaesthesia programmes.
the study aimed to compare the effect of sub omohyoid suprascapular nerve block versus interscalene nerve block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for shoulder surgery
- Conditions
- Post Operative Pain, Regional Anesthesia, Nerve Block
- Being tested
- subomohyoid plane block, Interscalene brachial plexus block
- Keywords
- Interscalene brachial plexus block, shoulder pain, subomohyoid plane block
- Medical subject headings
- Pain, Postoperative, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subomohyoid plane blockProcedure or surgery
The block needle was inserted in line with the probe in a lateral-to-medial orientation toward the suprascapular nerve. Local anesthetic solution was then injected after negative aspiration for blood to achieve circumferential spread around the neurovascular bundle
Interscalene brachial plexus blockProcedure or surgery
The block needle is usually advanced in plane in a lateral-to-medial direction through the middle scalene muscle to contact the nerve roots and inject local anesthetic around them.
| Study group | Role | What they receive |
|---|---|---|
| subomohyoid suprascapular nerve | Experimental | superficial probe of ultrasound was placed in the transverse plane to visualize the superior trunk in the short axis. The suprascapular nerve was identified as it branched off from the superior trunk and traced until it coursed beneath the inferior belly of the omohyoid muscle. Receives: Procedure: subomohyoid plane block |
| Interscalene brachial plexus | Active comparator | ultrasound-guided interscalene block involves imaging the C5 and C6 roots at approximately the level of the cricoid cartilage, just distal to where they emerge from behind their respective transverse processes and where they lie in the groove between the anterior and middle scalene muscles Receives: Procedure: Interscalene brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain score
pain score from 0 to 10 which mean 0 no pain and 10 the worst pain ever
Measured: 24 hour
Secondary outcomes (3)
Time of first analgesic request
the time of first demand rescue analgesia
Measured: 24 hour
Total analgesic consumption
total fentanyl demand
Measured: 24 hour
Incidence of any side effects
oxygen desaturation, pneumothorax, dyspnea, and phrenic nerve palsy, block, and opioid-related side effects
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Apr 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mokhtar Elshorbagy Hetta, Minia University
- Investigators
- hassan m. hetta, lecturer, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796778
- Sponsor's protocol ID
- 685/2023
- Status last verified
- Oct 2023
- First submitted
- 21 Mar 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub Omohyoid Suprascapular Nerve Block Versus Interscalene Nerve Block for Postoperative Shoulder Surgery Pain: Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT05796778
- Acronym / sponsor ID
- 685/2023
- Conditions
- Post Operative Pain, Regional Anesthesia, Nerve Block
- Keywords
- Interscalene brachial plexus block, shoulder pain, subomohyoid plane block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 4 Apr 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.
Shoulder surgery can be very painful surgery after which the use of opioids is often required. The well-known side-effects of opioids (e.g. respiratory depression, somnolence, nausea, vomiting, and pruritus) limit their use in so called 'fast track' surgery and anaesthesia programmes.
the study aimed to compare the effect of sub omohyoid suprascapular nerve block versus interscalene nerve block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for shoulder surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subomohyoid suprascapular nerve | Experimental | Procedure: subomohyoid plane blocksuperficial probe of ultrasound was placed in the transverse plane to visualize the superior trunk in the short axis. The suprascapular nerve was identified as it branched off from the superior trunk and traced until it coursed beneath the inferior belly of the omohyoid muscle. |
| Interscalene brachial plexus | Active comparator | Procedure: Interscalene brachial plexus blockultrasound-guided interscalene block involves imaging the C5 and C6 roots at approximately the level of the cricoid cartilage, just distal to where they emerge from behind their respective transverse processes and where they lie in the groove between the anterior and middle scalene muscles |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-60 years.
- ASA I-II.
- Both sexes.
- Shoulder surgery.
Key exclusion criteria (6 listed)
- Patient refusal
- Allergy to local anesthetics
- BMI >40 kg/m2
- Bleeding diathesis or history of anticoagulant use.
- Psychiatric diseases.
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 |
|---|---|---|
| subomohyoid plane blockThe block needle was inserted in line with the probe in a lateral-to-medial orientation toward the suprascapular nerve. Local anesthetic solution was then injected after negative aspiration for blood to achieve circumferential spread around the neurovascular bundle | Procedure or surgery | subomohyoid suprascapular nerve |
| Interscalene brachial plexus blockThe block needle is usually advanced in plane in a lateral-to-medial direction through the middle scalene muscle to contact the nerve roots and inject local anesthetic around them. | Procedure or surgery | Interscalene brachial plexus |
Primary outcome
Visual analogue pain score
Time frame: 24 hour
pain score from 0 to 10 which mean 0 no pain and 10 the worst pain ever
3 secondary outcomes
Time of first analgesic request
Time frame: 24 hour
Total analgesic consumption
Time frame: 24 hour
Incidence of any side effects
Time frame: 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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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.
hassan m. hetta, lecturer principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subomohyoid plane block and Interscalene brachial plexus block in people with Post Operative Pain and Regional Anesthesia, run by Minia 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: status not confirmed, as of the sponsor's last update on 19 Oct 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hassan m. hetta, lecturer (1010901114 ext. 0020, hassan.hetta@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue pain score (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2023.