Post Operative PainNCT05686395
Pain Control After Arthroscopic Shoulder Surgeries
A study testing Ultrasound-guided Interscalene Block group, Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block and Bupivacaine in people with Post Operative Pain, run by Tanta University at 1 site in Egypt.
Trial summary
This study will be conducted to compare the perioperative analgesic efficacy of ultrasound - guided interscalene brachial plexus block versus combined shoulder anterior capsular block and anterior suprascapular nerve block for arthroscopic shoulder surgeries. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Ultrasound-guided Interscalene Block group, Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jan 2023to 11 Aug 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20-65 years of both sexes, with American Society of Anesthesiologists (ASA) physical status I or II admitted for arthroscopic shoulder surgery.
Who cannot join
- Patient refusal.
- Uncooperative patient.
- Patient with neurological deficit.
- Patients with respiratory disorders.
- Patient with bleeding disorders.
- Infection at the block injection site.
- Patients with history of allergy to local anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Analgesic Efficacy of Ultrasound Guided Interscalene Block Versus Combined Shoulder Anterior Capsular Block and Suprascapular Nerve Block for Arthroscopic Shoulder Surgeries.
This study will be conducted to compare the perioperative analgesic efficacy of ultrasound - guided interscalene brachial plexus block versus combined shoulder anterior capsular block and anterior suprascapular nerve block for arthroscopic shoulder surgeries.
- Conditions
- Post Operative Pain
- Being tested
- Ultrasound-guided Interscalene Block group, Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block, Bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Interscalene Block groupProcedure or surgery
ultrasound guided interscalene block versus combined ultrasound guided shoulder anterior capsular block and suprascapular nerve block for arthroscopic shoulder surgery
Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve blockProcedure or surgery
Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block
BupivacaineDrug
bupivacaine 0.25%.
| Study group | Role | What they receive |
|---|---|---|
| group 1 Ultrasound-guided Interscalene Block group | Active comparator | In this group, ultrasound-guided ISB will be done using 10 ml of bupivacaine 0.25%. Receives: Procedure: Ultrasound-guided Interscalene Block group; Drug: Bupivacaine |
| group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block | Active comparator | , ultrasound-guided SHAC block will be done using 10 ml of bupivacaine 0.25% injected in the interfacial plane between deltoid and subscapular muscle and 10 ml of bupivacaine 0.25% injected in the pericapsular space. Ultrasound-guided SSN block will be done using 10 ml of bupivacaine 0.25% injected at sub omohyoid space. Receives: Procedure: Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative analgesic consumption
The first 24 hours post operative analgesic consumption
Measured: 24 hours after surgery
Secondary outcomes (3)
Visual Analogue score (VAS) in the first 24 hours after surgery
- Postoperative pain intensity will be assessed in the first 24 hour using VAS score where (0 = no pain and 100 = the worst imaginable pain)
Measured: first 24 hours after surgery
Patient satisfaction score
Patient satisfaction score will be assessed on the basis of a questionnaire and graded on a 4-point scale (excellent/good/fair/poor).
Measured: first 24 hours after surgery
The incidence of hemi diaphragmatic paralysis
hemidiaphragmatic paralysis after block
Measured: immediately before block and immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start23 Jan 2023
- Primary completion11 Aug 2024
- Study completion11 Aug 2024
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosameldin Ibrahim Ibrahim Elsayed Eldib, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686395
- Sponsor's protocol ID
- IRB0010038
- Status last verified
- Dec 2024
- First submitted
- 6 Jan 2023
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Analgesic Efficacy of Ultrasound Guided Interscalene Block Versus Combined Shoulder Anterior Capsular Block and Suprascapular Nerve Block for Arthroscopic Shoulder Surgeries.
- ClinicalTrials.gov ID
- NCT05686395
- Acronym / sponsor ID
- IRB0010038
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 11 Aug 2024 (actual)
- Study completion
- 11 Aug 2024 (actual)
- First posted
- 17 Jan 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.
This study will be conducted to compare the perioperative analgesic efficacy of ultrasound - guided interscalene brachial plexus block versus combined shoulder anterior capsular block and anterior suprascapular nerve block for arthroscopic shoulder surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 Ultrasound-guided Interscalene Block group | Active comparator | Procedure: Ultrasound-guided Interscalene Block group, Drug: BupivacaineIn this group, ultrasound-guided ISB will be done using 10 ml of bupivacaine 0.25%. |
| group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block | Active comparator | Procedure: Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block, Drug: Bupivacaine, ultrasound-guided SHAC block will be done using 10 ml of bupivacaine 0.25% injected in the interfacial plane between deltoid and subscapular muscle and 10 ml of bupivacaine 0.25% injected in the pericapsular space. Ultrasound-guided SSN block will be done using 10 ml of bupivacaine 0.25% injected at sub omohyoid space. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 20-65 years of both sexes, with American Society of Anesthesiologists (ASA) physical status I or II admitted for arthroscopic shoulder surgery.
Key exclusion criteria (7 listed)
- Patient refusal.
- Uncooperative patient.
- Patient with neurological deficit.
- Patients with respiratory disorders.
- Patient with bleeding disorders.
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 |
|---|---|---|
| Ultrasound-guided Interscalene Block groupultrasound guided interscalene block versus combined ultrasound guided shoulder anterior capsular block and suprascapular nerve block for arthroscopic shoulder surgery | Procedure or surgery | group 1 Ultrasound-guided Interscalene Block group |
| Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve blockCombined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block | Procedure or surgery | group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block |
| Bupivacainebupivacaine 0.25%. | Drug | group 1 Ultrasound-guided Interscalene Block group, group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block |
Primary outcome
post operative analgesic consumption
Time frame: 24 hours after surgery
The first 24 hours post operative analgesic consumption
3 secondary outcomes
Visual Analogue score (VAS) in the first 24 hours after surgery
Time frame: first 24 hours after surgery
Patient satisfaction score
Time frame: first 24 hours after surgery
The incidence of hemi diaphragmatic paralysis
Time frame: immediately before block and immediately after procedure
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 19 Dec 2024.
- 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.
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 Ultrasound-guided Interscalene Block group, Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block and Bupivacaine in people with Post Operative Pain, run by Tanta 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 1 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 19 Dec 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 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?
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?
post operative analgesic consumption (time frame: 24 hours after surgery). 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 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.