Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder SurgeriesNCT05978427
Efficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
A study testing interscalene block and superior trunk block in people with Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries, run by Ain Shams University at 1 site in Egypt.
Trial summary
Efficacy and safety of superior trunk block versus interscalene block for post-operative analgesia in shoulder surgeries Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
- What is being tested?
- interscalene block and superior trunk block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients American Society of Anaesthesiologists physical status (ASA) is I to II.
- Both genders.
- Aged group from 21 to 50 years old.
- Patients electively scheduled for shoulder surgery under general anesthesia with normal coagulation profile.
Who cannot join
- Refusal of the procedure or participation in the study.
- Any history or evidence of coagulopathy.
- Evidence of infection at injection site.
- Allergy to study drugs.
- Patients with pulmonary severe respiratory disease.
- Herniated cervical disc or cervical myelopathy.
- Pre-existing neuropathy of the operative limb
Trial locations and contacts
1 site in 1 country.
About this study
Efficacy and safety of superior trunk block versus interscalene block for post-operative analgesia in shoulder surgeries
Read the detailed description
The interscalene brachial plexus block is the gold standard analgesic technique for surgery involving the shoulder and upper arm. However, due to its complications as hemidiaphragmatic paralysis, the superior trunk block was developed in an attempt to reduce major complications.The utility of the superior trunk block has yet to be studied in shoulder surgeries.
- Conditions
- Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
- Being tested
- interscalene block, superior trunk block
- Keywords
- superior trunk block, interscalene block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interscalene blockProcedure or surgery
will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in interscalene block.
superior trunk blockProcedure or surgery
will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in superior trunk block.
| Study group | Role | What they receive |
|---|---|---|
| interscalene block group | Active comparator | participants undergoing shoulder surgeries will receive ultrasound guided interscalene block Receives: Procedure: interscalene block; Procedure: superior trunk block |
| superior trunk block group | Active comparator | participants undergoing shoulder surgeries will receive ultrasound guided superior trunk block Receives: Procedure: interscalene block; Procedure: superior trunk block |
What is being measured
The primary outcome is the main question the study is designed to answer.
diaphragmatic paralysis postoperative
- The incidence of diaphragmatic paralysis postoperative assessed by Diaphragmatic excursion distance by Ultrasound
Measured: within 24 hours after surgery
Secondary outcomes (3)
analgesic efficacy
- Analgesic efficacy of the nerve block in both groups by assessing postoperative pain vas score
Measured: within 24 hours after surgery
rescue analgesia
The total amount of rescue analgesia used
Measured: within 24 hours after surgery
Post operative nausea and vomiting
incidence of post operative complications as nausea an vomiting
Measured: within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 May 2023
- Primary completion1 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder SurgeriesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978427
- Sponsor's protocol ID
- superior trunk vs interscalene
- Status last verified
- May 2023
- First submitted
- 30 Jul 2023
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
- ClinicalTrials.gov ID
- NCT05978427
- Acronym / sponsor ID
- superior trunk vs interscalene
- Conditions
- Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
- Keywords
- superior trunk block, interscalene block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 7 Aug 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.
Efficacy and safety of superior trunk block versus interscalene block for post-operative analgesia in shoulder surgeries
Detailed description
The interscalene brachial plexus block is the gold standard analgesic technique for surgery involving the shoulder and upper arm. However, due to its complications as hemidiaphragmatic paralysis, the superior trunk block was developed in an attempt to reduce major complications.The utility of the superior trunk block has yet to be studied in shoulder surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interscalene block group | Active comparator | Procedure: interscalene block, Procedure: superior trunk blockparticipants undergoing shoulder surgeries will receive ultrasound guided interscalene block |
| superior trunk block group | Active comparator | Procedure: interscalene block, Procedure: superior trunk blockparticipants undergoing shoulder surgeries will receive ultrasound guided superior trunk block |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients American Society of Anaesthesiologists physical status (ASA) is I to II.
- Both genders.
- Aged group from 21 to 50 years old.
- Patients electively scheduled for shoulder surgery under general anesthesia with normal coagulation profile.
Key exclusion criteria (7 listed)
- Refusal of the procedure or participation in the study.
- Any history or evidence of coagulopathy.
- Evidence of infection at injection site.
- Allergy to study drugs.
- Patients with pulmonary severe respiratory disease.
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 |
|---|---|---|
| interscalene blockwill receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in interscalene block. | Procedure or surgery | interscalene block group, superior trunk block group |
| superior trunk blockwill receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in superior trunk block. | Procedure or surgery | interscalene block group, superior trunk block group |
Primary outcome
diaphragmatic paralysis postoperative
Time frame: within 24 hours after surgery
o The incidence of diaphragmatic paralysis postoperative assessed by Diaphragmatic excursion distance by Ultrasound
3 secondary outcomes
analgesic efficacy
Time frame: within 24 hours after surgery
rescue analgesia
Time frame: within 24 hours after surgery
Post operative nausea and vomiting
Time frame: within 24 hours after surgery
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 28 Jun 2024.
- Individual participant dataSharing planned: Undecided
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 interscalene block and superior trunk block in people with Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries, run by Ain Shams 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 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 28 Jun 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?
diaphragmatic paralysis postoperative (time frame: within 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 28 Jun 2024.