Interscalene BlockNCT05646654
Interscalene Block Versus Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia
A study testing Erector spinae plane block and Interscalene brachial plexus block in people with Interscalene Block and Erector Spinae Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effectiveness of ESPB versus ISB in anesthesia for shoulder arthroscopy Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Interscalene Block, Erector Spinae Plane Block, Arthroscopy
- What is being tested?
- Erector spinae plane block and Interscalene brachial plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 15 May 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Body Mass Index < 40 kg/m2
- American Society of Anesthesiologists (ASA) physical status I-II
- scheduled for elective shoulder arthroscopy
Who cannot join
- Known allergy to local anesthetics
- Allergy to all opioid medications
- Diagnostic shoulder arthroscopic procedures
- Patients with chronic opioids
- Patients who converted to general anesthesia use and coagulopathy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Islam Morsy
Tanta, El-Gharbia, 31527
Islam Morsy, 00201093387374 ext. 139, eslam.morsy@med.tanta.edu.eg
Hussein G Almawardy, MD
About this study
Official title: Interscalene Block Versus Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia: A Randomized Controlled Trial
The aim of this study is to compare the effectiveness of ESPB versus ISB in anesthesia for shoulder arthroscopy
Read the detailed description
Regional anesthetic techniques can control pain effectively, both at rest and on movement, allowing earlier mobilization without the adverse effects of opioids. Among the various types of regional anesthetic techniques, the interscalene brachial plexus block (ISB) is a gold standard used nerve block technique for postoperative analgesia in patients undergoing shoulder surgery, as it has consistently been shown to significantly control.
the interscalene brachial plexus block (ISB) regional anesthesia offers many advantages over general anesthesia for both arthroscopic and open surgeries of the shoulder it provides excellent intraoperative anesthesia and muscle relaxation' as well as analgesia that continues into the postoperative period
- Conditions
- Interscalene Block, Erector Spinae Plane Block, Arthroscopy
- Being tested
- Erector spinae plane block, Interscalene brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
Using a 20-gauge block needle put in-plane in a cephalad-to-caudad orientation to position the tip into the fascial plane on the deep (anterior) side of the erector spinae muscle, 20 ml bupivacaine 0.5% will be injected
Interscalene brachial plexus blockProcedure or surgery
Using a lateral-to-medial approach, the 25-gauge needle will be inserted into the middle scalene muscle, advanced, and placed immediately lateral to the nerve roots. the needle will be visualize using an ultrasound beam to avoid intraneural and intravascular injections. After confirming negative blood aspiration, we will inject 15 mL of 0.5% bupivacaine around the nerve roots
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block group | Active comparator | 3ml lidocaine 2% will be used to anesthetize the skin. Using a 20-gauge block needle put in-plane in a cephalad-to-caudad orientation to position the tip into the fascial plane on the deep (anterior) side of the erector spinae muscle, 20 ml bupivacaine 0.5% will be injected. Receives: Procedure: Erector spinae plane block |
| Interscalene group | Active comparator | Using a lateral-to-medial approach, the 25-gauge needle will be inserted into the middle scalene muscle, advanced, and placed immediately lateral to the nerve roots. the needle will be visualize using an ultrasound beam to avoid intraneural and intravascular injections. After confirming negative blood aspiration, we will inject 15 mL of 0.5% bupivacaine around the nerve roots Receives: Procedure: Interscalene brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative fentanyl consumption
Fntanyl will be administered 1 µg/kg IV increments.
Measured: 30 minutes
Secondary outcomes (3)
Postoperative pain
numeric rating scale (NRS) (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 24 hours postoperative
Rescue analgesia in the form of IV meperidine (0.5 mg/kg) boluses if NRS >3. Time to the 1st rescue analgesic request will be recorded
Measured: 24 hours postoperative
Total amount of rescue analgesic
Rescue analgesia in the form of IV meperidine (0.5 mg/kg) boluses if NRS >3.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start15 Dec 2022
- Primary completion15 May 2023 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interscalene BlockStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Morsy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646654
- Sponsor's protocol ID
- 35914/10/22
- Status last verified
- Apr 2023
- First submitted
- 4 Dec 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interscalene Block Versus Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05646654
- Acronym / sponsor ID
- 35914/10/22
- Conditions
- Interscalene Block, Erector Spinae Plane Block, Arthroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 12 Dec 2022 (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 aim of this study is to compare the effectiveness of ESPB versus ISB in anesthesia for shoulder arthroscopy
Detailed description
Regional anesthetic techniques can control pain effectively, both at rest and on movement, allowing earlier mobilization without the adverse effects of opioids. Among the various types of regional anesthetic techniques, the interscalene brachial plexus block (ISB) is a gold standard used nerve block technique for postoperative analgesia in patients undergoing shoulder surgery, as it has consistently been shown to significantly control.
the interscalene brachial plexus block (ISB) regional anesthesia offers many advantages over general anesthesia for both arthroscopic and open surgeries of the shoulder it provides excellent intraoperative anesthesia and muscle relaxation' as well as analgesia that continues into the postoperative period
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block group | Active comparator | Procedure: Erector spinae plane block3ml lidocaine 2% will be used to anesthetize the skin. Using a 20-gauge block needle put in-plane in a cephalad-to-caudad orientation to position the tip into the fascial plane on the deep (anterior) side of the erector spinae muscle, 20 ml bupivacaine 0.5% will be injected. |
| Interscalene group | Active comparator | Procedure: Interscalene brachial plexus blockUsing a lateral-to-medial approach, the 25-gauge needle will be inserted into the middle scalene muscle, advanced, and placed immediately lateral to the nerve roots. the needle will be visualize using an ultrasound beam to avoid intraneural and intravascular injections. After confirming negative blood aspiration, we will inject 15 mL of 0.5% bupivacaine around the nerve roots |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Body Mass Index < 40 kg/m2
- American Society of Anesthesiologists (ASA) physical status I-II
- scheduled for elective shoulder arthroscopy
Key exclusion criteria (5 listed)
- Known allergy to local anesthetics
- Allergy to all opioid medications
- Diagnostic shoulder arthroscopic procedures
- Patients with chronic opioids
- Patients who converted to general anesthesia use and coagulopathy
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 |
|---|---|---|
| Erector spinae plane blockUsing a 20-gauge block needle put in-plane in a cephalad-to-caudad orientation to position the tip into the fascial plane on the deep (anterior) side of the erector spinae muscle, 20 ml bupivacaine 0.5% will be injected | Procedure or surgery | Erector spinae plane block group |
| Interscalene brachial plexus blockUsing a lateral-to-medial approach, the 25-gauge needle will be inserted into the middle scalene muscle, advanced, and placed immediately lateral to the nerve roots. the needle will be visualize using an ultrasound beam to avoid intraneural and intravascular injections. After confirming negative blood aspiration, we will inject 15 mL of 0.5% bupivacaine around the nerve roots | Procedure or surgery | Interscalene group |
Primary outcome
Intraoperative fentanyl consumption
Time frame: 30 minutes
Fntanyl will be administered 1 µg/kg IV increments.
3 secondary outcomes
Postoperative pain
Time frame: 24 hours postoperative
Rescue analgesia in the form of IV meperidine (0.5 mg/kg) boluses if NRS >3. Time to the 1st rescue analgesic request will be recorded
Time frame: 24 hours postoperative
Total amount of rescue analgesic
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the principal investigator
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block and Interscalene brachial plexus block in people with Interscalene Block and Erector Spinae Plane Block, 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 3 inclusion and 5 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 Apr 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 Islam Morsy, MD (00201093387374 ext. 139, eslam.morsy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative fentanyl consumption (time frame: 30 minutes). 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 Apr 2023.