Interscalene BlockNCT05646667
Interscalene Block Alone Versus Interscalene Block With Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia
A study testing interscalene with Erector spinae plane block group and Interscalene group 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 interscalene brachial plexus block alone versus interscalene brachial plexus block +Erector spinae plane block in anesthesia for shoulder arthroscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interscalene Block, Erector Spinae Plane Block, Shoulder Arthroscopy Anesthesia
- What is being tested?
- interscalene with Erector spinae plane block group and Interscalene group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 15 Feb 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- Both genders,
- BMI < 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.
About this study
Official title: Interscalene Block Alone Versus Interscalene Block With Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia: A Randomized Controlled Trial
The aim of this study is to compare the effectiveness of interscalene brachial plexus block alone versus interscalene brachial plexus block +Erector spinae plane block 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 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.
- Conditions
- Interscalene Block, Erector Spinae Plane Block, Shoulder Arthroscopy Anesthesia, Randomized Controlled Trial
- Being tested
- interscalene with Erector spinae plane block group, Interscalene group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interscalene with Erector spinae plane block groupOther
patients will receive interscalene brachial plexus block using 10 ml of bupivacaine 0.5% and US guided Erector spinae plane block at T2 using 10 ml of bupivacaine 0.5%.
Interscalene groupOther
patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5%.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene with erector spinae plane block group | Experimental | Patients will receive interscalene brachial plexus block using 10 ml of bupivacaine 0.5% and ultrasound guided erector spinae plane block at thoracic (T2) using 10 ml of bupivacaine 0.5%. Receives: Other: interscalene with Erector spinae plane block group |
| Interscalene group | Experimental | Patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5%. Receives: Other: Interscalene group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative fentanyl consumption
If the patient complains of pain during surgery, fentanyl will be administered 1 µg/kg IV increments.
Measured: Intraoperative up to 4 hours
Secondary outcomes (3)
Amount of 24hrs postoperative rescue analgesic consumption
Intravenous meperidine (0.5 mg/kg) will be administered if numerical pain rating scale (NRS) score of more than 3.
Measured: 24 hours postoperatively
Degree of pain by Numerical pain rating scale
Postoperative pain (using NRS at admission) will be measured at PACU, 1h, 2hr. 4hr, 6hr, 8hr, 12hr, 18hr, and 24hrs postoperative. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 24 hours postoperatively
Time to first request of rescue analgesia.
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 postoperatively
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 Feb 2024
- Study completion15 Feb 2024
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Morsy, Tanta University
- Investigators
- Islam Morsy, MD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646667
- Sponsor's protocol ID
- 35915/10/22
- Status last verified
- Mar 2024
- First submitted
- 4 Dec 2022
- Last updated
- 26 Mar 2024
- 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 principle investigator.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interscalene Block Alone Versus Interscalene Block With Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05646667
- Acronym / sponsor ID
- 35915/10/22
- Conditions
- Interscalene Block, Erector Spinae Plane Block, Shoulder Arthroscopy Anesthesia, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- 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 interscalene brachial plexus block alone versus interscalene brachial plexus block +Erector spinae plane block 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene with erector spinae plane block group | Experimental | Other: interscalene with Erector spinae plane block groupPatients will receive interscalene brachial plexus block using 10 ml of bupivacaine 0.5% and ultrasound guided erector spinae plane block at thoracic (T2) using 10 ml of bupivacaine 0.5%. |
| Interscalene group | Experimental | Other: Interscalene groupPatients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-65 years
- Both genders,
- BMI < 40 kg/m2
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective shoulder arthroscopy.
Key exclusion criteria (4 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 |
|---|---|---|
| interscalene with Erector spinae plane block grouppatients will receive interscalene brachial plexus block using 10 ml of bupivacaine 0.5% and US guided Erector spinae plane block at T2 using 10 ml of bupivacaine 0.5%. | Other | Interscalene with erector spinae plane block group |
| Interscalene grouppatients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5%. | Other | Interscalene group |
Primary outcome
Intraoperative fentanyl consumption
Time frame: Intraoperative up to 4 hours
If the patient complains of pain during surgery, fentanyl will be administered 1 µg/kg IV increments.
3 secondary outcomes
Amount of 24hrs postoperative rescue analgesic consumption
Time frame: 24 hours postoperatively
Degree of pain by Numerical pain rating scale
Time frame: 24 hours postoperatively
Time to first request of rescue analgesia.
Time frame: 24 hours postoperatively
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 26 Mar 2024.
- Individual participant dataSharing planned: Yes. the data will be available upon reasonable request from the principle investigator.
Related trials for Interscalene Block
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
RecruitingPhase 4
Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement
Total Shoulder Arthroplasty
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
Not yet recruiting
Combined Suprascapular and PECS I Blocks Versus Interscalene Block for Shoulder Arthroscopy
Postoperative Pain, Hemidiaphragmatic Paresis
RecruitingPhase 4
Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery
Pain, Postoperative, Rebound Pain
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.
Islam Morsy, MD principal investigator
Tanta 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 interscalene with Erector spinae plane block group and Interscalene group 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 5 inclusion and 4 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 26 Mar 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?
Intraoperative fentanyl consumption (time frame: Intraoperative up to 4 hours). 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 26 Mar 2024.