ArthroscopyNCT05222334
Ultrasound-Guided Extrafascial Versus Intrafascial Interscalene Brachial Plexus Block in Shoulder Arthroscopy
A study testing Intrafascial interscalene brachial plexus block, Extrafascial interscalene brachial plexus block group and Bupivacaine in people with Arthroscopy and Analgesia, run by Tanta University.
Trial summary
The aim of the study is to compare the diaphragmatic excursion and postoperative analgesia in the extrafascial versus intrafascial Interscalene brachial plexus block in patients undergoing shoulder arthroscopy. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Arthroscopy, Analgesia, Intrafascial Interscalene Brachial Plexus Block
- What is being tested?
- Intrafascial interscalene brachial plexus block, Extrafascial interscalene brachial plexus block group and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 1 Feb 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients of both sexes aged (21-60years) with American Society of Anesthesiologists (ASA) physical status I/II scheduled for shoulder arthroscopy
Who cannot join
- Patient refusal.
- Pre-existing (obstructive or restrictive) pulmonary disease.
- Bleeding disorders (coagulopathy).
- Mental dysfunction.
- History of allergy to local anesthetics.
- Pregnancy
- Body mass index (BMI) >40
About this study
Official title: Perioperative Respiratory and Analgesic Effects of Ultrasound-Guided Extrafascial Versus Intrafascial Interscalene Brachial Plexus Block in Patients Undergoing Shoulder Arthroscopy
The aim of the study is to compare the diaphragmatic excursion and postoperative analgesia in the extrafascial versus intrafascial Interscalene brachial plexus block in patients undergoing shoulder arthroscopy.
- Being tested
- Intrafascial interscalene brachial plexus block, Extrafascial interscalene brachial plexus block group, Bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrafascial interscalene brachial plexus blockProcedure or surgery
After sterilization of skin with povidone-iodine (betadine) and skin infiltration with 1-3ml lidocaine 1%, interscalene brachial plexus block will be performed using an ultrasound machine (Phillips Cx-50,Amsterdam, Netherlands) with a linear probe (L12-3 MHz) will be used in both groups. The US transducer will be placed under aseptic fashion on the lateral side of the neck at the cricoid cartilage level to view three hypoechoic structures, that represent the roots of the brachial plexus.
The two outermost nerve roots (C5 and C6) between the anterior and the middle scalene muscles will be identified and the local anesthetic (10 ml 0.5% bupivacaine) is then injected, so that spread will be seen immediately between the C5 and the C6 nerve roots.
Extrafascial interscalene brachial plexus block groupProcedure or surgery
Final needle tip position will be 4 mm lateral to the brachial plexus sheath, at a level equidistant between C5 and C6 roots. The distance of 4 mm is chosen according to the calculated success rate over 90% reported. the local anesthetic (10 ml 0.5% bupivacaine) is then injected
BupivacaineDrug
bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Intrafascial interscalene brachial plexus block group | Experimental | The patients will receive 10 ml of 0.5% bupivacaine for intrafascial interscalene brachial plexus block group Receives: Procedure: Intrafascial interscalene brachial plexus block; Drug: Bupivacaine |
| Extrafascial interscalene brachial plexus block group | Experimental | The patients will receive 10 ml of 0.5% bupivacaine for extrafascial interscalene brachial plexus block group Receives: Procedure: Extrafascial interscalene brachial plexus block group; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diaphragmatic excursion reduction after interscalene block
The diaphragmatic excursion will be measured before the procedure (pre-block), 30 min after the block, and postoperative in Post-Anesthesia Care Unit. Hemidiaphragmatic paresis is defined as hemi-diaphragmatic excursion reduction superior to 75% compared with the pre-procedure value.
Measured: 30 min postoperative.
Secondary outcomes (6)
Efficacy of block (sensory)
The sensory block is assessed by pinprick on a score ranging from 2 to 0 scored as full sensation =2, decreased sensation =1, and loss of sensation to touch or pinprick=0. A successful block is defined as complete sensory (score= 0) in the distribution of the C5 and C6 nerve roots within 30 min of performing the Interscalene Brachial Plexus Block.
Measured: 30 minutes Postoperatively
Forced expiratory volume in 1 second (FEV 1)
Respiratory related outcome: pulmonary function test including forced expiratory volume in 1 second (FEV 1) will be assessed before block and 30 minutes after discharge to Post-Anesthesia Care Unit (PACU) with a laboratory spirometer (Carevusion Germany Spirometer; Master screen PFT). The best value will be measured and recorded
Measured: Intraoperatively or 30 minutes postoperatively
Pain score using numerical rating scale (NRS)
Numerical rating scale (NRS) for assessment of pain intensity (0 = no pain) to (10 = intolerable pain), pain relief is defined as a numerical rating scale of 3 or lower. If the score is >3, the patient will need analgesia in the form of morphine 0.05 mg/kg till it decreases to ≤3. numerical rating scale will be assessed and recorded on arrival to Post-Anesthesia Care Unit (PACU), 1, 2, 4, 8, 12, and 24 hr postoperatively by an anesthesiologist who is blinded to the study groups
Measured: 24 hours Postoperative
Total postoperative analgesic consumption
Total consumption of rescue analgesia in form of morphine 0.05 mg/kg/ dose will be recorded
Measured: 24 hours Postoperative
Peak expiratory flow (PEF)
Peak expiratory flow (PEF) will be assessed before block and 30 minutes after discharge to Post-Anesthesia Care Unit (PACU) with a laboratory spirometer (Carevusion Germany Spirometer; Master screen PFT). The best value will be measured and recorded
Measured: Intraoperatively or 30 minutes postoperatively
Efficacy of block (Motor)
Motor assessment will be tested by using arm abduction (C5), and forearm flexion (C6) (incapacity to overcome gravity= 0; reduced force compared with contralateral arm =1, no loss of force =2). A successful block is defined as motor (score,=0) block in the distribution of the C5 and C6 nerve roots within 30 min of performing the Interscalene Brachial Plexus Block.
Measured: 30 minutes Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroscopyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Emad Eissa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222334
- Sponsor's protocol ID
- 33802/4/20
- Status last verified
- Jan 2022
- First submitted
- 24 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon any reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Respiratory and Analgesic Effects of Ultrasound-Guided Extrafascial Versus Intrafascial Interscalene Brachial Plexus Block in Patients Undergoing Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT05222334
- Acronym / sponsor ID
- 33802/4/20
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 3 Feb 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 the study is to compare the diaphragmatic excursion and postoperative analgesia in the extrafascial versus intrafascial Interscalene brachial plexus block in patients undergoing shoulder arthroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrafascial interscalene brachial plexus block group | Experimental | Procedure: Intrafascial interscalene brachial plexus block, Drug: BupivacaineThe patients will receive 10 ml of 0.5% bupivacaine for intrafascial interscalene brachial plexus block group |
| Extrafascial interscalene brachial plexus block group | Experimental | Procedure: Extrafascial interscalene brachial plexus block group, Drug: BupivacaineThe patients will receive 10 ml of 0.5% bupivacaine for extrafascial interscalene brachial plexus block group |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients of both sexes aged (21-60years) with American Society of Anesthesiologists (ASA) physical status I/II scheduled for shoulder arthroscopy
Key exclusion criteria (7 listed)
- Patient refusal.
- Pre-existing (obstructive or restrictive) pulmonary disease.
- Bleeding disorders (coagulopathy).
- Mental dysfunction.
- History of allergy to local anesthetics.
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 |
|---|---|---|
| Intrafascial interscalene brachial plexus blockAfter sterilization of skin with povidone-iodine (betadine) and skin infiltration with 1-3ml lidocaine 1%, interscalene brachial plexus block will be performed using an ultrasound machine (Phillips Cx-50,Amsterdam, Netherlands) with a linear probe (L12-3 MHz) will be used in both groups. The US transducer will be placed under aseptic fashion on the lateral side of the neck at the cricoid cartilage level to view three hypoechoic structures, that represent the roots of the brachial plexus. The two outermost nerve roots (C5 and C6) between the anterior and the middle scalene muscles will be identified and the local anesthetic (10 ml 0.5% bupivacaine) is then injected, so that spread will be seen immediately between the C5 and the C6 nerve roots. | Procedure or surgery | Intrafascial interscalene brachial plexus block group |
| Extrafascial interscalene brachial plexus block groupFinal needle tip position will be 4 mm lateral to the brachial plexus sheath, at a level equidistant between C5 and C6 roots. The distance of 4 mm is chosen according to the calculated success rate over 90% reported. the local anesthetic (10 ml 0.5% bupivacaine) is then injected | Procedure or surgery | Extrafascial interscalene brachial plexus block group |
| Bupivacainebupivacaine | Drug | Extrafascial interscalene brachial plexus block group, Intrafascial interscalene brachial plexus block group |
Primary outcome
Incidence of diaphragmatic excursion reduction after interscalene block
Time frame: 30 min postoperative.
The diaphragmatic excursion will be measured before the procedure (pre-block), 30 min after the block, and postoperative in Post-Anesthesia Care Unit. Hemidiaphragmatic paresis is defined as hemi-diaphragmatic excursion reduction superior to 75% compared with the pre-procedure value.
6 secondary outcomes
Efficacy of block (sensory)
Time frame: 30 minutes Postoperatively
Forced expiratory volume in 1 second (FEV 1)
Time frame: Intraoperatively or 30 minutes postoperatively
Pain score using numerical rating scale (NRS)
Time frame: 24 hours Postoperative
Total postoperative analgesic consumption
Time frame: 24 hours Postoperative
Peak expiratory flow (PEF)
Time frame: Intraoperatively or 30 minutes postoperatively
Efficacy of block (Motor)
Time frame: 30 minutes Postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: Yes. The data will be available upon any reasonable request
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intrafascial interscalene brachial plexus block, Extrafascial interscalene brachial plexus block group and Bupivacaine in people with Arthroscopy and Analgesia, run by Tanta University.
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: status not confirmed, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Incidence of diaphragmatic excursion reduction after interscalene block (time frame: 30 min postoperative.). 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 3 Feb 2022.