AnalgesiaNCT05381389
Onset and Recovery of Ultrasound Guided Out-of-plane Versus In-plane Interscalene Block in Arthroscopic Shoulder Surgery
A study testing Bupivacaine Hydrochloride in-plane approach for the interscalene block and Bupivacaine Hydrochloride out of-plane approach for the interscalene block in people with Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study was to assess the out-of-plane versus the in-plane approaches for the interscalene brachial plexus block; as regards the performance time, the onset, the progression and the recovery of sensory block, the onset and progression of the motor block as well as, the postoperative pain score and the… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Bupivacaine Hydrochloride in-plane approach for the interscalene block and Bupivacaine Hydrochloride out of-plane approach for the interscalene block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 1 Jun 2019
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I - II
- scheduled to undergo arthroscopic shoulder surgery in the lateral position
Who cannot join
- body mass index ≥ 35 kg/m2 body surface area
- anticipated difficult airway
- infection at the injection site
- known LA allergy,
- contralateral phrenic nerve dysfunction
- history of cardiac disease
Show all 11Show fewer
- history of hepatic disease
- history of renal disease
- coagulopathy
- chronic obstructive pulmonary disease
- neuropathy involving the brachial plexus.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to assess the out-of-plane versus the in-plane approaches for the interscalene brachial plexus block; as regards the performance time, the onset, the progression and the recovery of sensory block, the onset and progression of the motor block as well as, the postoperative pain score and the duration of analgesia for arthroscopic shoulder surgery. A total of 60 patients of American Society of Anesthesiologists (ASA) physical status I-II were randomly divided to receive either the in-plane approach (Group I), or the out-of-plane approach (Group O).
Read the detailed description
60 patients of ASA physical status I - II, greater than or equal to 30 years old and smaller than or equal to 60 years old, scheduled to undergo arthroscopic shoulder surgery in the lateral position; under ultrasound -guided interscalene brachial plexus block (ISPB) in this randomized study at Ain-Shams University Hospitals. On arriving to the operating theater, patients had an 18G intravenous cannula inserted in the non-operative upper limb side. All patients received; 0.05 mg/kg IV midazolam hydrochloride and 30 mg pethidine. Intraoperative basic monitors were applied using 5-leads ECG, pulse oximetry, non-invasive blood pressure (NIBP) and capnography (sample tube inserted under the O2 mask).A simple O2 mask at a flow of 6L/min was applied. Infusion of Ringer's solution was then started at a rate of 5mL/kg/h throughout the surgery. Patients were placed in the supine position with their heads rotated towards the non-operative side. Iodine solution was used as an antiseptic on the operative neck side and then the patient head, neck and chest were draped. Local infiltration of the skin at the point of needle insertion was carried out with 2 ml lidocaine hydrochloride 1%, then a sterile 50-mm 22-G insulated needle was used for performance of the block.The ultrasound with a high frequency linear transducer was used, with the depth setting of 2-4 cm. Distal to proximal (Trace back) approach was used; the supraclavicular fossa was scanned first to identify the subclavian artery as it passes over the first rib; by placing the probe against the clavicle and scanning in a caudate direction. The brachial plexus was easily identified as bunch of grapes supero-lateral to the artery. The plexus was followed medially and cephalad along its course by keeping the nerves in the center of the screen, to identify the brachial plexus roots between the anterior and the middle scalene muscles at the level of the sixth cervical vertebra deep to the sternocleidomastoid muscle.
Patients were then divided into 2 equal groups of 30 patients each:
Group I: An in-plane approach was used for the interscalene block. The needle was brought in the same plane as the probe at a shallow angle to the skin, some distance away from the edge of the probe in a lateral to medial direction so that the whole length of the needle can be visualized. After negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 5 ml increment below the lower root, between the 3 roots and above the upper root.
Group O: An out-of-plane approach was used for the interscalene block. The needle was inserted cranial to the probe and after negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 10 ml increment; lateral and medial to the nerve roots. The needle appeared as a bright dot on the screen and by tilting the probe, the tip was identified as the point where further tilting leads to no longer visualization of the bright dot on the screen.
After completion of the LA administration, the time was recorded as a baseline for the time interval. The assistant who recorded the data was blind to the patient groups. The sensory block was assessed by a pin-prick test using a 3-point scale. The motor block was assessed according to the shoulder, arm and fingers movement using a 3-point scale. Postoperative pain was measured at rest using the VAS score
- Conditions
- Analgesia
- Being tested
- Bupivacaine Hydrochloride in-plane approach for the interscalene block, Bupivacaine Hydrochloride out of-plane approach for the interscalene block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Hydrochloride in-plane approach for the interscalene blockDrug
20 ml of 0.5% bupivacaine added to them 50 μg adrenaline in a concentration of 1:400,000, were prepared by an assistant immediately before administration and injected in an in-plane approach to the brachial plexues
Bupivacaine Hydrochloride out of-plane approach for the interscalene blockDrug
20 ml of 0.5% bupivacaine added to them 50 μg adrenaline in a concentration of 1:400,000, were prepared by an assistant immediately before administration and injected in an out of-plane approach to the brachial plexues
| Study group | Role | What they receive |
|---|---|---|
| Group In-plane approach: | Active comparator | An in-plane approach was used for the interscalene block. The needle was brought in the same plane as the probe at a shallow angle to the skin, some distance away from the edge of the probe in a lateral to medial direction so that the whole length of the needle can be visualized. After negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 5 ml increment below the lower root, between the 3 roots and above the upper root. Receives: Drug: Bupivacaine Hydrochloride in-plane approach for the interscalene block |
| Group Out-of-plane approach | Active comparator | An out-of-plane approach was used for the interscalene block. The needle was inserted cranial to the probe and after negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 10 ml increment; lateral and medial to the nerve roots. The needle appeared as a bright dot on the screen and by tilting the probe, the tip was identified as the point where further tilting leads to no longer visualization of the bright dot on the screen. Receives: Drug: Bupivacaine Hydrochloride out of-plane approach for the interscalene block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The onset of sensory block (time to C5 block)
defined as the period between the completion of the LA administration and the loss of sensation to pin prick in C5 dermatome performed every 1 minute
Measured: 30 minutes
Secondary outcomes (7)
The procedure time
time from the skin infiltration by the lidocaine till removal of the stimulating needle from the skin
Measured: 20 minutes
Progression of sensory block
performed by pin prick every 5 minutes in C6, C7, C8 and T1 dermatomes
Measured: over the first 20 minutes of LA injection
The onset of motor block
the period between the completion of LA administration till lack of movement of the shoulder, arm and fingers muscles assessed every 1 minute.
Measured: 30 minutes
The progression of motor block
in the shoulder, arm and fingers muscles assessed every 5 minutes
Measured: over the first 20 minutes of LA injection
The duration of motor block
the period between the onset of motor block till complete recovery of motor function
Measured: 24 hours
Postoperative pain score
Intensity of pain was monitored at rest
Measured: 24 hours
The duration of analgesia
the time interval between the onset of sensory block until the first call for analgesia
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Dec 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada M.Samir, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381389
- Sponsor's protocol ID
- FMASU R59/2018
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 19 May 2022
- Results posted
- 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 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset and Recovery of Ultrasound Guided Out-of-plane Versus In-plane Interscalene Block in Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT05381389
- Acronym / sponsor ID
- FMASU R59/2018
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 19 May 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 was to assess the out-of-plane versus the in-plane approaches for the interscalene brachial plexus block; as regards the performance time, the onset, the progression and the recovery of sensory block, the onset and progression of the motor block as well as, the postoperative pain score and the duration of analgesia for arthroscopic shoulder surgery. A total of 60 patients of American Society of Anesthesiologists (ASA) physical status I-II were randomly divided to receive either the in-plane approach (Group I), or the out-of-plane approach (Group O).
Detailed description
60 patients of ASA physical status I - II, greater than or equal to 30 years old and smaller than or equal to 60 years old, scheduled to undergo arthroscopic shoulder surgery in the lateral position; under ultrasound -guided interscalene brachial plexus block (ISPB) in this randomized study at Ain-Shams University Hospitals. On arriving to the operating theater, patients had an 18G intravenous cannula inserted in the non-operative upper limb side. All patients received; 0.05 mg/kg IV midazolam hydrochloride and 30 mg pethidine. Intraoperative basic monitors were applied using 5-leads ECG, pulse oximetry, non-invasive blood pressure (NIBP) and capnography (sample tube inserted under the O2 mask).A simple O2 mask at a flow of 6L/min was applied. Infusion of Ringer's solution was then started at a rate of 5mL/kg/h throughout the surgery. Patients were placed in the supine position with their heads rotated towards the non-operative side. Iodine solution was used as an antiseptic on the operative neck side and then the patient head, neck and chest were draped. Local infiltration of the skin at the point of needle insertion was carried out with 2 ml lidocaine hydrochloride 1%, then a sterile 50-mm 22-G insulated needle was used for performance of the block.The ultrasound with a high frequency linear transducer was used, with the depth setting of 2-4 cm. Distal to proximal (Trace back) approach was used; the supraclavicular fossa was scanned first to identify the subclavian artery as it passes over the first rib; by placing the probe against the clavicle and scanning in a caudate direction. The brachial plexus was easily identified as bunch of grapes supero-lateral to the artery. The plexus was followed medially and cephalad along its course by keeping the nerves in the center of the screen, to identify the brachial plexus roots between the anterior and the middle scalene muscles at the level of the sixth cervical vertebra deep to the sternocleidomastoid muscle.
Patients were then divided into 2 equal groups of 30 patients each:
Group I: An in-plane approach was used for the interscalene block. The needle was brought in the same plane as the probe at a shallow angle to the skin, some distance away from the edge of the probe in a lateral to medial direction so that the whole length of the needle can be visualized. After negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 5 ml increment below the lower root, between the 3 roots and above the upper root.
Group O: An out-of-plane approach was used for the interscalene block. The needle was inserted cranial to the probe and after negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 10 ml increment; lateral and medial to the nerve roots. The needle appeared as a bright dot on the screen and by tilting the probe, the tip was identified as the point where further tilting leads to no longer visualization of the bright dot on the screen.
After completion of the LA administration, the time was recorded as a baseline for the time interval. The assistant who recorded the data was blind to the patient groups. The sensory block was assessed by a pin-prick test using a 3-point scale. The motor block was assessed according to the shoulder, arm and fingers movement using a 3-point scale. Postoperative pain was measured at rest using the VAS score
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group In-plane approach: | Active comparator | Drug: Bupivacaine Hydrochloride in-plane approach for the interscalene blockAn in-plane approach was used for the interscalene block. The needle was brought in the same plane as the probe at a shallow angle to the skin, some distance away from the edge of the probe in a lateral to medial direction so that the whole length of the needle can be visualized. After negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 5 ml increment below the lower root, between the 3 roots and above the upper root. |
| Group Out-of-plane approach | Active comparator | Drug: Bupivacaine Hydrochloride out of-plane approach for the interscalene blockAn out-of-plane approach was used for the interscalene block. The needle was inserted cranial to the probe and after negative aspiration and assurance that high resistance to injection was absent, the LA was injected in a 10 ml increment; lateral and medial to the nerve roots. The needle appeared as a bright dot on the screen and by tilting the probe, the tip was identified as the point where further tilting leads to no longer visualization of the bright dot on the screen. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA physical status I - II
- scheduled to undergo arthroscopic shoulder surgery in the lateral position
Key exclusion criteria (11 listed)
- body mass index ≥ 35 kg/m2 body surface area
- anticipated difficult airway
- infection at the injection site
- known LA allergy,
- contralateral phrenic nerve dysfunction
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 |
|---|---|---|
| Bupivacaine Hydrochloride in-plane approach for the interscalene block20 ml of 0.5% bupivacaine added to them 50 μg adrenaline in a concentration of 1:400,000, were prepared by an assistant immediately before administration and injected in an in-plane approach to the brachial plexues | Drug | Group In-plane approach: |
| Bupivacaine Hydrochloride out of-plane approach for the interscalene block20 ml of 0.5% bupivacaine added to them 50 μg adrenaline in a concentration of 1:400,000, were prepared by an assistant immediately before administration and injected in an out of-plane approach to the brachial plexues | Drug | Group Out-of-plane approach |
Primary outcome
The onset of sensory block (time to C5 block)
Time frame: 30 minutes
defined as the period between the completion of the LA administration and the loss of sensation to pin prick in C5 dermatome performed every 1 minute
7 secondary outcomes
The procedure time
Time frame: 20 minutes
Progression of sensory block
Time frame: over the first 20 minutes of LA injection
The onset of motor block
Time frame: 30 minutes
The progression of motor block
Time frame: over the first 20 minutes of LA injection
The duration of motor block
Time frame: 24 hours
Postoperative pain score
Time frame: 24 hours
The duration of analgesia
Time frame: 24 hours
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 May 2022.
- 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 Bupivacaine Hydrochloride in-plane approach for the interscalene block and Bupivacaine Hydrochloride out of-plane approach for the interscalene block in people with Analgesia, 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 2 inclusion and 11 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 May 2022. 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?
The onset of sensory block (time to C5 block) (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 May 2022.