Phrenic ParalysisNCT06640621
The Effect of Brachial Plexus Block on Diaphragm Movement
A study testing Different concentration of ropivacaine for single brachial plexus block in people with Phrenic Paralysis and Shoulder Joint Surgery, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of this study is to quickly evaluate the degree of phrenic nerve block by observing the changes of diaphragm movement through ultrasound, and to find the best scheme for clinical application by controlling the concentration of narcotic drugs, so as to reduce respiratory related complications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phrenic Paralysis, Shoulder Joint Surgery, Rotator Cuff Injury
- What is being tested?
- Different concentration of ropivacaine for single brachial plexus block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2022to 7 Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- operation type: patients undergoing shoulder ligament rupture repair under selective general anesthesia combined with nerve block analgesia
- age: 18 ~ 65
- ASA class I or II
Who cannot join
- patient rejection
- brachial plexus injury
- severe cardiovascular disease
- allergic to the drugs used in the test
- infection at the puncture site
- difficulty in understanding (unable to understand the pain assessment method)
- recent history of opioid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study on the Effect of Brachial Plexus Block with Different Concentrations of Ropivacaine on Diaphragm Movement
The purpose of this study is to quickly evaluate the degree of phrenic nerve block by observing the changes of diaphragm movement through ultrasound, and to find the best scheme for clinical application by controlling the concentration of narcotic drugs, so as to reduce respiratory related complications.
Read the detailed description
40 ASA grade I - II patients were selected from the patients who underwent shoulder ligament rupture repair surgery under selective general anesthesia combined with brachial plexus block analgesia in the sports medical center of our hospital. They were randomly divided into two groups: high concentration group (group I) and low concentration group (Group II), with 20 cases in each group. 40 patients underwent a single brachial plexus block under ultrasound guidance before general anesthesia. In group I, ropivacaine 100mg + normal saline to 20ml (0.5% ropivacaine 20ml), and in group II, ropivacaine 40mg + normal saline to 20ml (0.2% ropivacaine 20ml). The high-frequency ultrasonic probe was located in the intermuscular sulcus, clearly exposing the three trunks of the brachial plexus. Using out of plane technology, the drug solution was injected around the brachial plexus, Ultrasonic images showed that the drug solution evenly wrapped the nerve trunks. The diaphragmatic movement of patients was scanned and recorded before and 30 minutes after block. The dispensing nurse, the operator and the follow-up doctor are independent individuals, and the operator and the follow-up doctor do not know the patient grouping. After confirming the effect of nerve block, the operating doctor will carry out general anesthesia and start the operation. The patients were followed up 6 hours after operation, and NRS scores were made and recorded.
- Being tested
- Different concentration of ropivacaine for single brachial plexus block
- Keywords
- brachial plexus block, diaphragm movement
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different concentration of ropivacaine for single brachial plexus blockDrug
40 ASA grade I - II patients were selected from the patients who underwent shoulder ligament rupture repair surgery under selective general anesthesia combined with brachial plexus block analgesia in the sports medical center of our hospital. They were randomly divided into two groups: high concentration group (group I) and low concentration group (Group II), with 20 cases in each group. 40 patients underwent a single brachial plexus block under ultrasound guidance before general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| group I | Active comparator | In group I(high concentration group), ropivacaine 100mg + normal saline to 20ml (0.5% ropivacaine 20ml) is used for single brachial plexus block under ultrasound guidance before general anesthesia. Receives: Drug: Different concentration of ropivacaine for single brachial plexus block |
| group II | Experimental | In group II (low concentration group), ropivacaine 40mg + normal saline to 20ml (0.2% ropivacaine 20ml) is used for single brachial plexus block under ultrasound guidance before general anesthesia. Receives: Drug: Different concentration of ropivacaine for single brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the maximum range of motion of bilateral diaphragm
Using a low-frequency probe (3-5mhz), place the probe at the bilateral axillary front or at the junction of the clavicular midline and the costal margin respectively, and take the liver and spleen as the sound window, it can be seen that the diaphragm is in an arc-shaped strong echo line. Select the M-mode, and make the sampling line vertical to the diaphragm. Measure the motion amplitude / movement of the diaphragm during calm breathing and maximum deep breathing, and the vertical motion distance (CM) of the diaphragm in the inspiratory phase and expiratory phase respectively.
Measured: The ultrasound examination of bilateral diaphragms was carried out before brachial plexus block on the affected side, and the ultrasound examination of diaphragm on the blocked side was carried out again 10 minutes after local anesthetic
the change rate of diaphragm thickness
Select the M-mode to make the sampling line vertical to the diaphragm, Measure the end inspiratory and end expiratory diaphragm thickness at calm breathing and maximum deep breathing respectively, and calculate the change rate of diaphragm thickness at calm breathing and maximum deep breathing [(end inspiratory diaphragm thickness - end expiratory diaphragm thickness) / end expiratory diaphragm thickness × 100%].
Measured: The ultrasound examination of bilateral diaphragms was carried out before brachial plexus block on the affected side, and the ultrasound examination of diaphragm on the blocked side was carried out again 10 minutes after local anesthetic injection
Secondary outcomes (1)
Pain relief score of patients.
NRS score of patients at 6 hours and 24 hours after operation. The Numeric Rating Scale (NRS) is a tool used to assess pain by asking patients to select a number on a scale of 0 to 10 to indicate their level of pain. 0 is painless, 10 is severe .
Measured: 6 hours and 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start8 Nov 2022
- Primary completion7 Oct 2023
- Study completion7 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phrenic ParalysisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640621
- Sponsor's protocol ID
- M2021684
- Other IDs
- LM2022383
- Status last verified
- Jun 2024
- First submitted
- 1 Nov 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Effect of Brachial Plexus Block with Different Concentrations of Ropivacaine on Diaphragm Movement
- ClinicalTrials.gov ID
- NCT06640621
- Acronym / sponsor ID
- M2021684
- Keywords
- brachial plexus block, diaphragm movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 7 Oct 2023 (actual)
- Study completion
- 7 Oct 2023 (actual)
- First posted
- 15 Oct 2024 (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 purpose of this study is to quickly evaluate the degree of phrenic nerve block by observing the changes of diaphragm movement through ultrasound, and to find the best scheme for clinical application by controlling the concentration of narcotic drugs, so as to reduce respiratory related complications.
Detailed description
40 ASA grade I - II patients were selected from the patients who underwent shoulder ligament rupture repair surgery under selective general anesthesia combined with brachial plexus block analgesia in the sports medical center of our hospital. They were randomly divided into two groups: high concentration group (group I) and low concentration group (Group II), with 20 cases in each group. 40 patients underwent a single brachial plexus block under ultrasound guidance before general anesthesia. In group I, ropivacaine 100mg + normal saline to 20ml (0.5% ropivacaine 20ml), and in group II, ropivacaine 40mg + normal saline to 20ml (0.2% ropivacaine 20ml). The high-frequency ultrasonic probe was located in the intermuscular sulcus, clearly exposing the three trunks of the brachial plexus. Using out of plane technology, the drug solution was injected around the brachial plexus, Ultrasonic images showed that the drug solution evenly wrapped the nerve trunks. The diaphragmatic movement of patients was scanned and recorded before and 30 minutes after block. The dispensing nurse, the operator and the follow-up doctor are independent individuals, and the operator and the follow-up doctor do not know the patient grouping. After confirming the effect of nerve block, the operating doctor will carry out general anesthesia and start the operation. The patients were followed up 6 hours after operation, and NRS scores were made and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Active comparator | Drug: Different concentration of ropivacaine for single brachial plexus blockIn group I(high concentration group), ropivacaine 100mg + normal saline to 20ml (0.5% ropivacaine 20ml) is used for single brachial plexus block under ultrasound guidance before general anesthesia. |
| group II | Experimental | Drug: Different concentration of ropivacaine for single brachial plexus blockIn group II (low concentration group), ropivacaine 40mg + normal saline to 20ml (0.2% ropivacaine 20ml) is used for single brachial plexus block under ultrasound guidance before general anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- operation type: patients undergoing shoulder ligament rupture repair under selective general anesthesia combined with nerve block analgesia
- age: 18 ~ 65
- ASA class I or II
Key exclusion criteria (7 listed)
- patient rejection
- brachial plexus injury
- severe cardiovascular disease
- allergic to the drugs used in the test
- infection at the puncture site
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 |
|---|---|---|
| Different concentration of ropivacaine for single brachial plexus block40 ASA grade I - II patients were selected from the patients who underwent shoulder ligament rupture repair surgery under selective general anesthesia combined with brachial plexus block analgesia in the sports medical center of our hospital. They were randomly divided into two groups: high concentration group (group I) and low concentration group (Group II), with 20 cases in each group. 40 patients underwent a single brachial plexus block under ultrasound guidance before general anesthesia. | Drug | group I, group II |
Primary outcome
the maximum range of motion of bilateral diaphragm
Time frame: The ultrasound examination of bilateral diaphragms was carried out before brachial plexus block on the affected side, and the ultrasound examination of diaphragm on the blocked side was carried out again 10 minutes after local anesthetic
Using a low-frequency probe (3-5mhz), place the probe at the bilateral axillary front or at the junction of the clavicular midline and the costal margin respectively, and take the liver and spleen as the sound window, it can be seen that the diaphragm is in an arc-shaped strong echo line. Select the M-mode, and make the sampling line vertical to the diaphragm. Measure the motion amplitude / movement of the diaphragm during calm breathing and maximum deep breathing, and the vertical motion distance (CM) of the diaphragm in the inspiratory phase and expiratory phase respectively.
the change rate of diaphragm thickness
Time frame: The ultrasound examination of bilateral diaphragms was carried out before brachial plexus block on the affected side, and the ultrasound examination of diaphragm on the blocked side was carried out again 10 minutes after local anesthetic injection
Select the M-mode to make the sampling line vertical to the diaphragm, Measure the end inspiratory and end expiratory diaphragm thickness at calm breathing and maximum deep breathing respectively, and calculate the change rate of diaphragm thickness at calm breathing and maximum deep breathing [(end inspiratory diaphragm thickness - end expiratory diaphragm thickness) / end expiratory diaphragm thickness × 100%].
1 secondary outcome
Pain relief score of patients.
Time frame: 6 hours and 24 hours after operation
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 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Phrenic Paralysis
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Comparative Evaluation of Diaphragmatic Function Following Interscalene, Anterior Suprascapular, and Costoclavicular Nerve Blocks in Shoulder Surgery
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Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
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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 Different concentration of ropivacaine for single brachial plexus block in people with Phrenic Paralysis and Shoulder Joint Surgery, run by Peking University Third Hospital at 1 site in China.
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 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 15 Oct 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 China. 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 maximum range of motion of bilateral diaphragm (time frame: The ultrasound examination of bilateral diaphragms was carried out before brachial plexus block on the affected side, and the ultrasound examination of diaphragm on the blocked side was carried out again 10 minutes after local anesthetic). The study lists 2 primary outcomes in all. 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 15 Oct 2024.