The Effect of Brachial Plexus Block on Diaphragm Movement

Not Applicable

Completed

• Conditions: Phrenic Paralysis; Shoulder Joint Surgery; Rotator Cuff Injury
• Interventions: Drug: Different concentration of ropivacaine for single brachial plexus block

• Registration Number: NCT06640621
• Lead Sponsor: Peking University Third Hospital

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-11-01
• Study Start: 2022-11-08
• Primary Completion: 2023-10-07
• Study Completion: 2023-10-07
• Status Verified: 2024-06
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group I	Different concentration of ropivacaine for single brachial plexus block	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.
group II	Different concentration of ropivacaine for single brachial plexus block	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.

Primary Outcome Measures

Name	Time	Method
the maximum range of motion of bilateral diaphragm	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	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 \[(end inspiratory diaphragm thickness - end expiratory diaphragm thickness) / end expiratory diaphragm thickness × 100%\].

Secondary Outcome Measures

Name	Time	Method
Pain relief score of patients.	6 hours and 24 hours after operation	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 .

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China