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Completed

NCT Number: NCT06640621

The Effect of Brachial Plexus Block 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.

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Key information

Conditions

Phrenic Paralysis Rotator Cuff Injuries Rotator Cuff Injury Rupture Shoulder Injuries Shoulder Joint Surgery Tendon Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Different concentration of ropivacaine for single brachial plexus block

Drug

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.

Primary outcomes

  1. 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.

  2. 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%].

Secondary outcomes

  1. Pain relief score of patients.

    Time frame: 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 .

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

A Randomized Controlled Study on the Effect of Brachial Plexus Block with Different Concentrations of Ropivacaine on Diaphragm Movement

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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