The Effect of Brachial Plexus Block on Diaphragm Movement

NCT06640621 | Completed DMC

• 2 other identifiers: M2021684LM2022383
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Phrenic Paralysis; Shoulder Joint Surgery; Rotator Cuff Injury

Keywords

brachial plexus block; diaphragm movement

Outcome Measures

Primary Outcomes (2)

• 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.

  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 \[(end inspiratory diaphragm thickness - end expiratory diaphragm thickness) / end expiratory diaphragm thickness × 100%\].

  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.

  6 hours and 24 hours after operation

Study Arms (2)

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.

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.

Drug: Different concentration of ropivacaine for single brachial plexus block

Interventions

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.

group I; group II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Brachial Plexus Block

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: October 15, 2024
• Study Start: November 8, 2022
• Primary Completion: October 7, 2023
• Study Completion: October 7, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)