Ultrasound-guided Approach Combined With Pressure Measurement Technique to Thoracic Paravertebral Block

NCT ID: NCT03868917

Last Updated: 2019-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2019-12-31

Brief Summary

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Posterolateral thoracotomies are among the most painful procedures of surgery and may cause severe postoperative chest pain and impaired respiratory performance. Paravertebral block (PVB) is an established method of administering postoperative analgesia for thoracic procedures. PVB blocks the somatic and sympathetic nervous systems and is placed by injecting a local anesthetic (LA) into the paravertebral space where the nerve and its branches are located after exiting the intervertebral foramen. But previous study showed 5-10% of failure rate in PVB using ultrasound machine. Pressure measurement during needle advancement could improve reliability of correct needle placement. When the needle tip reaches paravertebral space, there is a sudden lowering of pressures due to respiratory cycle. Therefore, sensitivity and specificity could be improved and correct needle placement become objective and reproducible when PVB using ultrasound is combined with pressure measurement during needle advancement.

Detailed Description

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Conditions

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Thoracotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each participant is randomized to one of two groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ultrasound group

The participants have continuous thoracic paravertebral block performed using only the ultrasound approach.

Group Type NO_INTERVENTION

No interventions assigned to this group

pressure measurement group

The participants have continuous thoracic paravertebral block performed using the ultrasound-guided approach combined with pressure measurement techniqueduring needle advancement.

Group Type EXPERIMENTAL

thoracic paravertebral block using pressure measurement technique

Intervention Type PROCEDURE

The continuous thoracic paravertebral block using ultrasound machine is combined with pressure measurement during needle advancement.

Interventions

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thoracic paravertebral block using pressure measurement technique

The continuous thoracic paravertebral block using ultrasound machine is combined with pressure measurement during needle advancement.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Scheduled for elective thoracotomy
* ASA status 1,2

Exclusion Criteria

* Inability to provide adequate informed consent
* Any contraindication to the placement of thoracic paravertebral catheters
* Unstable vertebral and transverse process fractures
* Any chronic painful conditions or preoperative opioid use Any chronic painful conditions or preoperative opioid use
* Coagulation abnormalities or expectation to be on therapeutic anticoagulants postoperatively
* Allergy to any of the drugs/agents used in study protocol
* Altered mental status or emergency surgery
* Comorbid conditions such as sepsis, unstable angina, congestive heart failure
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeungnam University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sangjin Park

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SANGJIN PARK, MD

Role: PRINCIPAL_INVESTIGATOR

Yeungnam University Hospital

Locations

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Department of Anesthesiology and Pain Medicine, Yeungnam University hospital

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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SANGJIN PARK, MD

Role: CONTACT

82-53-620-3366

Facility Contacts

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Duckhee Lee, M.D.

Role: primary

82-53-620-3365

References

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Syal K, Chandel A. Comparison of the post-operative analgesic effect of paravertebral block, pectoral nerve block and local infiltration in patients undergoing modified radical mastectomy: A randomised double-blind trial. Indian J Anaesth. 2017 Aug;61(8):643-648. doi: 10.4103/ija.IJA_81_17.

Reference Type RESULT
PMID: 28890559 (View on PubMed)

Zupcic M, Graf Zupcic S, Duzel V, Simurina T, Sakic L, Fuduric J, Persec J, Milosevic M, Stanec Z, Korusic A, Barisin S. A combination of levobupivacaine and lidocaine for paravertebral block in breast cancer patients undergoing quadrantectomy causes greater hemodynamic oscillations than levobupivacaine alone. Croat Med J. 2017 Aug 31;58(4):270-280. doi: 10.3325/cmj.2017.58.270.

Reference Type RESULT
PMID: 28857520 (View on PubMed)

Other Identifiers

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apsj07180304

Identifier Type: -

Identifier Source: org_study_id

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