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

Comparison of Ultrasound-guided Approach and Ultrasound-guided Approach Combined With Pressure Measurement Technique to Thoracic Paravertebral Block for Open Thoracotomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03868917
Enrollment
72
Registered
2019-03-11
Start date
2019-01-02
Completion date
2019-12-31
Last updated
2019-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracotomy

Brief summary

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.

Interventions

PROCEDUREthoracic paravertebral block using pressure measurement technique

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

Sponsors

Yeungnam University College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Each participant is randomized to one of two groups.

Eligibility

Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
visual analogue scale for pain (VAS) at 2 hour after the arrival of postanesthetic care unit (PACU)2 hour after the arrival of PACUVAS score is measured at 2 hour after a patient arrives in PACU. The pain VAS is a unidimensional measure of pain intensity. The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme (no pain 0, maximal pain 100).

Countries

South Korea

Contacts

Primary ContactSANGJIN PARK, MD
apsj0718@naver.com82-53-620-3366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026