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Clinical Trials/NCT03868917
NCT03868917
Unknown
Not Applicable

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

Yeungnam University College of Medicine1 site in 1 country72 target enrollmentJanuary 2, 2019
ConditionsThoracotomy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thoracotomy
Sponsor
Yeungnam University College of Medicine
Enrollment
72
Locations
1
Primary Endpoint
visual analogue scale for pain (VAS) at 2 hour after the arrival of postanesthetic care unit (PACU)
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2019
End Date
December 31, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sangjin Park

professor

Yeungnam University College of Medicine

Eligibility Criteria

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

Outcomes

Primary Outcomes

visual analogue scale for pain (VAS) at 2 hour after the arrival of postanesthetic care unit (PACU)

Time Frame: 2 hour after the arrival of PACU

VAS 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).

Study Sites (1)

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