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

Not Applicable

• Conditions: Thoracotomy
• Interventions: Procedure: thoracic paravertebral block using pressure measurement technique

• Registration Number: NCT03868917
• Lead Sponsor: Yeungnam University College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-02
• Status Verified: 2019-03
• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-11
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-14
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yeungnam University hospital; 🇰🇷 Daegu, Korea, Republic of