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

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.

Study Overview

• Status: Unknown
• Conditions: Thoracotomy
• Intervention / Treatment: Procedure: thoracic paravertebral block using pressure measurement technique

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 705-035
    • Recruiting
    • Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
    • Principal Investigator: Sangjin Park, M.D.
    • Contact: Duckhee Lee, M.D.; Phone Number: 82-53-620-3365; Email: apsj0718@yu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: ultrasound group; The participants have continuous thoracic paravertebral block performed using only the ultrasound approach.
Experimental: pressure measurement group; The participants have continuous thoracic paravertebral block performed using the ultrasound-guided approach combined with pressure measurement techniqueduring needle advancement.	Procedure: thoracic paravertebral block using pressure measurement technique; The continuous thoracic paravertebral block using ultrasound machine is combined with pressure measurement during needle advancement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale for pain (VAS) at 2 hour after the arrival of postanesthetic care unit (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).	2 hour after the arrival of PACU

Collaborators and Investigators

• Sponsor: Yeungnam University College of Medicine
• Investigators: Principal Investigator: SANGJIN PARK, MD, Yeungnam University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: apsj07180304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: IPD sharing is needed to get permission from IRB.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No