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

Thoracotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03868917
• Other study ID #: apsj07180304
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2019
• Source: Yeungnam University College of Medicine
• Contact: SANGJIN PARK, MD
• Phone: 82-53-620-3366
• Email: apsj0718[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Thoracotomy

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yeungnam University hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Župcic M, Graf Župcic S, Duzel V, Šimurina T, Šakic L, Fuduric J, Peršec J, Miloševic M, Stanec Z, Korušic A, Barišin S. A combination of levobupivacaine and lidocaine for paravertebral block in breast cancer patients undergoing quadrantectomy causes grea — View Citation

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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