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

NCT03868917 | Unknown DMC

• 1 other identifier: apsj07180304
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracotomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ultrasound group

NO INTERVENTION

The participants have continuous thoracic paravertebral block performed using only the ultrasound approach.

pressure measurement group

EXPERIMENTAL

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

Interventions

thoracic paravertebral block using pressure measurement technique PROCEDURE

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

pressure measurement group

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for elective thoracotomy
• ASA status 1,2

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yeungnam University hospital

Daegu, 705-035, South Korea

RECRUITING

Related Publications (2)

• 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.

  PMID: 28890559 RESULT

• 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.

  PMID: 28857520 RESULT

Study Officials

• SANGJIN PARK, MD

  Yeungnam University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SANGJIN PARK, MD

CONTACT

82-53-620-3366; apsj0718@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Each participant is randomized to one of two groups.

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 11, 2019
• Study Start: January 2, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 14, 2019

Record last verified: 2019-03

Locations

KR (1)