Clinical trial NCT03868917: Ultrasound-guided Approach Combined With Pressure Measurement Technique to Thoracic Paravertebral Block
Official title: Comparison of Ultrasound-guided Approach and Ultrasound-guided Approach Combined With Pressure Measurement Technique to Thoracic Paravertebral Block for Open Thoracotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracotomy
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant is randomized to one of two groups.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: visual analogue scale for pain (VAS) at 2 hour after the arrival of postanesthetic care unit (PACU)
timeFrame: 2 hour after the arrival of PACU
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
Study officials:
affiliation: Yeungnam University Hospital
name: SANGJIN PARK, MD
role: PRINCIPAL_INVESTIGATOR
References:
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):643-648. doi: 10.4103/ija.IJA_81_17.
citation: 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.