Clinical trial NCT01949480: Ultrasound-Assisted Paravertebral Block v. Traditional Paravertebral Block For Pain Control
Official title: Comparison Of Ultrasound-Assisted Paravertebral Block And Traditional Paravertebral Block For Pain Control After Thoracic Surgery, A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paravertebral Peripheral Nerve Block
Acute Pain Management
Keywords: Peripheral nerve block
Ultrasound guidance
Postoperative pain management post status thoracotomy
Postoperative pain management post status VATS
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall purpose of this research study is to compare the effectiveness of ultrasound assisted paravertebral block placement versus traditional "blind" technique for postoperative analgesia following thoracotomy or visually assisted thoracoscopic surgery.

Detailed description: The purpose of this project is to determine if there is a difference between paravertebral block performed with ultrasound assistance and paravertebral block performed with traditional technique in terms of twenty - four hour hydromorphone (dilaudid) consumption and visual analogue pain scores at rest or with deep breathing at twenty - four hours. This study will determine if ultrasound technique used for placement of paravertebral catheter facilitates safety of paravertebral catheterization and improves therapeutic effect of paravertebral blockade for pain control after thoracotomy. The investigators will also examine if ultrasound assisted paravertebral blockade improves pulmonary status in post-thoracotomy patient.

Eligibility criteria: Inclusion Criteria:

* 1. American Society of Anesthesiologists (ASA) I-III subjects
* 2. Ages 18-75 years
* 3. BMI \< 40
* 4. Scheduled for elective thoracic surgery at University of Pittsburgh Medical Center (UPMC) Passavant and Shadyside Hospitals in Pittsburgh, Pennsylvania
* 5. Patients willing and able to provide informed consent

Exclusion Criteria:

* 1) Age younger than 18 years or older than 75 years
* (2) Any contraindication to the placement of unilateral thoracic paravertebral catheter, including local infection, hypocoagulable state.
* (3) American Society of Anesthesiologists physical status IV or greater
* (4) chronic painful conditions
* (5) preoperative opioid use
* (6) coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
* (7) allergy to lidocaine, ropivacaine or bupivacaine
* (8) personal or family history of malignant hyperthermia
* (9) serum creatinine greater than 1.4 g/dl
* (10) pregnancy or lactating.The pregnancy status will be determined by history and prior pregnancy testing when appropriate
* (11) having an altered mental status (not oriented to place, person, or time) or emergency surgery
* (12) comorbid conditions such as sepsis, unstable angina, congestive heart failure, moderate to severe valvular heart disease, severe chronic obstructive pulmonary disease (COPD)
* (13) patient's inability to provide adequate informed consent
* (14) patient refusal to nerve blocks and/or participation in the study
* (15) respiratory support via ventilator post
* (16) non English speaking
* (17) allergy to contrast of iodine
* (18) emergency surgery or any other non-elective procedure
* (19) unstable vertebral and transverse process fractures

Primary outcomes:
measure: Opioid Consumption at 24 Hours Postoperatively
timeFrame: 24 hours after patient-controlled analgesia (PCA) was initiated
Secondary outcomes:
measure: Sensory Level
timeFrame: 6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.
measure: Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing
timeFrame: 24 hours post PCA initiation
measure: Number of Local Anesthetic Boluses Requested by PCA
timeFrame: 24 hours postoperatively
measure: Total Local Anesthetic Infusions Over 24- Hour Period
timeFrame: 24 hours postoperatively
measure: Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)
timeFrame: Pre-operatively and at 24 hour post-operative
measure: Incentive Spirometry
timeFrame: Preoperatively and Postoperatively
measure: Respiratory Rate
timeFrame: 24 hours postoperatively
measure: Forced Vital Capacity (FVC)
timeFrame: Preoperatively and postoperatively
measure: Forced Expiratory Volume in 1 Sec (FEV1)
timeFrame: Preoperatively and postoperatively
measure: Peak Expiratory Flow Rate(PEF)
timeFrame: Preoperatively and postoperatively
measure: Total Number of Local Anesthetic Boluses in 24 Hours
timeFrame: postoperatively, up to 24 hours
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Shadyside
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Passavant
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Anna Uskova, MD
role: PRINCIPAL_INVESTIGATOR
References:
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