Ultrasound-Assisted Paravertebral Block v. Traditional Paravertebral Block For Pain Control

Study Overview
=================
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.

Official Title
-----------------
Comparison Of Ultrasound-Assisted Paravertebral Block And Traditional Paravertebral Block For Pain Control After Thoracic Surgery, A Prospective Randomized Trial

Conditions
-----------------
Paravertebral Peripheral Nerve Block, Acute Pain Management

Intervention / Treatment
-----------------
* Procedure: Thoracotomy
* Procedure: Video-Assisted Thoracoscopic Surgery (VATS)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional approach paravertebral nerve block<br>After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing. | Procedure: Thoracotomy<br> <br> Procedure: Video-Assisted Thoracoscopic Surgery (VATS)<br> <br> |
| Experimental: Ultrasound assisted paravertebral nerve block<br>The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing. | Procedure: Thoracotomy<br> <br> Procedure: Video-Assisted Thoracoscopic Surgery (VATS)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption at 24 Hours Postoperatively | Hydromorphone (Dilaudid) consumption or opiate equivalent at 24-hour interval post PCA initiation at the post-anesthesia care unit (PACU). | 24 hours after patient-controlled analgesia (PCA) was initiated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory Level | Sensory level as assessed by temperature and pin prick test assessed every 5 min for 30 min after nerve block as defined as the patient returning to their bed. Data below are in number of patients who didn't have any change during the ice and pin prik test. | 6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block. | 
| Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing | The pain level assessed using an 11-point numerical rating scale (NRS) with 0 indicating no pain and 10 indicating the worst pain possible with deep breathing and rest at 24 hours post PCA initiation. | 24 hours post PCA initiation | 
| Number of Local Anesthetic Boluses Requested by PCA | The number of local anesthetic boluses over 24- hour period post PCA initiation will also be recorded. | 24 hours postoperatively | 
| Total Local Anesthetic Infusions Over 24- Hour Period | The total local anesthetic infusions over 24- hour period. | 24 hours postoperatively | 
| Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2) | Inspired oxygen concentration and SpO2 preoperatively and at 24 - hour interval. Value reported is an average of the preoperative and the 24-hour postoperative SpO2 measurements. | Pre-operatively and at 24 hour post-operative | 
| Incentive Spirometry | Inspiratory Volume as measured by incentive spirometer preoperatively and at 24 hours post PCA initiation. The data is reported as a percentage in change from per-surgery measurements (post-surgery/pre-surgery). | Preoperatively and Postoperatively | 
| Respiratory Rate | Respiratory rate (RR) per minute after surgery. | 24 hours postoperatively | 
| Forced Vital Capacity (FVC) | Forced vital capacity (FVC) measured preoperatively and at 24 - hour interval. Then values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery). | Preoperatively and postoperatively | 
| Forced Expiratory Volume in 1 Sec (FEV1) | Forced expiratory volume in 1 sec (FEV1) preoperatively and at 24 - hour interval. Then the values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery). | Preoperatively and postoperatively | 
| Peak Expiratory Flow Rate(PEF) | Peak expiratory flow rate preoperatively (PEF) and at 24 - hour interval. Then values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery). | Preoperatively and postoperatively | 
| Total Number of Local Anesthetic Boluses in 24 Hours | Total Number of Local Anesthetic bolus doses given within the 24-hours post-operatively. | postoperatively, up to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral nerve block, Ultrasound guidance, Postoperative pain management post status thoracotomy, Postoperative pain management post status VATS