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

August 17, 2018 updated by: Anna Uskova, University of Pittsburgh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15237
        • UPMC Passavant
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Presbyterian Shadyside

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional approach paravertebral nerve block
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
Procedure: Video-Assisted Thoracoscopic Surgery (VATS)
Experimental: Ultrasound assisted paravertebral nerve block
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
Procedure: Video-Assisted Thoracoscopic Surgery (VATS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption at 24 Hours Postoperatively
Time Frame: 24 hours after patient-controlled analgesia (PCA) was initiated
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
Time Frame: 6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.
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
Time Frame: 24 hours post PCA initiation
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
Time Frame: 24 hours postoperatively
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
Time Frame: 24 hours postoperatively
The total local anesthetic infusions over 24- hour period.
24 hours postoperatively
Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)
Time Frame: Pre-operatively and at 24 hour post-operative
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
Time Frame: Preoperatively and Postoperatively
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
Time Frame: 24 hours postoperatively
Respiratory rate (RR) per minute after surgery.
24 hours postoperatively
Forced Vital Capacity (FVC)
Time Frame: Preoperatively and postoperatively
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)
Time Frame: Preoperatively and postoperatively
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)
Time Frame: Preoperatively and postoperatively
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
Time Frame: postoperatively, up to 24 hours
Total Number of Local Anesthetic bolus doses given within the 24-hours post-operatively.
postoperatively, up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

June 5, 2014

Study Completion (Actual)

June 5, 2014

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO09090367

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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