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Completed

NCT Number: NCT01949480

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

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.

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Key information

Conditions

Paravertebral Peripheral Nerve Block Acute Pain Management

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Passavant, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thoracotomy

Procedure

Video-Assisted Thoracoscopic Surgery (VATS)

Procedure

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Total Local Anesthetic Infusions Over 24- Hour Period

    Time frame: 24 hours postoperatively

    The total local anesthetic infusions over 24- hour period.

  5. 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.

  6. 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).

  7. Respiratory Rate

    Time frame: 24 hours postoperatively

    Respiratory rate (RR) per minute after surgery.

  8. 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).

  9. 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).

  10. 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).

  11. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 24, 2013
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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