Trial record 2 of 553 for:    Open Studies | "Pain Management"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Anna Uskova, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01949480
First received: September 19, 2013
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Paravertebral Peripheral Nerve Block
Acute Pain Management
Procedure: Thoracotomy
Procedure: Video-Assisted Thoracoscopic Surgery (VATS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Of Ultrasound-Assisted Paravertebral Block And Traditional Paravertebral Block For Pain Control After Thoracic Surgery, A Prospective Randomized Trial

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Opioid consumption at 24 hours postoperatively [ Time Frame: 24 hours after PCA was initiated ] [ Designated as safety issue: No ]
    Hydromorphone (Dilaudid) consumption or opiate equivalent at 24-hour interval post PCA initiation at the PACU.


Secondary Outcome Measures:
  • Sensory level [ Time Frame: 6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block. ] [ Designated as safety issue: No ]
    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.

  • Pain 11-point numerical rating scale (NRS)at rest and with deep breathing [ Time Frame: 24 hours post PCA initiation ] [ Designated as safety issue: No ]
    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.

  • Number of local anesthetic boluses [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    The number of local anesthetic boluses over 24- hour period post PCA initiation will also be recorded.

  • Total local anesthestic consumption [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    The total local anesthetic consumption over 24- hour period.

  • Inspired oxygen concentration and SpO2 [ Time Frame: Twice within the 24 hour period postoperatively ] [ Designated as safety issue: No ]
    Inspired oxygen concentration and SpO2 preoperatively and at 24 - hour interval.

  • Incentive spirometry [ Time Frame: Preoperatively and postoperatively ] [ Designated as safety issue: No ]
    Inspiratory Volume as measured by incentive spirometer preoperatively and at 24 hours post PCA initiation.

  • Respiratory rate [ Time Frame: Preoperatively and postoperatively ] [ Designated as safety issue: No ]
    Respiratory rate (RR) per minute preoperatively and at 24 - hour interval

  • Forced vital capacity (FVC) [ Time Frame: Preoperatively and postoperatively ] [ Designated as safety issue: No ]
    Forced vital capacity (FVC) preoperatively and at 24 - hour interval

  • Forced expiratory volume in 1 sec (FEV1) preoperatively and at 24 - hour interval Forced expiratory volume [ Time Frame: Preoperatively and postoperatively ] [ Designated as safety issue: No ]
    Forced expiratory volume in 1 sec (FEV1) preoperatively and at 24 - hour interval

  • Peak expiratory flow rate(PEFR) [ Time Frame: Preoperatively and postoperatively ] [ Designated as safety issue: No ]
    Peak expiratory flow rate preoperatively (PEFR) and at 24 - hour interval.


Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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 hydromorpone (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. ASA I-III subjects
  • 2. Ages 18-75 years
  • 3. BMI < 40
  • 4. Scheduled for elective thoracic surgery at 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, hypocoaguable 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 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 tranverse process fractures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949480

Locations
United States, Pennsylvania
UPMC Presbyterian Shadyside Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Katie L Vulakovich    412-623-6382    vulakovichkl@upmc.edu   
Sub-Investigator: Jacques E Chelly, MD, PhD, MBA         
Sub-Investigator: Bruce Ben-David, MD         
Sub-Investigator: Shiv Goel, MD         
Sub-Investigator: Ryan Guffey, MD         
Sub-Investigator: Arie Kandel, MD         
Sub-Investigator: Sharad Khetarpal, MD         
Sub-Investigator: Rita B Merman, MD         
Sub-Investigator: Sudhakar Yennam, MD         
UPMC Passavant Recruiting
Pittsburgh, Pennsylvania, United States, 15237
Contact: Katie L Vulakovich    412-623-6382    vulakovichkl@upmc.edu   
Sub-Investigator: Kevin K King, DO         
Sub-Investigator: Touichi Kawabe, MD         
Sub-Investigator: David Glover, DO         
Sub-Investigator: Vimala Ramesh, MD         
Sub-Investigator: Charles Luke, MD         
Sponsors and Collaborators
University of Pittsburgh
  More Information

Additional Information:
Publications:

Responsible Party: Anna Uskova, Clinical Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01949480     History of Changes
Other Study ID Numbers: PRO09090367
Study First Received: September 19, 2013
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Peripheral nerve block
Ultrasound guidance
Postoperative pain management post status thoracotomy
Postoperative pain management post status VATS

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014