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Clinical Trials/NCT01949480
NCT01949480
Completed
Not Applicable

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

University of Pittsburgh2 sites in 1 country45 target enrollmentJuly 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Paravertebral Peripheral Nerve Block
Sponsor
University of Pittsburgh
Enrollment
45
Locations
2
Primary Endpoint
Opioid Consumption at 24 Hours Postoperatively
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2013
End Date
June 5, 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anna Uskova

Clinical Assistant Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) I-III subjects
  • Ages 18-75 years
  • Scheduled for elective thoracic surgery at University of Pittsburgh Medical Center (UPMC) Passavant and Shadyside Hospitals in Pittsburgh, Pennsylvania
  • Patients willing and able to provide informed consent

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

  • Number of Local Anesthetic Boluses Requested by PCA(24 hours postoperatively)
  • Total Local Anesthetic Infusions Over 24- Hour Period(24 hours postoperatively)
  • Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)(Pre-operatively and at 24 hour post-operative)
  • Incentive Spirometry(Preoperatively and Postoperatively)
  • Respiratory Rate(24 hours postoperatively)
  • Forced Vital Capacity (FVC)(Preoperatively and postoperatively)
  • Sensory Level(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(24 hours post PCA initiation)
  • Forced Expiratory Volume in 1 Sec (FEV1)(Preoperatively and postoperatively)
  • Peak Expiratory Flow Rate(PEF)(Preoperatively and postoperatively)
  • Total Number of Local Anesthetic Boluses in 24 Hours(postoperatively, up to 24 hours)

Study Sites (2)

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