N/A
N=42
Ultrasound-Assisted Paravertebral Block v. Traditional Paravertebral Block For Pain Control
Paravertebral Peripheral Nerve Block · Acute Pain Management
Bottom Line
View on ClinicalTrials.gov: NCT01949480 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Opioid Consumption at 24 Hours Postoperatively — 5.75; 6.38 mg — p=0.643
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Thoracotomy (Procedure); Video-Assisted Thoracoscopic Surgery (VATS) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Consumption at 24 Hours Postoperatively |
5.75; 6.38 | 0.643 |
| SECONDARY Sensory Level |
3; 1 | — |
| SECONDARY Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing |
1.73; 2.92; 4; 4.77 | .077 |
| SECONDARY Number of Local Anesthetic Boluses Requested by PCA |
27.5; 48 | 0.605 |
| SECONDARY Total Local Anesthetic Infusions Over 24- Hour Period |
173; 186 | 0.104 |
| SECONDARY Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2) |
95; 94 | 0.308 |
| SECONDARY Incentive Spirometry |
0.658; 0.716 | 0.487 |
| SECONDARY Respiratory Rate |
17; 17.7 | 0.493 |
| SECONDARY Forced Vital Capacity (FVC) |
0.551; 0.504 | 0.574 |
| SECONDARY Forced Expiratory Volume in 1 Sec (FEV1) |
0.561; 0.571 | 0.913 |
| SECONDARY Peak Expiratory Flow Rate(PEF) |
0.568; 0.542 | 0.783 |
| SECONDARY Total Number of Local Anesthetic Boluses in 24 Hours |
1; 2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01949480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.