Back to resultsUltrasound-Assisted Paravertebral Block v. Traditional Paravertebral Block For Pain Control
Primary Purpose
Paravertebral Peripheral Nerve Block, Acute Pain Management
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
Sponsored by
About this trial
This is an interventional treatment trial for Paravertebral Peripheral Nerve Block focused on measuring Peripheral nerve block, Ultrasound guidance, Postoperative pain management post status thoracotomy, Postoperative pain management post status VATS
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
Sites / Locations
- UPMC Presbyterian Shadyside
- UPMC Passavant
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional approach paravertebral nerve block
Ultrasound assisted paravertebral nerve block
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Opioid Consumption at 24 Hours Postoperatively
Hydromorphone (Dilaudid) consumption or opiate equivalent at 24-hour interval post PCA initiation at the post-anesthesia care unit (PACU).
Secondary Outcome Measures
Sensory Level
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.
Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing
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 Requested by PCA
The number of local anesthetic boluses over 24- hour period post PCA initiation will also be recorded.
Total Local Anesthetic Infusions Over 24- Hour Period
The total local anesthetic infusions over 24- hour period.
Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)
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.
Incentive Spirometry
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).
Respiratory Rate
Respiratory rate (RR) per minute after surgery.
Forced Vital Capacity (FVC)
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).
Forced Expiratory Volume in 1 Sec (FEV1)
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).
Peak Expiratory Flow Rate(PEF)
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).
Total Number of Local Anesthetic Boluses in 24 Hours
Total Number of Local Anesthetic bolus doses given within the 24-hours post-operatively.
Full Information
NCT ID
NCT01949480
First Posted
September 19, 2013
Last Updated
August 17, 2018
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT01949480
Brief Title
Ultrasound-Assisted Paravertebral Block v. Traditional Paravertebral Block For Pain Control
Official Title
Comparison Of Ultrasound-Assisted Paravertebral Block And Traditional Paravertebral Block For Pain Control After Thoracic Surgery, A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2013 (Actual)
Primary Completion Date
June 5, 2014 (Actual)
Study Completion Date
June 5, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paravertebral Peripheral Nerve Block, Acute Pain Management
Keywords
Peripheral nerve block, Ultrasound guidance, Postoperative pain management post status thoracotomy, Postoperative pain management post status VATS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional approach paravertebral nerve block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ultrasound assisted paravertebral nerve block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Thoracotomy
Intervention Type
Procedure
Intervention Name(s)
Video-Assisted Thoracoscopic Surgery (VATS)
Primary Outcome Measure Information:
Title
Opioid Consumption at 24 Hours Postoperatively
Description
Hydromorphone (Dilaudid) consumption or opiate equivalent at 24-hour interval post PCA initiation at the post-anesthesia care unit (PACU).
Time Frame
24 hours after patient-controlled analgesia (PCA) was initiated
Secondary Outcome Measure Information:
Title
Sensory Level
Description
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.
Time Frame
6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.
Title
Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing
Description
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.
Time Frame
24 hours post PCA initiation
Title
Number of Local Anesthetic Boluses Requested by PCA
Description
The number of local anesthetic boluses over 24- hour period post PCA initiation will also be recorded.
Time Frame
24 hours postoperatively
Title
Total Local Anesthetic Infusions Over 24- Hour Period
Description
The total local anesthetic infusions over 24- hour period.
Time Frame
24 hours postoperatively
Title
Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)
Description
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.
Time Frame
Pre-operatively and at 24 hour post-operative
Title
Incentive Spirometry
Description
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).
Time Frame
Preoperatively and Postoperatively
Title
Respiratory Rate
Description
Respiratory rate (RR) per minute after surgery.
Time Frame
24 hours postoperatively
Title
Forced Vital Capacity (FVC)
Description
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).
Time Frame
Preoperatively and postoperatively
Title
Forced Expiratory Volume in 1 Sec (FEV1)
Description
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).
Time Frame
Preoperatively and postoperatively
Title
Peak Expiratory Flow Rate(PEF)
Description
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).
Time Frame
Preoperatively and postoperatively
Title
Total Number of Local Anesthetic Boluses in 24 Hours
Description
Total Number of Local Anesthetic bolus doses given within the 24-hours post-operatively.
Time Frame
postoperatively, up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Uskova, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Presbyterian Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
UPMC Passavant
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
10655907
Citation
Richardson J, Sabanathan S, Jones J, Shah RD, Cheema S, Mearns AJ. A prospective, randomized comparison of preoperative and continuous balanced epidural or paravertebral bupivacaine on post-thoracotomy pain, pulmonary function and stress responses. Br J Anaesth. 1999 Sep;83(3):387-92. doi: 10.1093/bja/83.3.387.
Results Reference
background
PubMed Identifier
7577277
Citation
Perttunen K, Nilsson E, Heinonen J, Hirvisalo EL, Salo JA, Kalso E. Extradural, paravertebral and intercostal nerve blocks for post-thoracotomy pain. Br J Anaesth. 1995 Nov;75(5):541-7. doi: 10.1093/bja/75.5.541.
Results Reference
background
PubMed Identifier
2923769
Citation
Matthews PJ, Govenden V. Comparison of continuous paravertebral and extradural infusions of bupivacaine for pain relief after thoracotomy. Br J Anaesth. 1989 Feb;62(2):204-5. doi: 10.1093/bja/62.2.204.
Results Reference
background
PubMed Identifier
7573876
Citation
Lonnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5. doi: 10.1111/j.1365-2044.1995.tb06148.x.
Results Reference
background
PubMed Identifier
16199417
Citation
Vogt A, Stieger DS, Theurillat C, Curatolo M. Single-injection thoracic paravertebral block for postoperative pain treatment after thoracoscopic surgery. Br J Anaesth. 2005 Dec;95(6):816-21. doi: 10.1093/bja/aei250. Epub 2005 Sep 30.
Results Reference
background
PubMed Identifier
10527232
Citation
Ganapathy S, Murkin JM, Boyd DW, Dobkowski W, Morgan J. Continuous percutaneous paravertebral block for minimally invasive cardiac surgery. J Cardiothorac Vasc Anesth. 1999 Oct;13(5):594-6. doi: 10.1016/s1053-0770(99)90015-0. No abstract available.
Results Reference
background
PubMed Identifier
7618963
Citation
Weltz CR, Greengrass RA, Lyerly HK. Ambulatory surgical management of breast carcinoma using paravertebral block. Ann Surg. 1995 Jul;222(1):19-26. doi: 10.1097/00000658-199507000-00004.
Results Reference
background
PubMed Identifier
10825328
Citation
Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.
Results Reference
background
PubMed Identifier
10456819
Citation
Pusch F, Freitag H, Weinstabl C, Obwegeser R, Huber E, Wildling E. Single-injection paravertebral block compared to general anaesthesia in breast surgery. Acta Anaesthesiol Scand. 1999 Aug;43(7):770-4. doi: 10.1034/j.1399-6576.1999.430714.x.
Results Reference
background
PubMed Identifier
8678263
Citation
Richardson J, Vowden P, Sabanathan S. Bilateral paravertebral analgesia for major abdominal vascular surgery: a preliminary report. Anaesthesia. 1995 Nov;50(11):995-8. doi: 10.1111/j.1365-2044.1995.tb05939.x.
Results Reference
background
PubMed Identifier
1286056
Citation
Kirvela O, Antila H. Thoracic paravertebral block in chronic postoperative pain. Reg Anesth. 1992 Nov-Dec;17(6):348-50.
Results Reference
background
PubMed Identifier
11251143
Citation
Karmakar MK, Chui PT, Joynt GM, Ho AM. Thoracic paravertebral block for management of pain associated with multiple fractured ribs in patients with concomitant lumbar spinal trauma. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):169-73. doi: 10.1053/rapm.2001.21086.
Results Reference
background
Citation
Chelly JE. Peripheral Nerve Blocks: A Color Atlas. 2009. Third Edition. Lippincott Williams and Wilkins.
Results Reference
background
PubMed Identifier
11812698
Citation
Terheggen MA, Wille F, Borel Rinkes IH, Ionescu TI, Knape JT. Paravertebral blockade for minor breast surgery. Anesth Analg. 2002 Feb;94(2):355-9, table of contents. doi: 10.1097/00000539-200202000-00023.
Results Reference
background
PubMed Identifier
6168207
Citation
Evans PJ, Lloyd JW, Wood GJ. Accidental intrathecal injection of bupivacaine and dextran. Anaesthesia. 1981 Jul;36(7):685-7. doi: 10.1111/j.1365-2044.1981.tb08781.x.
Results Reference
background
PubMed Identifier
14570677
Citation
Chan VWS, Perlas A, Rawson R, Odukoya O. Ultrasound-guided supraclavicular brachial plexus block. Anesth Analg. 2003 Nov;97(5):1514-1517. doi: 10.1213/01.ANE.0000062519.61520.14.
Results Reference
background
PubMed Identifier
15200537
Citation
Marhofer P, Sitzwohl C, Greher M, Kapral S. Ultrasound guidance for infraclavicular brachial plexus anaesthesia in children. Anaesthesia. 2004 Jul;59(7):642-6. doi: 10.1111/j.1365-2044.2004.03669.x.
Results Reference
background
PubMed Identifier
19244265
Citation
Luyet C, Eichenberger U, Greif R, Vogt A, Szucs Farkas Z, Moriggl B. Ultrasound-guided paravertebral puncture and placement of catheters in human cadavers: an imaging study. Br J Anaesth. 2009 Apr;102(4):534-9. doi: 10.1093/bja/aep015. Epub 2009 Feb 24.
Results Reference
background
Links:
URL
http://www.irb.pitt.edu/
Description
University of Pittsburgh Institutional Review Board
URL
http://www.anes.upmc.edu/
Description
University of Pittsburgh Department of Anesthesiology
Learn more about this trial
Ultrasound-Assisted Paravertebral Block v. Traditional Paravertebral Block For Pain Control
We'll reach out to this number within 24 hrs