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

NCT ID: NCT01949480

Last Updated: 2019-01-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-01

Study Completion Date

2014-06-05

Brief Summary

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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

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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.

Conditions

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Paravertebral Peripheral Nerve Block Acute Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Thoracotomy

Intervention Type PROCEDURE

Video-Assisted Thoracoscopic Surgery (VATS)

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

Thoracotomy

Intervention Type PROCEDURE

Video-Assisted Thoracoscopic Surgery (VATS)

Intervention Type PROCEDURE

Interventions

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Thoracotomy

Intervention Type PROCEDURE

Video-Assisted Thoracoscopic Surgery (VATS)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Anna Uskova

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Uskova, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, United States

Site Status

UPMC Passavant

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10655907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7577277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2923769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7573876 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16199417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10527232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7618963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10825328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10456819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8678263 (View on PubMed)

Kirvela O, Antila H. Thoracic paravertebral block in chronic postoperative pain. Reg Anesth. 1992 Nov-Dec;17(6):348-50.

Reference Type BACKGROUND
PMID: 1286056 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11251143 (View on PubMed)

Chelly JE. Peripheral Nerve Blocks: A Color Atlas. 2009. Third Edition. Lippincott Williams and Wilkins.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 11812698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6168207 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14570677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15200537 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19244265 (View on PubMed)

Related Links

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http://www.irb.pitt.edu/

University of Pittsburgh Institutional Review Board

http://www.anes.upmc.edu/

University of Pittsburgh Department of Anesthesiology

Other Identifiers

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PRO09090367

Identifier Type: -

Identifier Source: org_study_id

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