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

NCT01949480 | Completed Results DMC

• 1 other identifier: PRO09090367
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  24 hours after patient-controlled analgesia (PCA) was initiated

Secondary Outcomes (11)

• 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

• 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

Study Arms (2)

Traditional approach paravertebral nerve block

ACTIVE COMPARATOR

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)

Ultrasound assisted paravertebral nerve block

EXPERIMENTAL

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)

Interventions

Thoracotomy PROCEDURE

Traditional approach paravertebral nerve block; Ultrasound assisted paravertebral nerve block

Video-Assisted Thoracoscopic Surgery (VATS) PROCEDURE

Traditional approach paravertebral nerve block; Ultrasound assisted paravertebral nerve block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. American Society of Anesthesiologists (ASA) I-III subjects
• \. Ages 18-75 years
• \. BMI \< 40
• \. 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (2)

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC Passavant

Pittsburgh, Pennsylvania, 15237, United States

Location

Related Publications (18)

• 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.

  PMID: 10655907 BACKGROUND

• 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.

  PMID: 7577277 BACKGROUND

• 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.

  PMID: 2923769 BACKGROUND

• 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.

  PMID: 7573876 BACKGROUND

• 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.

  PMID: 16199417 BACKGROUND

• 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.

  PMID: 10527232 BACKGROUND

• 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.

  PMID: 7618963 BACKGROUND

• 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.

  PMID: 10825328 BACKGROUND

• 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.

  PMID: 10456819 BACKGROUND

• 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.

  PMID: 8678263 BACKGROUND

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

  PMID: 1286056 BACKGROUND

• 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.

  PMID: 11251143 BACKGROUND

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

  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.

  PMID: 11812698 BACKGROUND

• 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.

  PMID: 6168207 BACKGROUND

• 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.

  PMID: 14570677 BACKGROUND

• 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.

  PMID: 15200537 BACKGROUND

• 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.

  PMID: 19244265 BACKGROUND

Related Links

• University of Pittsburgh Institutional Review Board
• University of Pittsburgh Department of Anesthesiology

MeSH Terms

Interventions

Thoracotomy; Thoracic Surgery, Video-Assisted

Intervention Hierarchy (Ancestors)

Thoracic Surgical Procedures; Surgical Procedures, Operative; Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Dr. Anna Uskova, Principal Investigator
• Organization: University of Pittsburgh

UskoAA@anes.upmc.edu

412) 623-2167

Study Officials

• Anna Uskova, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: September 24, 2013
• Study Start: July 1, 2013
• Primary Completion: June 5, 2014
• Study Completion: June 5, 2014
• Last Updated: January 22, 2019
• Results First Posted: January 22, 2019

Record last verified: 2018-08

Locations

US (2)