Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure.

NCT03151434 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 1601583558
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare three different pain control methods on subjects who are scheduled to undergo VATS (video-assisted thoracoscopic surgery) procedures. The study will compare their pain scores, narcotic needs, patient satisfaction scores, and narcotic side effects.

Conditions

Video Assisted Thoracoscopic Surgery; Pain, Postoperative; Pain, Acute

Keywords

VATS; pain

Outcome Measures

Primary Outcomes (2)

• The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours

  The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using "units on a scale" of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  Pain scores will be measured 24 hours after surgery.

• The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours

  The VAS scores will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using"units on a scale" scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  Pain scores will be measured 48 hours after surgery.

Secondary Outcomes (1)

• Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours

  Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.

Other Outcomes (4)

• Average Nausea Scores Over 72 Hours

  Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.The scores will then be averaged.

• Average Sedation Scores Over 72 Hours

  Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.

• Subjects Overall Satisfaction Scores

  post operatively at hour 24

Study Arms (3)

Group #1

ACTIVE COMPARATOR

US Guided Single Shot Paravertebral Block

Drug: US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion)

Group #2

ACTIVE COMPARATOR

US Guided Paravertebral Catheter

Drug: US Guided Paravertebral Catheter (0.2% ropivicaine bolus)

Group #3

ACTIVE COMPARATOR

Thoracic Epidural

Drug: Thoracic Epidural (0.125% bupivicaine/hydromorphone)

Interventions

US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion) DRUG

Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.

Also known as: US Guided Single Shot Paravertebral Block

Group #1

US Guided Paravertebral Catheter (0.2% ropivicaine bolus) DRUG

Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.

Also known as: US Guided Paravertebral Catheter

Group #2

Thoracic Epidural (0.125% bupivicaine/hydromorphone) DRUG

Epidural catheter will be placed in the thoracic region prior to surgery.

Group #3

Eligibility Criteria

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

You may qualify if:

• Pt undergoing VATS procedure at Indiana University Hospital
• ASA 1,2,3 or 4
• Age 18 or older, male or female
• Desires Regional anesthesia for postoperative pain control

You may not qualify if:

• Any contraindication for Thoracic Epidural or Paravertebral block
• History of substance abuse in the past 6 months
• Patient staying intubated after surgery
• Known allergy or other contraindications to the study medications , which include dilaudid, bupivacaine, ropivacaine

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (17)

• Bottiger BA, Esper SA, Stafford-Smith M. Pain management strategies for thoracotomy and thoracic pain syndromes. Semin Cardiothorac Vasc Anesth. 2014 Mar;18(1):45-56. doi: 10.1177/1089253213514484. Epub 2013 Dec 12.

  PMID: 24336691 BACKGROUND

• Daly DJ, Myles PS. Update on the role of paravertebral blocks for thoracic surgery: are they worth it? Curr Opin Anaesthesiol. 2009 Feb;22(1):38-43. doi: 10.1097/ACO.0b013e32831a4074.

  PMID: 19237975 BACKGROUND

• Dango S, Harris S, Offner K, Hennings E, Priebe HJ, Buerkle H, Passlick B, Loop T. Combined paravertebral and intrathecal vs thoracic epidural analgesia for post-thoracotomy pain relief. Br J Anaesth. 2013 Mar;110(3):443-9. doi: 10.1093/bja/aes394. Epub 2012 Nov 14.

  PMID: 23151421 BACKGROUND

• Davies RG, Myles PS, Graham JM. A comparison of the analgesic efficacy and side-effects of paravertebral vs epidural blockade for thoracotomy--a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2006 Apr;96(4):418-26. doi: 10.1093/bja/ael020. Epub 2006 Feb 13.

  PMID: 16476698 BACKGROUND

• El-Morsy, W. Z. (2013). Thoracic epidural analgesia versus parenteral morphine for post-thoracotomy pain relief. Ain-Shams Journal of Anaesthesiology, 6(2), 180.

  BACKGROUND

• Fortier S, Hanna HA, Bernard A, Girard C. Comparison between systemic analgesia, continuous wound catheter analgesia and continuous thoracic paravertebral block: a randomised, controlled trial of postthoracotomy pain management. Eur J Anaesthesiol. 2012 Nov;29(11):524-30. doi: 10.1097/EJA.0b013e328357e5a1.

  PMID: 22914044 BACKGROUND

• Fibla JJ, Molins L, Mier JM, Sierra A, Carranza D, Vidal G. The efficacy of paravertebral block using a catheter technique for postoperative analgesia in thoracoscopic surgery: a randomized trial. Eur J Cardiothorac Surg. 2011 Oct;40(4):907-11. doi: 10.1016/j.ejcts.2010.12.043. Epub 2011 Feb 11.

  PMID: 21316259 BACKGROUND

• Helms O, Mariano J, Hentz JG, Santelmo N, Falcoz PE, Massard G, Steib A. Intra-operative paravertebral block for postoperative analgesia in thoracotomy patients: a randomized, double-blind, placebo-controlled study. Eur J Cardiothorac Surg. 2011 Oct;40(4):902-6. doi: 10.1016/j.ejcts.2011.01.067. Epub 2011 Mar 5.

  PMID: 21377888 BACKGROUND

• Kaya FN, Turker G, Mogol EB, Bayraktar S. Thoracic paravertebral block for video-assisted thoracoscopic surgery: single injection versus multiple injections. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):90-4. doi: 10.1053/j.jvca.2011.09.008. Epub 2011 Nov 4.

  PMID: 22055006 BACKGROUND

• Komatsu T, Sowa T, Takahashi K, Fujinaga T. Paravertebral block as a promising analgesic modality for managing post-thoracotomy pain. Ann Thorac Cardiovasc Surg. 2014;20(2):113-6. doi: 10.5761/atcs.oa.12.01999. Epub 2013 Feb 28.

  PMID: 23445804 BACKGROUND

• Mackay, J. H., & Gray, S. J. (2013). Principles and Practice of Anesthesia for Thoracic Surgery. British Journal of Anaesthesia, 110(5), 857-858.

  BACKGROUND

• 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

• Shelley B, Macfie A. Where now for thoracic paravertebral blockade? Anaesthesia. 2012 Dec;67(12):1317-20. doi: 10.1111/j.1365-2044.2012.07310.x. No abstract available.

  PMID: 23130723 BACKGROUND

• Slater, B., & Frost, E. A. (2012). Pain Management After Thoracic Surgery.Topics in Pain Management, 28(3), 1-8.

  BACKGROUND

• Yoshida T, Fujiwara T, Furutani K, Ohashi N, Baba H. Effects of ropivacaine concentration on the spread of sensory block produced by continuous thoracic paravertebral block: a prospective, randomised, controlled, double-blind study. Anaesthesia. 2014 Mar;69(3):231-9. doi: 10.1111/anae.12531. Epub 2014 Jan 21.

  PMID: 24447266 BACKGROUND

• Yoshioka M, Mori T, Kobayashi H, Iwatani K, Yoshimoto K, Terasaki H, Nomori H. The efficacy of epidural analgesia after video-assisted thoracoscopic surgery: a randomized control study. Ann Thorac Cardiovasc Surg. 2006 Oct;12(5):313-8.

  PMID: 17095972 BACKGROUND

• Yeap YL, Wolfe JW, Backfish-White KM, Young JV, Stewart J, Ceppa DP, Moser EAS, Birdas TJ. Randomized Prospective Study Evaluating Single-Injection Paravertebral Block, Paravertebral Catheter, and Thoracic Epidural Catheter for Postoperative Regional Analgesia After Video-Assisted Thoracoscopic Surgery. J Cardiothorac Vasc Anesth. 2020 Jul;34(7):1870-1876. doi: 10.1053/j.jvca.2020.01.036. Epub 2020 Jan 25.

  PMID: 32144059 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Pain

Interventions

Tea; Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Yar Luan Yeap
• Organization: Indiana University Department of Anesthesiology

yyeap@iupui.edu

3172740275

Study Officials

• Yar Yeap, MD

  Indiana University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Acute Pain Service Assistant Professor of Clinical Anesthesiology Indiana University School of Medicine Department of Anesthesiology

Model Details: Patients randomized to epidural, single shot paravertebral block, and paravertebral catheter

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: May 12, 2017
• Study Start: February 7, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: January 27, 2021
• Results First Posted: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)