Clinical trial NCT03151434: Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure.
Official title: Randomized Prospective Study Comparing Paravertebral Catheters, Single Shot Paravertebral Block, Thoracic Epidural, for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Video Assisted Thoracoscopic Surgery
Pain, Postoperative
Pain, Acute
Keywords: VATS
pain
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients randomized to epidural, single shot paravertebral block, and paravertebral catheter
Primary purpose: TREATMENT

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.

Detailed description: All patients will be consented on the morning of surgery. All the thoracic epidurals and ultrasound-guided paravertebral blocks will be placed preoperatively. The procedures will be done using sterile technique with masks, hats, and sterile gloves. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.

Thoracic epidurals will be placed using the Arrow thoracic epidural kit. The epidural will be placed at the appropriate level to cover the entry site for the VATS procedure. Placement will be determined by anatomical landmarks. The epidural needle will be advanced toward the epidural space utilizing a Paramedian approach and loss-of-resistance technique. A sterile catheter will then be secured in place and the epidural infusion will be started at the end of the case.

Ultrasound guided paravertebral catheter and single shot paravertebral block will be accomplished using an ultrasound transducer at the thoracic level. This will be done using an in-plane or out-of-plane approach, at the discretion of the anesthesia staff performing the procedure. Then a needle will be inserted the needle into the paravertebral space and local anesthetic injected. Then a catheter will be placed within the injectate and secured in place in the case of the paravertebral catheter. The 0.2% Ropivicaine will be delivered by OnQ pump.

General anesthesia will be induced and the patient will be placed in the lateral position for the VATS procedure. The patients will be intubated with dual lumen endotracheal tubes and placed on one-lung ventilation for the procedure.

All patients will receive intravenous patient-controlled analgesia (PCA hydromorphone) post-operatively for breakthrough pain. They will also be scheduled on PO acetaminophen. PO oxycodone PRN will be started on POD 1 once patients tolerate diet.

Opioid usage at 1,24,48,72 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement (knee flexion) will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24, 48 and 72 hours after the epidural or PVB. Patients will be encouraged to ambulate on postoperative day 1 under supervision.

All catheters will be removed by APS (Acute Pain Service) while patients are still in the hospital. APS will continue to follow the patients until catheter removal. Patient's hospital length of stay and readmission rate will be recorded from NSQIP (National Surgical Quality Improvement Program) data.

All patients will receive a phone call 6 months after surgery for assessment for chronic post-surgical pain. Patients will be assessed by a member of the research team over the phone. They will be assessed on their pain score and narcotic usage by using the Brief Pain Inventory. Study participation will conclude after the 6 month follow questionnaire has been completed.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours
timeFrame: Pain scores will be measured 24 hours after surgery.
measure: The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours
timeFrame: Pain scores will be measured 48 hours after surgery.
Secondary outcomes:
measure: Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours
timeFrame: 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:
measure: Average Nausea Scores Over 72 Hours
timeFrame: Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.The scores will then be averaged.
measure: Average Sedation Scores Over 72 Hours
timeFrame: Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.
measure: Subjects Overall Satisfaction Scores
timeFrame: post operatively at hour 24
measure: Subjects Overall Satisfaction Scores
timeFrame: post operatively at hour 48
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University Hospital
name: Yar Yeap, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: El-Morsy, W. Z. (2013). Thoracic epidural analgesia versus parenteral morphine for post-thoracotomy pain relief. Ain-Shams Journal of Anaesthesiology, 6(2), 180.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Mackay, J. H., & Gray, S. J. (2013). Principles and Practice of Anesthesia for Thoracic Surgery. British Journal of Anaesthesia, 110(5), 857-858.
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.
citation: 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.
citation: Slater, B., & Frost, E. A. (2012). Pain Management After Thoracic Surgery.Topics in Pain Management, 28(3), 1-8.
citation: 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.
citation: 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.
citation: 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.