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

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03151434
• Collaborator: (none)
• Enrollment: 147
• Location: 1
• Arms: 3
• Actual Duration (Months): 17.7
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Video Assisted Thoracoscopic Surgery; Pain, Postoperative; Pain, Acute	Drug: US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion); Drug: US Guided Paravertebral Catheter (0.2% ropivicaine bolus); Drug: Thoracic Epidural (0.125% bupivicaine/hydromorphone)	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 147 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients randomized to epidural, single shot paravertebral block, and paravertebral catheterPatients randomized to epidural, single shot paravertebral block, and paravertebral catheter
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Prospective Study Comparing Paravertebral Catheters, Single Shot Paravertebral Block, Thoracic Epidural, for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery
• Actual Study Start Date: Feb 7, 2017
• Actual Primary Completion Date: Jul 30, 2018
• Actual Study Completion Date: Jul 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group #1 US Guided Single Shot Paravertebral Block	Drug: US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion); Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.; Other Names: US Guided Single Shot Paravertebral Block
Active Comparator: Group #2 US Guided Paravertebral Catheter	Drug: US Guided Paravertebral Catheter (0.2% ropivicaine bolus); Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.; Other Names: US Guided Paravertebral Catheter
Active Comparator: Group #3 Thoracic Epidural	Drug: Thoracic Epidural (0.125% bupivicaine/hydromorphone); Epidural catheter will be placed in the thoracic region prior to surgery.

Outcome Measures

Primary Outcome Measures

1. The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours [Pain scores will be measured 24 hours after surgery.]

   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

2. The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours [Pain scores will be measured 48 hours after surgery.]

   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

Secondary Outcome Measures

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.]

   Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements

Other Outcome Measures

1. 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.]

   Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as 0=none, 1=mild, 2=moderate, or 3=severe

2. 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.]

   Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is 0=awake and alert, 1=quietly awake, 2=asleep and arousable, or 3=deep sleep.

3. Subjects Overall Satisfaction Scores [post operatively at hour 24]

   Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. Score was recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.

4. Subjects Overall Satisfaction Scores [post operatively at hour 48]

   Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. Scores will be recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Hospital	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University

Investigators

• Principal Investigator: Yar Yeap, MD, Indiana University Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 15, 2018

More Information

Publications

• 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. Review.
• 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. Review.
• 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.
• 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. Epub 2006 Feb 13. Review. Erratum in: Br J Anaesth. 2007 Nov;99(5):768.
• El-Morsy, W. Z. (2013). Thoracic epidural analgesia versus parenteral morphine for post-thoracotomy pain relief. Ain-Shams Journal of Anaesthesiology, 6(2), 180.
• 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.
• 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.
• 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. Review.
• 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.
• 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. Epub 2013 Feb 28.
• Mackay, J. H., & Gray, S. J. (2013). Principles and Practice of Anesthesia for Thoracic Surgery. British Journal of Anaesthesia, 110(5), 857-858.
• 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.
• 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.
• Slater, B., & Frost, E. A. (2012). Pain Management After Thoracic Surgery.Topics in Pain Management, 28(3), 1-8.
• 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.
• 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.

• Responsible Party: Yar Yeap, Director, Acute Pain Service Assistant Professor of Clinical Anesthesiology Indiana University School of Medicine Department of Anesthesiology, Indiana University
• ClinicalTrials.gov Identifier: NCT03151434
• Other Study ID Numbers: 1601583558
• First Posted: May 12, 2017
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yar Yeap, Director, Acute Pain Service Assistant Professor of Clinical Anesthesiology Indiana University School of Medicine Department of Anesthesiology, Indiana University: VATS; pain
• Additional relevant MeSH terms: Pain, Postoperative; Acute Pain; Hydromorphone; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Group #1	Group #2	Group #3
Arm/Group Description	US Guided Single Shot Paravertebral Block US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.	US Guided Paravertebral Catheter US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.	Thoracic Epidural Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
Period Title: Overall Study
STARTED	53	47	47
COMPLETED	40	40	40
NOT COMPLETED	13	7	7

Baseline Characteristics

Arm/Group Title	US Guided Single Shot Paravertebral Block	US Guided Paravertebral Catheter	Thoracic Epidural	Total
Arm/Group Description	group 1- US Guided Single Shot Paravertebral Block US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.	group 2- US Guided Paravertebral Catheter US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.	group 3- Thoracic Epidural Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.	Total of all reporting groups
Overall Participants	40	40	40	120
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	63.5	62	61	62
Sex: Female, Male (Count of Participants)
Female	24 60%	21 52.5%	15 37.5%	60 50%
Male	16 40%	19 47.5%	25 62.5%	60 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	40 100%	40 100%	40 100%	120 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	8 20%	4 10%	1 2.5%	13 10.8%
White	32 80%	33 82.5%	39 97.5%	104 86.7%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	3 7.5%	0 0%	3 2.5%
Region of Enrollment (Count of Participants)
United States	40 100%	40 100%	40 100%	120 100%
height (Centimeter) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Centimeter]	171	167.6	173.5	170
weight (Kilogram) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Kilogram]	88.4	77.7	87.3	84.1

Outcome Measures

1. Primary Outcome

Title	The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours
Description	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
Time Frame	Pain scores will be measured 24 hours after surgery.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	US Guided Single Shot Paravertebral Block	US Guided Paravertebral Catheter	Thoracic Epidural
Arm/Group Description	group 1- US Guided Single Shot Paravertebral Block US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.	group 2- US Guided Paravertebral Catheter US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.	group 3- Thoracic Epidural Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
Measure Participants	40	40	40
Median (Inter-Quartile Range) [units on a scale]	4.0	4.5	3.0

2. Primary Outcome

Title	The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours
Description	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
Time Frame	Pain scores will be measured 48 hours after surgery.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	US Guided Single Shot Paravertebral Block	US Guided Paravertebral Catheter	Thoracic Epidural
Arm/Group Description	group 1- US Guided Single Shot Paravertebral Block US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.	group 2- US Guided Paravertebral Catheter US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.	group 3- Thoracic Epidural Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
Measure Participants	40	40	40
Median (Inter-Quartile Range) [units on a scale]	3.0	4.0	2.0

3. Secondary Outcome

Title	Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours
Description	Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements
Time Frame	Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group #1	Group #2	Group #3
Arm/Group Description	US Guided Single Shot Paravertebral Block US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.	US Guided Paravertebral Catheter US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.	Thoracic Epidural Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
Measure Participants	40	40	40
Median (Inter-Quartile Range) [miligram morphine equivalent]	57	35	21.3

4. Other Pre-specified Outcome

Title	Average Nausea Scores Over 72 Hours
Description	Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as 0=none, 1=mild, 2=moderate, or 3=severe
Time Frame	Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.The scores will then be averaged.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group #1	Group #2	Group #3
Arm/Group Description	US Guided Single Shot Paravertebral Block US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.	US Guided Paravertebral Catheter US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.	Thoracic Epidural Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
Measure Participants	40	40	40
Mean (Full Range) [units on a scale]	0.27	0.27	0.29

5. Other Pre-specified Outcome

Title	Average Sedation Scores Over 72 Hours
Description	Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is 0=awake and alert, 1=quietly awake, 2=asleep and arousable, or 3=deep sleep.
Time Frame	Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group #1	Group #2	Group #3
Arm/Group Description	US Guided Single Shot Paravertebral Block US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.	US Guided Paravertebral Catheter US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.	Thoracic Epidural Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
Measure Participants	40	40	40
Mean (Full Range) [units on a scale]	0.38	0.32	0.22

6. Other Pre-specified Outcome

Title	Subjects Overall Satisfaction Scores
Description	Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. Score was recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.
Time Frame	post operatively at hour 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group #1	Group #2	Group #3
Arm/Group Description	US Guided Single Shot Paravertebral Block US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.	US Guided Paravertebral Catheter US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.	Thoracic Epidural Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
Measure Participants	40	40	40
Mean (Full Range) [units on a scale]	0.89	0.95	1.33

7. Other Pre-specified Outcome

Title	Subjects Overall Satisfaction Scores
Description	Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. Scores will be recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.
Time Frame	post operatively at hour 48

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group #1	Group #2	Group #3
Arm/Group Description	US Guided Single Shot Paravertebral Block US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.	US Guided Paravertebral Catheter US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.	Thoracic Epidural Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
Measure Participants	40	40	40
Mean (Full Range) [units on a scale]	1.19	1.05	1.32

Adverse Events

Time Frame	Participants were followed for 6 months after surgery. Any adverse event from surgery day till 6 months after surgery are documented.
Arm/Group Title	US Guided Single Shot Paravertebral Block		US Guided Paravertebral Catheter		Thoracic Epidural
Arm/Group Description	group 1- US Guided Single Shot Paravertebral Block US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.		group 2- US Guided Paravertebral Catheter US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.		group 3- Thoracic Epidural Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
All Cause Mortality
	US Guided Single Shot Paravertebral Block		US Guided Paravertebral Catheter		Thoracic Epidural
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/40 (0%)
Serious Adverse Events
	US Guided Single Shot Paravertebral Block		US Guided Paravertebral Catheter		Thoracic Epidural
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	US Guided Single Shot Paravertebral Block		US Guided Paravertebral Catheter		Thoracic Epidural
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.