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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Prospective Study Comparing Paravertebral Catheters, Single Shot Paravertebral Block, Thoracic Epidural, for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery

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

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients randomized to epidural, single shot paravertebral block, and paravertebral catheter
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). Usingunits 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VATS, pain