Pain, Acute, Pain, Postoperative, Video Assisted Thoracoscopic Surgery
Conditions
Keywords
VATS, pain
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.
Interventions
Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
Epidural catheter will be placed in the thoracic region prior to surgery.
Sponsors
Study design
Intervention model description
Patients randomized to epidural, single shot paravertebral block, and paravertebral catheter
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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). Usingunits on a scale scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| US Guided Single Shot Paravertebral Block 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. | 40 |
| US Guided Paravertebral Catheter 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. | 40 |
| Thoracic Epidural group 3- Thoracic Epidural
Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery. | 40 |
| Total | 120 |
Baseline characteristics
| Characteristic | US Guided Single Shot Paravertebral Block | Total | Thoracic Epidural | US Guided Paravertebral Catheter |
|---|---|---|---|---|
| Age, Continuous | 63.5 years | 62 years | 61 years | 62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 40 Participants | 120 Participants | 40 Participants | 40 Participants |
| height | 171 Centimeter | 170 Centimeter | 173.5 Centimeter | 167.6 Centimeter |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 13 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 32 Participants | 104 Participants | 39 Participants | 33 Participants |
| Region of Enrollment United States | 40 Participants | 120 Participants | 40 Participants | 40 Participants |
| Sex: Female, Male Female | 24 Participants | 60 Participants | 15 Participants | 21 Participants |
| Sex: Female, Male Male | 16 Participants | 60 Participants | 25 Participants | 19 Participants |
| weight | 88.4 Kilogram | 84.1 Kilogram | 87.3 Kilogram | 77.7 Kilogram |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
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
Time frame: Pain scores will be measured 24 hours after surgery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| US Guided Single Shot Paravertebral Block | The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours | 4.0 units on a scale |
| US Guided Paravertebral Catheter | The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours | 4.5 units on a scale |
| Thoracic Epidural | The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours | 3.0 units on a scale |
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
Time frame: Pain scores will be measured 48 hours after surgery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| US Guided Single Shot Paravertebral Block | The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours | 3.0 units on a scale |
| US Guided Paravertebral Catheter | The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours | 4.0 units on a scale |
| Thoracic Epidural | The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours | 2.0 units on a scale |
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
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| US Guided Single Shot Paravertebral Block | Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours | 57 miligram morphine equivalent |
| US Guided Paravertebral Catheter | Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours | 35 miligram morphine equivalent |
| Thoracic Epidural | Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours | 21.3 miligram morphine equivalent |
Average Nausea Scores Over 72 Hours
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| US Guided Single Shot Paravertebral Block | Average Nausea Scores Over 72 Hours | 0.27 units on a scale |
| US Guided Paravertebral Catheter | Average Nausea Scores Over 72 Hours | 0.27 units on a scale |
| Thoracic Epidural | Average Nausea Scores Over 72 Hours | 0.29 units on a scale |
Average Sedation Scores Over 72 Hours
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| US Guided Single Shot Paravertebral Block | Average Sedation Scores Over 72 Hours | 0.38 units on a scale |
| US Guided Paravertebral Catheter | Average Sedation Scores Over 72 Hours | 0.32 units on a scale |
| Thoracic Epidural | Average Sedation Scores Over 72 Hours | 0.22 units on a scale |
Subjects Overall Satisfaction Scores
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| US Guided Single Shot Paravertebral Block | Subjects Overall Satisfaction Scores | 0.89 units on a scale |
| US Guided Paravertebral Catheter | Subjects Overall Satisfaction Scores | 0.95 units on a scale |
| Thoracic Epidural | Subjects Overall Satisfaction Scores | 1.33 units on a scale |
Subjects Overall Satisfaction Scores
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| US Guided Single Shot Paravertebral Block | Subjects Overall Satisfaction Scores | 1.19 units on a scale |
| US Guided Paravertebral Catheter | Subjects Overall Satisfaction Scores | 1.05 units on a scale |
| Thoracic Epidural | Subjects Overall Satisfaction Scores | 1.32 units on a scale |