Acute Pain, Pain, Postoperative, Thoracic
Conditions
Keywords
acute pain, VATS
Brief summary
The study is comparing the difference between erector spinae block and surgeon infiltration after VATS (Video Assisted Thoracoscopic Surgery). The outcomes measured are pain scores, opioid usage, opioid side effects, and patient satisfaction.We are also also studying the effectiveness of liposomal bupivacaine (EXPAREL) in a block by randomizing patients to both EXPAREL erector spinae block and simple bupivacaine erector spinae block.
Detailed description
A total of 120 subjects will be randomized by a computer program into three groups (40 per group): The primary investigator will inform the anesthesiologist who will be doing the block as to what group the patients are randomized to. The research staff completing the patients assessments will be blinded to the randomization. For the LB group (Ultrasound guided LB Erector Spinae Plane Block), patients should receive a total of 10ml 0.25% bupivacaine plus 20ml Exparel® (15ml at T4 and 15ml at T8) For the SB group (Ultrasound guided SB Erector Spinae Plane Block), patients should receive a total of 30ml 0.5% bupivacaine. (15ml at T4 and 15ml at T8) For the SI group (under video guidance) injected by surgeon using 10ml 0.25% bupivacaine plus 20ml Exparel All the erector spinae plane blocks will be placed preoperatively after sedation, before intubation and prior to surgery. 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. For the ESP block, an ultrasound probe is used to visualize the ES musculature about 3 cm laterally from the spinous process. In a cephalad-to-caudad direction advance the needle and inject the anesthetic in the interfacial plane deep to the ES muscles. Confirm positioning by visualization of needle tip and elevation of ES muscles off the transverse process with anesthetic injection. Injection will be performed at T4 and T8 level. Surgeon infiltration is performed intraoperatively under direct thoracoscopic guidance. The intercostal space will be visualized and injected with LB. Typically, T4 through T8 are infiltrated with the anesthetic mixture. All patients will be placed on ERAS protocol, which is our standard of practice. Opioid usage 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 surgery. 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
DRUGLiposomal Bupivacaine
20 ml
DRUGBupivacaine, 0.25%
10 ml
DRUGBupivacaine, 0.5%
30 ml
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients are randomized into one of three groups: 1. Ultrasound guided LB Erector Spinae Plane Block with 20ml of Exparel and 10ml 0.25% bupivacaine 2. Ultrasound guided SB Erector Spinae Plane Block with 30ml 0.5% bupivacaine 3. Surgeon Infiltration under video guidance with 20ml of Exparel and 10ml of 0.25% bupivacaine
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Pt undergoing VATS including but not limited to wedge or lobectomy 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 Erector Spinae Plane block * History of substance abuse in the past 6 months which would include heroin, marijuana or any other illegal street drugs * Patient staying intubated after surgery * Patient (home dose) taking more than 30mg PO morphine equivalent per day * Known allergy or other contraindications to the study medications, which include dilaudid and bupivacaine. * Pts. scheduled for a pleurodesis, decortication or esophagectomy at Indiana University Hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest | 24 hours pain score at rest | The VAS score will be taken at rest using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain |
| The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement | 24 hours pain score with movement | The VAS score will be taken after movement (knee flexion) using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain |
| The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest | 48 hours pain score at rest | The VAS score will be taken at rest using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain |
| The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement | 48 hours pain score with movement | The VAS score will be taken after movement (knee flexion) using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Overall Satisfaction Scores at Hour 48 | 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. The scores are collected as Very Unsatisfied=0, Unsatisfied=1, Neutral=2, Satisfied=3, Very Satisfied=4 |
| Secondary Endpoint Includes Total Opioid Consumption at 48 Hours | Opioid consumption will be measured at 48 hours post op. The total amount will be recorded.] | Opioid consumption at 24-48hr post op will be collected by a study team member per protocol time requirements |
| Secondary Endpoint Includes Total Opioid Consumption at 72 Hours | Opioid consumption will be measured at 72 hours post op. The total amount will be recorded.] | Opioid consumption between 48-72hr will be collected by a study team member per protocol time requirements |
| Secondary Endpoint Includes Total Opioid Consumption at 1 Hour | Opioid consumption will be measured at 1 hour post op. The total amount will be recorded.] | Opioid consumption at 1hr will be collected by a study team member per protocol time requirements |
| Secondary Endpoint Includes Total Opioid Consumption at 24 Hours | Opioid consumption will be measured at 24 hours post op. The total amount will be recorded.] | Opioid consumption at 1-24 hr postop will be collected by a study team member per protocol time requirements |
| Average Nausea Scores Over 72 Hours | Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. 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 None=0, Mild=1, Moderate=2, Severe=3. |
| Average Sedation Scores Over 72 Hours | Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. 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 Awake/Alert=0, Quietly Awake=1, Asleep but Arousable=2, or Deep Sleep=3 |
| Subjects Overall Satisfaction Scores at Hour 24 | 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. The scores are collected as Very Unsatisfied=0, Unsatisfied=1, Neutral=2, Satisfied=3, Very Satisfied=4 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. 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.
Liposomal Bupivacaine: 20 ml
Bupivacaine, 0.25%: 10 ml | 37 |
| Ultrasound Guided Standard Bupivacaine Erector Spinae Block All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. 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.
Bupivacaine, 0.5%: 30 ml | 35 |
| Surgeon Infiltration At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.
Liposomal Bupivacaine: 20 ml
Bupivacaine, 0.25%: 10 ml | 33 |
| Total | 105 |
Baseline characteristics
| Characteristic | Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block | Ultrasound Guided Standard Bupivacaine Erector Spinae Block | Surgeon Infiltration | Total |
|---|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 9 | 64 years STANDARD_DEVIATION 10 | 66 years STANDARD_DEVIATION 12 | 64 years STANDARD_DEVIATION 10 |
| BMI | 25.90 Body Mass Index in kg/m^2 STANDARD_DEVIATION 5.57 | 28.81 Body Mass Index in kg/m^2 STANDARD_DEVIATION 4.72 | 29.89 Body Mass Index in kg/m^2 STANDARD_DEVIATION 4.89 | 28.13 Body Mass Index in kg/m^2 STANDARD_DEVIATION 5.32 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 19 Participants | 26 Participants | 15 Participants | 60 Participants |
| Sex: Female, Male Male | 18 Participants | 9 Participants | 18 Participants | 45 Participants |
| weight | 76.44 weight in kg STANDARD_DEVIATION 19.02 | 79.59 weight in kg STANDARD_DEVIATION 16.11 | 86.19 weight in kg STANDARD_DEVIATION 15.33 | 80.56 weight in kg STANDARD_DEVIATION 17.29 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 35 | 0 / 33 |
| other Total, other adverse events | 1 / 37 | 0 / 35 | 1 / 33 |
| serious Total, serious adverse events | 0 / 37 | 0 / 35 | 0 / 33 |
Outcome results
Primary
The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest
The VAS score will be taken at rest using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
Time frame: 24 hours pain score at rest
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block | The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest | 4.1 score on a scale | Standard Deviation 2.5 |
| Ultrasound Guided Standard Bupivacaine Erector Spinae Block | The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest | 4.3 score on a scale | Standard Deviation 2.6 |
| Surgeon Infiltration | The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest | 3.3 score on a scale | Standard Deviation 2.3 |
Primary
The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement
The VAS score will be taken after movement (knee flexion) using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
Time frame: 24 hours pain score with movement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block | The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement | 6.0 score on a scale | Standard Deviation 2.8 |
| Ultrasound Guided Standard Bupivacaine Erector Spinae Block | The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement | 6.3 score on a scale | Standard Deviation 2.3 |
| Surgeon Infiltration | The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement | 4.5 score on a scale | Standard Deviation 2.9 |
Primary
The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest
The VAS score will be taken at rest using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
Time frame: 48 hours pain score at rest
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block | The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest | 3.1 score on a scale | Standard Deviation 2.3 |
| Ultrasound Guided Standard Bupivacaine Erector Spinae Block | The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest | 3.4 score on a scale | Standard Deviation 2.5 |
| Surgeon Infiltration | The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest | 2.8 score on a scale | Standard Deviation 2.1 |
Primary
The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement
The VAS score will be taken after movement (knee flexion) using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
Time frame: 48 hours pain score with movement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block | The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement | 4.6 score on a scale | Standard Deviation 2.6 |
| Ultrasound Guided Standard Bupivacaine Erector Spinae Block | The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement | 5.3 score on a scale | Standard Deviation 2.4 |
| Surgeon Infiltration | The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement | 3.8 score on a scale | Standard Deviation 2.6 |
Secondary
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 None=0, Mild=1, Moderate=2, Severe=3.
Time frame: Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged
Population: Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block | Average Nausea Scores Over 72 Hours | 0.14 units on a scale |
| Ultrasound Guided Standard Bupivacaine Erector Spinae Block | Average Nausea Scores Over 72 Hours | 0.14 units on a scale |
| Surgeon Infiltration | Average Nausea Scores Over 72 Hours | 0.06 units on a scale |
Secondary
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 Awake/Alert=0, Quietly Awake=1, Asleep but Arousable=2, or Deep Sleep=3
Time frame: Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged.]
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block | Average Sedation Scores Over 72 Hours | 0.08 units on a scale |
| Ultrasound Guided Standard Bupivacaine Erector Spinae Block | Average Sedation Scores Over 72 Hours | 0.03 units on a scale |
| Surgeon Infiltration | Average Sedation Scores Over 72 Hours | 0 units on a scale |
Secondary
Secondary Endpoint Includes Total Opioid Consumption at 1 Hour
Opioid consumption at 1hr will be collected by a study team member per protocol time requirements
Time frame: Opioid consumption will be measured at 1 hour post op. The total amount will be recorded.]
Population: Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block | Secondary Endpoint Includes Total Opioid Consumption at 1 Hour | 16 mg morphine equivalant |
| Ultrasound Guided Standard Bupivacaine Erector Spinae Block | Secondary Endpoint Includes Total Opioid Consumption at 1 Hour | 12 mg morphine equivalant |
| Surgeon Infiltration | Secondary Endpoint Includes Total Opioid Consumption at 1 Hour | 8 mg morphine equivalant |
Secondary
Secondary Endpoint Includes Total Opioid Consumption at 24 Hours
Opioid consumption at 1-24 hr postop will be collected by a study team member per protocol time requirements
Time frame: Opioid consumption will be measured at 24 hours post op. The total amount will be recorded.]
Population: Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block | Secondary Endpoint Includes Total Opioid Consumption at 24 Hours | 38 mg morphine equivalant/day |
| Ultrasound Guided Standard Bupivacaine Erector Spinae Block | Secondary Endpoint Includes Total Opioid Consumption at 24 Hours | 40 mg morphine equivalant/day |
| Surgeon Infiltration | Secondary Endpoint Includes Total Opioid Consumption at 24 Hours | 36 mg morphine equivalant/day |
Secondary
Secondary Endpoint Includes Total Opioid Consumption at 48 Hours
Opioid consumption at 24-48hr post op will be collected by a study team member per protocol time requirements
Time frame: Opioid consumption will be measured at 48 hours post op. The total amount will be recorded.]
Population: Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block | Secondary Endpoint Includes Total Opioid Consumption at 48 Hours | 48 mg morphine equivalant/day |
| Ultrasound Guided Standard Bupivacaine Erector Spinae Block | Secondary Endpoint Includes Total Opioid Consumption at 48 Hours | 34 mg morphine equivalant/day |
| Surgeon Infiltration | Secondary Endpoint Includes Total Opioid Consumption at 48 Hours | 60 mg morphine equivalant/day |
Secondary
Secondary Endpoint Includes Total Opioid Consumption at 72 Hours
Opioid consumption between 48-72hr will be collected by a study team member per protocol time requirements
Time frame: Opioid consumption will be measured at 72 hours post op. The total amount will be recorded.]
Population: Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block | Secondary Endpoint Includes Total Opioid Consumption at 72 Hours | 26 mg morphine equivalant/day |
| Ultrasound Guided Standard Bupivacaine Erector Spinae Block | Secondary Endpoint Includes Total Opioid Consumption at 72 Hours | 48 mg morphine equivalant/day |
| Surgeon Infiltration | Secondary Endpoint Includes Total Opioid Consumption at 72 Hours | 40 mg morphine equivalant/day |
Secondary
Subjects Overall Satisfaction Scores at Hour 24
Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. The scores are collected as Very Unsatisfied=0, Unsatisfied=1, Neutral=2, Satisfied=3, Very Satisfied=4
Time frame: post operatively at hour 24
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block | Subjects Overall Satisfaction Scores at Hour 24 | 3.5 units on a scale |
| Ultrasound Guided Standard Bupivacaine Erector Spinae Block | Subjects Overall Satisfaction Scores at Hour 24 | 4 units on a scale |
| Surgeon Infiltration | Subjects Overall Satisfaction Scores at Hour 24 | 3 units on a scale |
Secondary
Subjects Overall Satisfaction Scores at Hour 48
Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. The scores are collected as Very Unsatisfied=0, Unsatisfied=1, Neutral=2, Satisfied=3, Very Satisfied=4
Time frame: post operatively at hour 48
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block | Subjects Overall Satisfaction Scores at Hour 48 | 3 units on a scale |
| Ultrasound Guided Standard Bupivacaine Erector Spinae Block | Subjects Overall Satisfaction Scores at Hour 48 | 4 units on a scale |
| Surgeon Infiltration | Subjects Overall Satisfaction Scores at Hour 48 | 4 units on a scale |