Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures
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| ClinicalTrials.gov Identifier: NCT03859635 |
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Recruitment Status :
Recruiting
First Posted : March 1, 2019
Last Update Posted : November 30, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain, Postoperative Thoracic Acute Pain | Drug: Liposomal Bupivacaine Drug: Bupivacaine, 0.25% Drug: Bupivacaine, 0.5% | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Patients are randomized into one of three groups:
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| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Prospective Study Comparing Exparel Erector Spinae Plane Block vs Simple Bupivacaine Erector Spinae Plane Block vs Exparel Surgeon Infiltration for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery |
| Actual Study Start Date : | February 7, 2019 |
| Estimated Primary Completion Date : | June 30, 2021 |
| Estimated Study Completion Date : | August 30, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 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.
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Drug: Liposomal Bupivacaine
20 ml Drug: Bupivacaine, 0.25% 10 ml |
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Active Comparator: 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.
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Drug: Bupivacaine, 0.5%
30 ml |
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Active Comparator: Surgeon Infiltration
At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.
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Drug: Liposomal Bupivacaine
20 ml Drug: Bupivacaine, 0.25% 10 ml |
- The Primary endpoint of this study will be VAS pain score at 24 hours [ Time Frame: 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 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 [ Time Frame: Pain scores will be measured 48 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 a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
- Secondary endpoint includes total opioid consumption at 72 hours [ 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.] ]Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements
- Average Nausea scores over 72 hours [ 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 ]Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe
- Average Sedation scores over 72 hours [ 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.] ]Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake and alert, quietly awake, asleep and arousable, or deep sleep.
- Subjects overall satisfaction scores at hour 24 [ Time Frame: 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
- Subjects overall satisfaction scores at hour 48 [ Time Frame: post operatively at hour 48 ]Subjects will be followed up at 48 hours post operatively by a study team
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859635
| Contact: Angie Plummer, LPN | 317-944-7239 | plummera@iupui.edu | |
| Contact: Lyla S Farlow, LPN | 317-948-9804 | lychrist@iupui.edu |
| United States, Indiana | |
| Indiana University Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Yar Yeap, MD 317-274-0275 yyeap@iupui.edu | |
| Contact: Angie m Plummer, LPN CCRP 317-274-0277 plummera@iupui.edu | |
| Principal Investigator: | Yar Yeap, MD | Indiana University |
Other Publications:
| Responsible Party: | Yar Yeap, Assistant Professor of Clinical Anesthesiology. Director, Acute Pain Service, Indiana University |
| ClinicalTrials.gov Identifier: | NCT03859635 |
| Other Study ID Numbers: |
1809656804 |
| First Posted: | March 1, 2019 Key Record Dates |
| Last Update Posted: | November 30, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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acute pain VATS |
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Pain, Postoperative Acute Pain Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Bupivacaine |
Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |