Indiana University Hospital
Indianapolis, Indiana, 46202, United States
NCT Number: NCT03859635
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.
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Notify Me18 year–100 year
All sexes
Interventional
Phase 3
Indianapolis, Indiana, 46202, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
20 ml
10 ml
30 ml
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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=0, Mild=1, Moderate=2, Severe=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.]
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: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Indiana University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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