Pain, PostoperativePhase 3NCT03859635

Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures

A Phase 3 study testing Liposomal Bupivacaine, Bupivacaine, 0.25% and Bupivacaine, 0.5% in people with Pain, Postoperative and Thoracic, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Pain, Postoperative, Thoracic, Acute Pain
What is being tested?: Liposomal Bupivacaine, Bupivacaine, 0.25% and Bupivacaine, 0.5%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 7 Feb 2019to 7 Nov 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University Hospital
Indianapolis, Indiana, 46202

Other trials in United States

About this study

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

Read the 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.

Conditions: Pain, Postoperative, Thoracic, Acute Pain
Being tested: Liposomal Bupivacaine, Bupivacaine, 0.25%, Bupivacaine, 0.5%
Keywords: acute pain, VATS
Medical subject headings: Pain, Postoperative, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Liposomal BupivacaineDrug
20 ml
Bupivacaine, 0.25%Drug
10 ml
Bupivacaine, 0.5%Drug
30 ml

Study groups in NCT03859635
Study group	Role	What they receive
Ultrasound guided Liposomal Bupivacaine Erector Spinae Block	Active comparator	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. Receives: Drug: Liposomal Bupivacaine; Drug: Bupivacaine, 0.25%
Ultrasound guided Standard Bupivacaine Erector Spinae Block	Active comparator	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. Receives: Drug: Bupivacaine, 0.5%
Surgeon Infiltration	Active comparator	At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8. Receives: Drug: Liposomal Bupivacaine; Drug: Bupivacaine, 0.25%

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 24 hours pain score at rest
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
Measured: 24 hours pain score with movement
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
Measured: 48 hours pain score at rest
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
Measured: 48 hours pain score with movement

Secondary outcomes (8)

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
Measured: Opioid consumption will be measured at 72 hours post op. The total amount will be recorded.]
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.
Measured: Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged
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
Measured: Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged.]
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
Measured: post operatively at hour 24
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
Measured: post operatively at hour 48
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
Measured: Opioid consumption will be measured at 48 hours post op. The total amount will be recorded.]
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
Measured: Opioid consumption will be measured at 24 hours post op. The total amount will be recorded.]
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
Measured: Opioid consumption will be measured at 1 hour post op. The total amount will be recorded.]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 20197 Nov 2022

First posted1 Mar 2019
Study start7 Feb 2019
Primary completion6 Nov 2022
Study completion7 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03859635
Sponsor's protocol ID: 1809656804
Status last verified: Feb 2025
First submitted: 28 Feb 2019
Last updated: 28 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Bottiger BA, Esper SA, Stafford-Smith M. Pain management strategies for thoracotomy and thoracic pain syndromes. Semin Cardiothorac Vasc Anesth. 2014 Mar;18(1):45-56. doi: 10.1177/1089253213514484. Epub 2013 Dec 12.
PubMed 24336691
Singh S, Chowdhary NK. Erector spinae plane block an effective block for post-operative analgesia in modified radical mastectomy. Indian J Anaesth. 2018 Feb;62(2):148-150. doi: 10.4103/ija.IJA_726_17. No abstract available.
PubMed 29491525
Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
PubMed 29913392
Rao Kadam V, Currie J. Ultrasound-guided continuous erector spinae plane block for postoperative analgesia in video-assisted thoracotomy. Anaesth Intensive Care. 2018 Mar;46(2):243-245. No abstract available.
PubMed 29519230
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016
Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
PubMed 28919152
Taylor R, Massey S, Stuart-Smith K. Postoperative analgesia in video-assisted thoracoscopy: the role of intercostal blockade. J Cardiothorac Vasc Anesth. 2004 Jun;18(3):317-21. doi: 10.1053/j.jvca.2004.03.012.
PubMed 15232812
Wu ZQ, Min JK, Wang D, Yuan YJ, Li H. Liposome bupivacaine for pain control after total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2016 Jul 22;11(1):84. doi: 10.1186/s13018-016-0420-z.
PubMed 27443874
Yu ZX, Yang ZZ, Yao LL. Effectiveness of liposome bupivacaine for postoperative pain control in total knee arthroplasty: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Mar;97(13):e0171. doi: 10.1097/MD.0000000000010171.
PubMed 29595645
Ma TT, Wang YH, Jiang YF, Peng CB, Yan C, Liu ZG, Xu WX. Liposomal bupivacaine versus traditional bupivacaine for pain control after total hip arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(25):e7190. doi: 10.1097/MD.0000000000007190.
PubMed 28640101
Raman S, Lin M, Krishnan N. Systematic review and meta-analysis of the efficacy of liposomal bupivacaine in colorectal resections. J Drug Assess. 2018 Jun 29;7(1):43-50. doi: 10.1080/21556660.2018.1487445. eCollection 2018.
PubMed 29988796
Knudson RA, Dunlavy PW, Franko J, Raman SR, Kraemer SR. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital. Dis Colon Rectum. 2016 Sep;59(9):862-9. doi: 10.1097/DCR.0000000000000648.
PubMed 27505115
Knight RB, Walker PW, Keegan KA, Overholser SM, Baumgartner TS, Ebertowski JS 2nd, Aden JK, White MA. A Randomized Controlled Trial for Pain Control in Laparoscopic Urologic Surgery: 0.25% Bupivacaine Versus Long-Acting Liposomal Bupivacaine. J Endourol. 2015 Sep;29(9):1019-24. doi: 10.1089/end.2014.0769. Epub 2015 Jun 5.
PubMed 25897552
Noviasky J, Pierce DP, Whalen K, Guharoy R, Hildreth K. Bupivacaine liposomal versus bupivacaine: comparative review. Hosp Pharm. 2014 Jun;49(6):539-43. doi: 10.1310/hpj4906-539.
PubMed 24958971
Kaplowitz J, Papadakos PJ. Acute pain management for video-assisted thoracoscopic surgery: an update. J Cardiothorac Vasc Anesth. 2012 Apr;26(2):312-21. doi: 10.1053/j.jvca.2011.04.010. Epub 2011 Jun 25. No abstract available.
PubMed 21705236

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03859635
Acronym / sponsor ID: 1809656804
Conditions: Pain, Postoperative, Thoracic, Acute Pain
Keywords: acute pain, VATS
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: 7 Feb 2019 (actual)
Primary completion: 6 Nov 2022 (actual)
Study completion: 7 Nov 2022 (actual)
First posted: 1 Mar 2019 (actual)
Results: Posted 28 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

All patients will be placed on ERAS protocol, which is our standard of practice.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
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

Arm	Type	Receives
Ultrasound guided Liposomal Bupivacaine Erector Spinae Block	Active comparator	Drug: Liposomal Bupivacaine, Drug: Bupivacaine, 0.25%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.
Ultrasound guided Standard Bupivacaine Erector Spinae Block	Active comparator	Drug: Bupivacaine, 0.5%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.
Surgeon Infiltration	Active comparator	Drug: Liposomal Bupivacaine, Drug: Bupivacaine, 0.25%At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Liposomal Bupivacaine20 ml	Drug	Surgeon Infiltration, Ultrasound guided Liposomal Bupivacaine Erector Spinae Block
Bupivacaine, 0.25%10 ml	Drug	Surgeon Infiltration, Ultrasound guided Liposomal Bupivacaine Erector Spinae Block
Bupivacaine, 0.5%30 ml	Drug	Ultrasound guided Standard Bupivacaine Erector Spinae Block

Primary outcome

The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest
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
The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement
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
The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest
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
The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement
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

8 secondary outcomes

Secondary Endpoint Includes Total Opioid Consumption at 72 Hours
Time frame: Opioid consumption will be measured at 72 hours post op. The total amount will be recorded.]
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
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.]
Subjects Overall Satisfaction Scores at Hour 24
Time frame: post operatively at hour 24
Subjects Overall Satisfaction Scores at Hour 48
Time frame: post operatively at hour 48
Secondary Endpoint Includes Total Opioid Consumption at 48 Hours
Time frame: Opioid consumption will be measured at 48 hours post op. The total amount will be recorded.]
Secondary Endpoint Includes Total Opioid Consumption at 24 Hours
Time frame: Opioid consumption will be measured at 24 hours post op. The total amount will be recorded.]
Secondary Endpoint Includes Total Opioid Consumption at 1 Hour
Time frame: Opioid consumption will be measured at 1 hour post op. The total amount will be recorded.]

Results and safety

Results posted to the registry on 28 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	40	37
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	40	35
Surgeon Infiltration	40	33

Primary outcome: The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest

Time frame: 24 hours pain score at rest. Mean (Standard Deviation). Unit: score on a scale

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n = 37	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n = 35	Surgeon Infiltration n = 33
Value	4.1 (2.5)	4.3 (2.6)	3.3 (2.3)

Primary outcome: The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement

Time frame: 24 hours pain score with movement. Mean (Standard Deviation). Unit: score on a scale

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n = 37	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n = 35	Surgeon Infiltration n = 33
Value	6.0 (2.8)	6.3 (2.3)	4.5 (2.9)

Primary outcome: The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest

Time frame: 48 hours pain score at rest. Mean (Standard Deviation). Unit: score on a scale

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n = 37	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n = 35	Surgeon Infiltration n = 33
Value	3.1 (2.3)	3.4 (2.5)	2.8 (2.1)

Primary outcome: The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement

Time frame: 48 hours pain score with movement. Mean (Standard Deviation). Unit: score on a scale

Measure	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block n = 37	Ultrasound Guided Standard Bupivacaine Erector Spinae Block n = 35	Surgeon Infiltration n = 33
Value	4.6 (2.6)	5.3 (2.4)	3.8 (2.6)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Any adverse events from day of surgery til 6 months after surgery are documented... Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ultrasound Guided Loposomal Erector Spinae Block	0 of 37 (0%)	1 of 37 (2.7%)	0 of 37
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Surgeon Infiltration	0 of 33 (0%)	1 of 33 (3%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24336691Bottiger BA, Esper SA, Stafford-Smith M. Pain management strategies for thoracotomy and thoracic pain syndromes. Semin Cardiothorac Vasc Anesth. 2014 Mar;18(1):45-56. doi: 10.1177/1089253213514484. Epub 2013 Dec 12.
Background: PubMed 29491525Singh S, Chowdhary NK. Erector spinae plane block an effective block for post-operative analgesia in modified radical mastectomy. Indian J Anaesth. 2018 Feb;62(2):148-150. doi: 10.4103/ija.IJA_726_17. No abstract available.
Background: PubMed 29913392Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
Background: PubMed 29519230Rao Kadam V, Currie J. Ultrasound-guided continuous erector spinae plane block for postoperative analgesia in video-assisted thoracotomy. Anaesth Intensive Care. 2018 Mar;46(2):243-245. No abstract available.
Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Background: PubMed 28919152Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
Background: PubMed 15232812Taylor R, Massey S, Stuart-Smith K. Postoperative analgesia in video-assisted thoracoscopy: the role of intercostal blockade. J Cardiothorac Vasc Anesth. 2004 Jun;18(3):317-21. doi: 10.1053/j.jvca.2004.03.012.
Background: PubMed 27443874Wu ZQ, Min JK, Wang D, Yuan YJ, Li H. Liposome bupivacaine for pain control after total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2016 Jul 22;11(1):84. doi: 10.1186/s13018-016-0420-z.
Background: PubMed 29595645Yu ZX, Yang ZZ, Yao LL. Effectiveness of liposome bupivacaine for postoperative pain control in total knee arthroplasty: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Mar;97(13):e0171. doi: 10.1097/MD.0000000000010171.
Background: PubMed 28640101Ma TT, Wang YH, Jiang YF, Peng CB, Yan C, Liu ZG, Xu WX. Liposomal bupivacaine versus traditional bupivacaine for pain control after total hip arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(25):e7190. doi: 10.1097/MD.0000000000007190.
Background: PubMed 29988796Raman S, Lin M, Krishnan N. Systematic review and meta-analysis of the efficacy of liposomal bupivacaine in colorectal resections. J Drug Assess. 2018 Jun 29;7(1):43-50. doi: 10.1080/21556660.2018.1487445. eCollection 2018.
Background: PubMed 27505115Knudson RA, Dunlavy PW, Franko J, Raman SR, Kraemer SR. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital. Dis Colon Rectum. 2016 Sep;59(9):862-9. doi: 10.1097/DCR.0000000000000648.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yar Yeap, MD principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Liposomal Bupivacaine, Bupivacaine, 0.25% and Bupivacaine, 0.5% in people with Pain, Postoperative and Thoracic, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest (time frame: 24 hours pain score at rest). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03859635, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.