CompletedNCT03859635Updated Feb 28, 2025Results posted

Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures

A Phase 3 interventional study of Liposomal Bupivacaine and Bupivacaine, 0.25% in Pain, Postoperative, Thoracic and Acute Pain, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Indiana University · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 120
Allocation: Randomized
Ages: 18 Years to 100 Years
Sex: All

Study 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.

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 studied

Pain, Postoperative
Thoracic
Acute Pain

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Keywords

acute pain
VATS

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 120 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 100 Years
Sexes eligible: 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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 120 participants (actual)

Study arms

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.
Drug: Liposomal Bupivacaine · Drug: Bupivacaine, 0.25%
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.
Drug: Bupivacaine, 0.5%
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.
Drug: Liposomal Bupivacaine · Drug: Bupivacaine, 0.25%

Interventions

DrugLiposomal Bupivacaine
20 ml
DrugBupivacaine, 0.25%
10 ml
DrugBupivacaine, 0.5%
30 ml

What researchers measure

Primary outcomes

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
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
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
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

Secondary outcomes

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.]
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
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.]
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
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
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.]
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.]
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.]

Results

Posted Feb 28, 2025

Participant flow

Participant flow — Overall Study
Milestone	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
Started	40	40	40
Completed	37	35	33
Not completed	3	5	7

Outcome measures

PrimaryThe 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
Reported as:: Mean · score on a scale

The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest
score on a scale	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest	4.1 ± 2.5	4.3 ± 2.6	3.3 ± 2.3

PrimaryThe 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
Reported as:: Mean · score on a scale

The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement
score on a scale	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement	6.0 ± 2.8	6.3 ± 2.3	4.5 ± 2.9

PrimaryThe 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
Reported as:: Mean · score on a scale

The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest
score on a scale	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest	3.1 ± 2.3	3.4 ± 2.5	2.8 ± 2.1

SecondarySecondary 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.]
Reported as:: Median · mg morphine equivalant/day

Secondary Endpoint Includes Total Opioid Consumption at 72 Hours
mg morphine equivalant/day	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
Secondary Endpoint Includes Total Opioid Consumption at 72 Hours	26 (18 to 68)	48 (28 to 72)	40 (20 to 136)

SecondaryAverage 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
Reported as:: Mean · units on a scale

Average Nausea Scores Over 72 Hours
units on a scale	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
Average Nausea Scores Over 72 Hours	0.14 (0 to 3)	0.14 (0 to 2)	0.06 (0 to 2)

SecondaryAverage 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.]
Reported as:: Mean · units on a scale

Average Sedation Scores Over 72 Hours
units on a scale	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
Average Sedation Scores Over 72 Hours	0.08 (0 to 2)	0.03 (0 to 1)	0 (0 to 0)

SecondarySubjects 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
Reported as:: Mean · units on a scale

Subjects Overall Satisfaction Scores at Hour 24
units on a scale	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
Subjects Overall Satisfaction Scores at Hour 24	3.5 (3 to 4)	4 (1 to 4)	3 (2 to 4)

SecondarySubjects 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
Reported as:: Mean · units on a scale

Subjects Overall Satisfaction Scores at Hour 48
units on a scale	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
Subjects Overall Satisfaction Scores at Hour 48	3 (2 to 4)	4 (1 to 4)	4 (1 to 4)

SecondarySecondary 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.]
Reported as:: Median · mg morphine equivalant/day

Secondary Endpoint Includes Total Opioid Consumption at 48 Hours
mg morphine equivalant/day	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
Secondary Endpoint Includes Total Opioid Consumption at 48 Hours	48 (16 to 88)	34 (22 to 76)	60 (28 to 80)

SecondarySecondary 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.]
Reported as:: Median · mg morphine equivalant/day

Secondary Endpoint Includes Total Opioid Consumption at 24 Hours
mg morphine equivalant/day	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
Secondary Endpoint Includes Total Opioid Consumption at 24 Hours	38 (18 to 62)	40 (24 to 96)	36 (20 to 68)

SecondarySecondary 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.]
Reported as:: Median · mg morphine equivalant

Secondary Endpoint Includes Total Opioid Consumption at 1 Hour
mg morphine equivalant	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
Secondary Endpoint Includes Total Opioid Consumption at 1 Hour	16 (8 to 20)	12 (8 to 20)	8 (4 to 16)

PrimaryThe 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
Reported as:: Mean · score on a scale

The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement
score on a scale	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement	4.6 ± 2.6	5.3 ± 2.4	3.8 ± 2.6

Adverse events

Collected over Any adverse events from day of surgery til 6 months after surgery are documented... Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ultrasound Guided Loposomal Erector Spinae Block	0/37 (0%)	0/37 (0%)	1/37 (2.7%)
Ultrasound Guided Standard Bupivacaine Erector Spinae Block	0/35 (0%)	0/35 (0%)	0/35 (0%)
Surgeon Infiltration	0/33 (0%)	0/33 (0%)	1/33 (3%)

Most frequent other events

Most frequent other events
Event	Ultrasound Guided Loposomal Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration
IleusGastrointestinal disorders	1/37	0/35	1/33
Respiratory DepressionRespiratory, thoracic and mediastinal disorders	0/37	0/35	1/33

Baseline characteristics

Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.

Age, Continuous
Age, Continuous(years)	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration	Total
Mean	63 ± 9	64 ± 10	66 ± 12	64 ± 10

Sex: Female, Male
Sex: Female, Male(Participants)	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration	Total
Female	19	26	15	60
Male	18	9	18	45

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration	Total
Count of participants	—	—	—	0

weight
weight(weight in kg)	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration	Total
Mean	76.44 ± 19.02	79.59 ± 16.11	86.19 ± 15.33	80.56 ± 17.29

BMI
BMI(Body Mass Index in kg/m^2)	Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block	Ultrasound Guided Standard Bupivacaine Erector Spinae Block	Surgeon Infiltration	Total
Mean	25.90 ± 5.57	28.81 ± 4.72	29.89 ± 4.89	28.13 ± 5.32

Study locations

1 site

Indiana University Hospital
Indianapolis, Indiana 46202, United States

References and documents

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 ↗

Study documents

Protocol and statistical analysis plan · Feb 28, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03859635
Lead sponsor: Indiana University
Responsible party: Yar Yeap (Assistant Professor of Clinical Anesthesiology. Director, Acute Pain Service, Indiana University) — Principal investigator
First posted: Mar 1, 2019
Start date: Feb 7, 2019
Primary completion: Nov 6, 2022
Completion: Nov 7, 2022
Results posted: Feb 28, 2025
Last update: Feb 28, 2025

Study contacts

Yar Yeap, MD

principal investigator · Indiana University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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