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CompletedNCT03587584RCRUpdated Jul 27, 2022Results posted

Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair

A Phase 4 interventional study of liposomal bupivacaine and Bupivacaine in Acute Pain, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-27.

Sponsored by University of Minnesota · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare pain control after arthroscopic rotator cuff repair surgery using either liposomal bupivacaine or bupivacaine when injected in an interscalene block. Both medications, liposomal bupivacaine and bupivacaine, are standard of care in these types of surgeries.

Read the detailed description

All patients will receive preoperative oral multimodal medications consisting of acetaminophen 975 mg, gabapentin 300 mg, and Celebrex 400 mg.

After completion of the preoperative process the patient will be placed in the supine position with the head of the bed elevated 30 degrees with standard ASA monitors applied. Sedation will be provided with midazolam 0-2 mg and propofol 50 mg. The interscalene groove will be identified with the ultrasound. Using sterile technique, a 21g Nerve block needle will then be inserted and advanced under ultrasound guidance until it is in the interscalene groove. Once in the interscalene, 20 mL of local anesthetic will be injected, with 10 mL deposited at the top of the brachial plexus and 10 mL at the bottom. In the study group, 5 mL of each 0.5% bupivacaine and LB will be injected at each location. The control group with have 20 mL of 0.5% bupivacaine divided between the injection sites. The patient will be monitored in the preoperative area until he/she is brought into the operating room for their procedure. A working block prior to surgery will be confirmed via sensory testing of the shoulder.

All patients will undergo a standard induction with propofol 1.5-3.0 mg/kg, ondansetron 4 mg, dexamethasone 10 mg and ketamine 0.25 mg/kg. A MAC or general with LMA or ETT will be placed and an opioid sparing technique will occur. Standardized maintenance will be a propofol infusion without neuromuscular blockers. 25-50 mcg of IV Fentanyl will be utilized for increases in heart rate greater than 20% or increases in systolic blood pressure above baseline.

Once in the operating room the surgeon will use 10 mL of 0.25% bupivacaine for skin, subcutaneous, and intraarticular injection.

When the operation is complete, the patient will be woken up and brought to the PACU. There the patient will receive IV fentanyl for a pain score of greater than 7. If more than 100 mcg of fentanyl is given and pain still remains above a 7 then IV hydromorphone will be used. A dose of 5-10 mg of oral oxycodone (or 2-4 mg of oral hydromorphone) will be given as soon as the patient is able to tolerate oral medication per standard protocol: If their pain score is 4-6 (on the Visual Analog Scale) then 5mg oral oxycodone (2 mg hydromorphone) can be administered, if their pain is between 7 to 10 then 10 mg of oxycodone (or 4 mg of hydromorphone) can be administered. Once the patient meets discharge criteria, they will be discharged home where each day they will fill out a pain diary. Additionally, a member of the research team will call the patient for signs of complications and ask the patient their current pain score, total opioid pills taken and non-opioid pain medication taken at 24, 48, and 72 hours postoperatively. Additionally, they will perform a Quality of Recovery Score survey at 72 hours, and 14 days postoperatively. An Ultrasound of the diaphragm will be completed by a blinded anesthesiologist in the PACU to assess diaphragm function.

All patients will be discharged with acetaminophen 975 mg q6 hours \& ibuprofen 600 mg q6 hours, taken in intervals such that the patient is taking one of these medications every 3 hours. And then hydromorphone 2mg pills #60 dosing 1-2 pills q4 hours prn severe pain or oxycodone 5 mg pills #60 dosing 1-2 pills q 4 hours prn severe pain.

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Conditions studied

  • Acute Pain

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In context

Acute Pain

876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.

This study's enrollment of 80 is below the median of 90 across 732 interventional studies indexed under Acute Pain.

Browse Acute Pain studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients aged greater than 18 years of age that are undergoing arthroscopic rotator cuff surgery

Exclusion criteria

Exclusion Criteria:

  • Patients with allergy to local anesthetics
  • Patients with daily use of opioids for more than 3 weeks prior to surgery
  • Patients who refuse
  • Patients with coagulopathy
  • Patients who are non-english speaking
  • Patients who do not have access to a telephone
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    liposomal bupivacaine

    These patients receive an interscalene block with liposomal bupivacaine.

    Drug: liposomal bupivacaine

  • Active comparator
    bupivacaine

    These patients receive an interscalene block with bupivacaine.

    Drug: Bupivacaine

Interventions

  • Drugliposomal bupivacaine

    Experimental

  • DrugBupivacaine

    Active Comparator

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What researchers measure

Primary outcomes

  1. Total Intraoperative Opioids Used

    Total amount of opioid medications used during surgery. Opioids normalized to total morphine equivalents.

    Time frame: through end of surgery

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Results

Posted Jul 27, 2022

Participant flow

Participant flow — Overall Study
MilestoneLiposomal BupivacaineBupivacaine
Started3742
Completed3333
Not completed49
Withdrew: Soc deviations46
Withdrew: Incomplete data03

Outcome measures

PrimaryTotal Intraoperative Opioids Used

Total amount of opioid medications used during surgery. Opioids normalized to total morphine equivalents.

Time frame:
through end of surgery
Reported as:
Median · mg
Total Intraoperative Opioids Used
mgLiposomal BupivacaineBupivacaine
Intraoperative Fentanyl (mg).1 (.1 to .1).1 (.05 to .1)
Intraoperative MME (mg)30 (30 to 30)30 (15 to 30)
Intraoperative hydromorphone (mg)0 (0 to 0)0 (0 to 0)
Intraoperative ketamine0 (0 to 0)0 (0 to 0)
Intraoperative ketorolac (mg)0 (0 to 30)0 (0 to 30)

Adverse events

Collected over 72 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Liposomal Bupivacaine0/33 (0%)0/33 (0%)6/33 (18.2%)
Bupivacaine0/33 (0%)0/33 (0%)6/33 (18.2%)
Most frequent other events
Most frequent other events
EventLiposomal BupivacaineBupivacaine
NauseaGastrointestinal disorders5/334/33
VomitingGastrointestinal disorders1/332/33

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Liposomal BupivacaineBupivacaineTotal
<=18 years000
Between 18 and 65 years303666
>=65 years7613
Sex: Female, Male
Sex: Female, Male(Participants)Liposomal BupivacaineBupivacaineTotal
Female222648
Male151631
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Liposomal BupivacaineBupivacaineTotal
Count of participants——0
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Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
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References and documents

Publications

  • Flaherty JM, Berg AA, Harrison A, Braman J, Pearson JM, Matelich B, Kaizer AM, Hutchins JL. Comparing liposomal bupivacaine plus bupivacaine to bupivacaine alone in interscalene blocks for rotator cuff repair surgery: a randomized clinical trial. Reg Anesth Pain Med. 2022 May;47(5):309-312. doi: 10.1136/rapm-2021-103349. Epub 2022 Feb 21. PubMed 35190468 ↗

Study documents

  • Protocol and statistical analysis plan · May 11, 2020
  • Informed consent form · May 11, 2020

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

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03587584
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jul 16, 2018
Start date
Jul 25, 2018
Primary completion
May 25, 2021
Completion
Jun 8, 2021
Results posted
Jul 27, 2022
Last update
Jul 27, 2022

Study contacts

Tenzin Desa
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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