Skip to content

Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair

Comparing Liposomal Bupivacaine to Bupivacaine Interscalene Blocks for Arthroscopic Rotator Cuff Repair Surgery: A Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03587584
Acronym
RCR
Enrollment
80
Registered
2018-07-16
Start date
2018-07-25
Completion date
2021-06-08
Last updated
2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Brief 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.

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.

Interventions

DRUGliposomal bupivacaine

Experimental

DRUGBupivacaine

Active Comparator

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Total Intraoperative Opioids Usedthrough end of surgeryTotal amount of opioid medications used during surgery. Opioids normalized to total morphine equivalents.

Countries

United States

Participant flow

Participants by arm

ArmCount
Liposomal Bupivacaine
These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental
37
Bupivacaine
These patients receive an interscalene block with bupivacaine. Bupivacaine: Active Comparator
42
Total79

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyIncomplete data03
Overall StudySOC deviations46

Baseline characteristics

CharacteristicLiposomal BupivacaineBupivacaineTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
7 Participants6 Participants13 Participants
Age, Categorical
Between 18 and 65 years
30 Participants36 Participants66 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
22 Participants26 Participants48 Participants
Sex: Female, Male
Male
15 Participants16 Participants31 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 330 / 33
other
Total, other adverse events
6 / 336 / 33
serious
Total, serious adverse events
0 / 330 / 33

Outcome results

Primary

Total Intraoperative Opioids Used

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

Time frame: through end of surgery

ArmMeasureGroupValue (MEDIAN)
Liposomal BupivacaineTotal Intraoperative Opioids UsedIntraoperative MME (mg)30 mg
Liposomal BupivacaineTotal Intraoperative Opioids UsedIntraoperative ketamine0 mg
Liposomal BupivacaineTotal Intraoperative Opioids UsedIntraoperative hydromorphone (mg)0 mg
Liposomal BupivacaineTotal Intraoperative Opioids UsedIntraoperative ketorolac (mg)0 mg
Liposomal BupivacaineTotal Intraoperative Opioids UsedIntraoperative Fentanyl (mg).1 mg
BupivacaineTotal Intraoperative Opioids UsedIntraoperative ketorolac (mg)0 mg
BupivacaineTotal Intraoperative Opioids UsedIntraoperative Fentanyl (mg).1 mg
BupivacaineTotal Intraoperative Opioids UsedIntraoperative MME (mg)30 mg
BupivacaineTotal Intraoperative Opioids UsedIntraoperative hydromorphone (mg)0 mg
BupivacaineTotal Intraoperative Opioids UsedIntraoperative ketamine0 mg

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026