Liposomal Bupivacaine in Rotator Cuff Repair

Efficacy of Liposomal Bupivacaine in Arthroscopic Rotator Cuff Repair

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03738696

Enrollment

Registered

2018-11-13

Start date

2019-12-15

Completion date

2022-01-01

Last updated

2024-05-16

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

Conditions

Rotator Cuff Injury

Brief summary

To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.

Interventions

DRUGExparel

A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain

DRUGRopivacaine

A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Undergoing outpatient arthroscopic rotator cuff repair * Greater than or equal to 19 years of age at the time of surgery

Exclusion criteria

* Planned operative fixation of the biceps tendon or acromioclavicular joint * Opioid use 6 weeks before surgery * Gabapentin use 6 weeks before surgery * History of prior shoulder surgery on the operative limb * Severe pulmonary dysfunction * Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s) * History of radicular pain or neuropathy in the operative limb * Patients who are currently incapacitated for medical decision making

Design outcomes

Primary

Measure	Time frame	Description
Average Postoperative Pain Scores Over a 96 Hour Timeframe	Up to 96 hrs postoperative	Visual analog pain scores after operation \[0-10, with 10 being the worst pain\]

Secondary

Measure	Time frame	Description
Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe	Up to 96 hrs	oral morphine equivalents of all opioid-containing medications received
Average Analgesia Satisfaction Over a 96 Hour Timeframe	Up to 96 hrs	Likert scale of analgesia satisfaction \[0-5, with 5 being the most satisfied\]
Percentage of Participants With Analgesia Complications	Up to 96 hrs	Complications resulting from the method of analgesia utilized
Average Sleep Quality Over a 96 Hour Timeframe	Up to 96 hrs postoperative	Scale of sleep quality \[0-10, with 10 being the most satisfied\]
Average Hours of Painless Sleep	Up to 96 hrs postoperative	Hours of sleep uninterrupted by pain \[numerical, hours\]

Countries

United States

Participant flow

Participants by arm

Arm	Count
Liposomal Bupivacaine Block 10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain	28
Ropivacaine Interscalene Catheter * bolus of 15-20 mL of 0.5% ropivacaine given through the needle prior to threading the catheter * 0.2% ropivacaine started in the post-anesthesia care unit at 8 mL/hour for 48 hours Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain	35
Total	63

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	8	14
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Liposomal Bupivacaine Block	Ropivacaine Interscalene Catheter	Total
Age, Continuous	56.5 years STANDARD_DEVIATION 12.9	54.2 years STANDARD_DEVIATION 13	55.2 years STANDARD_DEVIATION 12.9
Body Mass Index	31.8 kg/m2 STANDARD_DEVIATION 6.8	33.0 kg/m2 STANDARD_DEVIATION 5.8	32.5 kg/m2 STANDARD_DEVIATION 6.2
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment United States	28 participants	35 participants	63 participants
Sex: Female, Male Female	11 Participants	14 Participants	25 Participants
Sex: Female, Male Male	17 Participants	21 Participants	38 Participants
Tobacco Use	7 participants	9 participants	16 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 28	0 / 33
other Total, other adverse events	8 / 28	12 / 33
serious Total, serious adverse events	0 / 28	0 / 33

Outcome results

Primary