NCT03887650 is a Phase 4 clinical trial of Liposomal Bupivicaine 1.3% in Post-operative Pain, sponsored by Hartford Hospital.

Who is sponsoring NCT03887650?

NCT03887650 is sponsored by Hartford Hospital.

What drugs are being tested in NCT03887650?

Interventions in NCT03887650: Liposomal Bupivicaine 1.3%, Bupivacaine 0.5%.

What condition does NCT03887650 study?

NCT03887650 studies Post-operative Pain, Total Shoulder Arthroplasty, Osteoarthritis of the Shoulder, Pain Management.

Is NCT03887650 still recruiting?

NCT03887650 is currently completed. Last updated 15 September 2023.

Are results published for NCT03887650?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-09-15 · How we verify

NCT03887650

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs

Completed Phase 4 Results posted Last updated 15 September 2023

What this trial tests

Phase 4 trial testing Liposomal Bupivicaine 1.3% in Post-operative Pain in 90 participants. Completed in 8 March 2022.

Timeline

11 March 2019

Primary endpoint
11 January 2022

8 March 2022

Quick facts

Lead sponsor	Hartford Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	90
Start date	11 March 2019
Primary completion	11 January 2022
Estimated completion	8 March 2022
Sites	1 location across United States

Drugs / interventions tested

Liposomal Bupivicaine 1.3% — full drug profile →
Bupivacaine 0.5% — full drug profile →

Conditions studied

Post-operative Pain — all drugs for Post-operative Pain →
Total Shoulder Arthroplasty — all drugs for Total Shoulder Arthroplasty →
Osteoarthritis of the Shoulder — all drugs for Osteoarthritis of the Shoulder →
Pain Management — all drugs for Pain Management →

Sponsor

Hartford Hospital

Who can join

Adults 18 to 100, any sex, with Post-operative Pain or Total Shoulder Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Opioid Consumption Primary · Up to 120 postoperative hours

Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	71.25	43.00 – 120.00
Bupivacaine 0.5% With Adjuncts	90.30	57.37 – 133.43

Time to First Opioid Medication Secondary · from the time of the block injection until discharge, assessed up to 72 postoperative hours.

From block time to the first dose of opioids given, measured in hours.

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	10.5667	5.800 – 20.850
Bupivacaine 0.5% With Adjuncts	12.025	4.404 – 21.983

Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours Secondary · 24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60

Pain assessment is categorized as minimum, maximum, and average pain scores reported by patients using questions from the Modified Brief Pain Inventory-short form (MBPI-SF) during the following intervals; PACU-24, 24-48, 48-72, and 72-96 postoperative hours, and at day 60. This form collected minimum, maximum, and average on a numeric pain scale (0-10) where 0 is no pain and 10 is the worst pain.

PACU

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	0.00	0.00 – 1.00
Bupivacaine 0.5% With Adjuncts	0.00	0.00 – 1.50

PACU-24 hours Minimum

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	0.00	0.00 – 1.00
Bupivacaine 0.5% With Adjuncts	0.00	0.00 – 0.00

PACU-24 hours Maximum

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	2.00	0.00 – 4.50
Bupivacaine 0.5% With Adjuncts	1.00	0.00 – 4.50

PACU-24 hours Average

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	1.00	0.00 – 2.00
Bupivacaine 0.5% With Adjuncts	0.00	0.00 – 3.50

24-48 hours Minimum

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	0.00	0.00 – 2.00
Bupivacaine 0.5% With Adjuncts	2.00	0.00 – 3.75

24-48 hours Maximum

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	4.50	1.00 – 6.00
Bupivacaine 0.5% With Adjuncts	7.00	5.00 – 8.00

24-48 hours Average

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	2.00	0.00 – 3.75
Bupivacaine 0.5% With Adjuncts	4.00	3.00 – 5.00

48-72 hours Minimum

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	1.00	0.00 – 2.00
Bupivacaine 0.5% With Adjuncts	2.00	1.00 – 3.00

Hospital Length-of-stay Secondary · From the date of admission until discharge, assessed up to 72 hours.

From the date and time of admission to the date and time of discharge, Measured in hours.

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	31.05	29.67 – 32.53
Bupivacaine 0.5% With Adjuncts	31.63	30.63 – 36.58

Assessment of Patient Overall Satisfaction With Pain Control Secondary · POD4 - 60 days

Patient overall satisfaction with pain control was assessed two times; on the fourth and the 60th postoperative days. It was assessed using a numeric scale (0-10) where 0 is very dissatisfied while 10 is extremely satisfied. The results indicated only the percentage of participants who reported a 10/10 satisfaction rate.

POD4

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	32
Bupivacaine 0.5% With Adjuncts	24
Liposomal Bupivacaine 1.3%	9
Bupivacaine 0.5% With Adjuncts	17
Liposomal Bupivacaine 1.3%	4
Bupivacaine 0.5% With Adjuncts	1

POD60

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	27
Bupivacaine 0.5% With Adjuncts	28
Liposomal Bupivacaine 1.3%	12
Bupivacaine 0.5% With Adjuncts	13
Liposomal Bupivacaine 1.3%	5
Bupivacaine 0.5% With Adjuncts	1

Incidence of Distress From Block Numbness Secondary · At PACU and Postoperative day 2

On a distress scale of (0 -10) with 0 = not at all and 10 = very much distressed, the scores were gathered and the results are grouped to show the percentage of either the presence of distress (any positive score) or no distress, assessed at two times; at the PACU and the second postoperative day.

PACU distress

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	31
Bupivacaine 0.5% With Adjuncts	31
Liposomal Bupivacaine 1.3%	14
Bupivacaine 0.5% With Adjuncts	14
Liposomal Bupivacaine 1.3%	0
Bupivacaine 0.5% With Adjuncts	0

POD2 Distress

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	32
Bupivacaine 0.5% With Adjuncts	31
Liposomal Bupivacaine 1.3%	12
Bupivacaine 0.5% With Adjuncts	12
Liposomal Bupivacaine 1.3%	1
Bupivacaine 0.5% With Adjuncts	2

Duration of Sensory Nerve Block Secondary · Day 1, after Day 1 (day 2 to 60), and at postoperative day 60

Using the sensory assessment test, the results show the percentage of participants who had the return of first sensation and full sensation either on Day 1, after Day 1 (day 2 to 60), and at postoperative day 60.

Full sensation

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	11
Bupivacaine 0.5% With Adjuncts	11
Liposomal Bupivacaine 1.3%	27
Bupivacaine 0.5% With Adjuncts	27
Liposomal Bupivacaine 1.3%	0
Bupivacaine 0.5% With Adjuncts	2
Liposomal Bupivacaine 1.3%	7
Bupivacaine 0.5% With Adjuncts	5

First sensation

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	35
Bupivacaine 0.5% With Adjuncts	33
Liposomal Bupivacaine 1.3%	9
Bupivacaine 0.5% With Adjuncts	10
Liposomal Bupivacaine 1.3%	0
Bupivacaine 0.5% With Adjuncts	0
Liposomal Bupivacaine 1.3%	1
Bupivacaine 0.5% With Adjuncts	2

Day of the Final Opioids Used Secondary · 0-96 postoperative hours

The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours.

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	4	1.5 – 4
Bupivacaine 0.5% With Adjuncts	4	1 – 4

Motor Recovery Secondary · PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.

The Motor function was assessed by shoulder abduction and elbow flexion using the Oxford scale of muscle strength grading (Muscle Grading Scores 0-5): 0= No detectable muscle contraction (visible or palpation) 1. Detectable contraction (visible or palpation), but no movement achieved 2. Limb movement achieved, but unable to move against gravity 3. Limb movement against the resistance of gravity 4. Limb movement against gravity and external resistance 5. Normal strength The results were grouped to show the return of any movement at the PACU, Day 1, after Day 1 (day2-60), and on day 60. And t

Any movement in PACU

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	1
Bupivacaine 0.5% With Adjuncts	11

Any movement in day1

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	4
Bupivacaine 0.5% With Adjuncts	3

Any movement after day1

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	38
Bupivacaine 0.5% With Adjuncts	29

Any movement missing data

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	2
Bupivacaine 0.5% With Adjuncts	2

Return of full movement day 2-60

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	32
Bupivacaine 0.5% With Adjuncts	31

Not yet by day 60

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	3
Bupivacaine 0.5% With Adjuncts	6

Return of full movement missing data

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	10
Bupivacaine 0.5% With Adjuncts	8

Total Amount of Opioid Consumed During the Indicated Time Periods Secondary · 0-24, 24-48, 48-72, and 72-120 postoperative hours.

Opioid use was calculated using the Morphine MilliEquevalent per day, this was assessed daily during the postoperative period, 0-24, 24-48, 48-72, and 72-120 postoperative hours.

0-24 hours

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	25.00	25.00 – 39.37
Bupivacaine 0.5% With Adjuncts	25.00	25.00 – 37.50

24-48 hours

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	16.00	0.00 – 38.75
Bupivacaine 0.5% With Adjuncts	23.25	9.75 – 39.37

48-72 hours

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	2.00	0.00 – 8.00
Bupivacaine 0.5% With Adjuncts	5.00	0.00 – 15.00

72-120 hours

Group	Value	95% CI
Liposomal Bupivacaine 1.3%	10.00	0.00 – 27.00
Bupivacaine 0.5% With Adjuncts	15.00	0.00 – 37.50

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected up to 60 postoperative days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Liposomal Bupivacaine 1.3%

Serious: 0/45 (0%)

Deaths: 0/45

Bupivacaine 0.5% With Adjuncts

Serious: 0/45 (0%)

Deaths: 0/45

Other adverse events (7 terms — click to expand)

Reaction	System	Liposomal Bupivacaine 1.3%	Bupivacaine 0.5% With Adju…
Nausea and vomiting	General disorders	—	—
Bruising	Surgical and medical procedures	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Swelling	Surgical and medical procedures	—	—
Inflammation	Surgical and medical procedures	—	—
Ringing in ears	Ear and labyrinth disorders	—	—
Numbness and tingling	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT03887650 adverse events section.

Sponsor's own description

This will be a single-center, prospective, randomized controlled cross-sectional study comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine with epinephrine and PF dexamethasone in patients undergoing primary shoulder arthroplasty. Primary endpoint will be total opioid consumption in the first three post-operative days.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03887650 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hartford Hospital
Last refreshed: 15 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03887650.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing