Total Shoulder ArthroplastyPhase 4NCT05900427
Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients
A Phase 4 study testing Liposomal bupivacaine and Bupivacaine in people with Total Shoulder Arthroplasty and Reverse Total Shoulder Arthroplasty, run by Johnny K. Lee at 1 site in United States.
Trial summary
The purpose of this trial is to compare the difference in the proportion of patients with tolerable pain scores, VAS pain scores, quality of recovery and opioid use in milligram equivalents (at 24, 48, 72, 96 and 120 hours postoperatively) in patients undergoing shoulder arthroplasty who receive interscalene blocks… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty
- What is being tested?
- Liposomal bupivacaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject ages 18-90 years old
- Male or Female subjects
- Weight ≥ 60 kg.
- Must be able to consent in English
Who cannot join
- Ages: <18 and >90
- Weight < 60 kg
- Multiple surgeries during one hospital stay
- Emergency surgery
- Allergy or any contraindication to local anesthetics used in trial.
- Pregnancy
Show all 11Show fewer
- Contraindicated for use of liposomal bupivacaine
- Severe liver/kidney disease
- Defined as a diagnosis of end-stage renal disease (ESRD) defined as being on dialysis
- Subject who received another local anesthetic block prior to the interscalene block.
- Unable to consent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Skokie, Illinois, 60076
About this study
Official title: A Double-Blind Randomized Comparison Trial of Postoperative Pain in Patients Undergoing Total Shoulder Arthroplasty Who Receive Interscalene Blocks With or Without Liposomal Bupivacaine (PoPTSAWoW Trial)
The purpose of this trial is to compare the difference in the proportion of patients with tolerable pain scores, VAS pain scores, quality of recovery and opioid use in milligram equivalents (at 24, 48, 72, 96 and 120 hours postoperatively) in patients undergoing shoulder arthroplasty who receive interscalene blocks with or without Liposomal Bupivacaine.
This is a prospective randomized, double-blinded, controlled trial that will enroll 130 subjects undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty. Participants who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either 36 mL of 0.5% bupivacaine (PB group) or 10 mL of liposomal bupivacaine and 20 mL of 0.25 % bupivacaine and 6 mL of saline (LB group).
Read the detailed description
Patients undergoing shoulder surgery can suffer from significant postoperative pain which can lead to an increase in recovery time, opioid use and potential dependency, and a decrease in quality of recovery. The interscalene brachial plexus block is a common effective regional anesthesia technique used for a variety of procedures involving the shoulder. The number of total shoulder arthroplasty surgeries being performed annually in the United States are increasing every year. Liposomal bupivacaine was FDA approved for use in patients undergoing interscalene block in 2018 to reduce postoperative pain from shoulder surgery. The information from the manufacturer indicates that the liposomal encapsulation may release the drug for up to approximately 72 hours after it has been administered, providing a prolonged analgesic effect. Evidence to the prolonged analgesic effect of liposomal bupivacaine has varied in the current literature. A recent meta-analysis suggested that liposomal bupivacaine may provide a statistically significant, but clinically insignificant decrease in opioid consumption and pain scores over time. The authors noted a possible limitation of their study is that the meta-analysis included a variety of surgical procedures and block techniques, and was not specific to shoulder surgery or interscalene block. The authors noted that this variability in anesthetic regimens between study groups could have affected the observed outcomes.
Recently, the investigators performed a retrospective quality improvement study to investigate the potential benefit of liposomal bupivacaine used for interscalene blocks among 491 patients undergoing shoulder arthroplasty between 2018 and 2021. The investigators compared the difference in the proportion of patients with clinically tolerable pain scores (defined as VAS ≤ 4) in those patients receiving liposomal bupivacaine vs. those receiving another local anesthetic (plain bupivacaine, mepivacaine or ropivacaine) vs. those receiving no block. The results of this study suggested there was significant difference in the proportion of patients with clinically tolerable pain scores when receiving liposomal bupivacaine during all observations and at 3 days postoperatively versus those patient that did not. The patients who received liposomal bupivacaine also had a significant reduction in morphine milligram equivalents (MMEs).
Based on the investigators retrospective results, the investigators performed a power analysis which allowed for the development of this prospective randomized double blinded trial comparing liposomal bupivacaine plus plain bupivacaine vs. plain bupivacaine only in near equipotent doses. The investigators believe that this is a very important and unique trial to perform as it could change the way pain management is delivered in this patient population. Longer acting local anesthetic used for interscalene blocks may increase the number of patients who have tolerable pain and require less or no opioids. This could reduce or inevitably eliminate the unwanted effects of opioids (nausea, vomiting, constipation, urinary retention, opioid induced respiratory depression, dependency and addiction) and result in an improvement in the quality of recovery of patients undergoing total shoulder arthroplasties.
- Being tested
- Liposomal bupivacaine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
Subjects randomized to the Liposomal bupivacaine group will receive 10 mL (133 mg) of Liposomal bupivacaine and 20 mL (50 mg) of 0.25% bupivacaine and 6 mL of saline (183 mg).
BupivacaineDrug
Also called Marcaine
Subjects randomized to the Plain Bupivacaine group will receive 36 mL (180 mg) of 0.5% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine Group | Experimental | 10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg) Receives: Drug: Liposomal bupivacaine |
| Plain Bupivacaine Group | Other | 36 mL (180 mg) 0.5% bupivacaine Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
The investigators will collect the difference in the proportion of patients with clinically significant tolerable pain scores (defined as Visual Analogue Scale (VAS) ≤ 4) Postoperative Day 1 in those patients receiving an interscalene block with liposomal bupivacaine with plain bupivacaine vs. plain bupivacaine. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
Measured: on Postoperative Day 1
Secondary outcomes (6)
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
The investigators will collect the difference in the proportion of patients with clinically significant tolerable pain scores (defined as Visual Analogue Scale (VAS) ≤ 4) at PACU admission, PACU discharge, and on postoperative days 2, 3, 4, and 5 in those patients receiving an interscalene block with liposomal bupivacaine with plain bupivacaine vs. plain bupivacaine. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
Measured: on PACU admission, PACU discharge, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, and Postoperative Day 5
The Difference in Visual Analogue Scale (VAS) Pain Scores (0 - 10)
The investigators will collect the difference in VAS pain scores (0 - 10) in each group. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
Measured: Upon Post Anesthesia Care Unit (PACU) Admission; PACU Discharge, Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, and Postoperative Day 5.
The Difference in Quality of Recovery Survey-15 Responses
The investigators will collect the difference in quality of recovery survey-15 responses in each group. QoR15 survey has 15 questions each with a scale of 0-10. Number "0" indicates none of the time and number "10" indicates all of the time. Total scores are reported as a sum with the maximum score being 150. 136 - 150: Excellent recovery 122 - 135: Good recovery 90 - 121: Moderate recovery 0 - 89: Poor recovery respectively
Measured: At baseline (before surgery) and on Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, and Postoperative Day 5.
Opioid Use in Morphine Milligram Equivalents (MME)
The investigators will collect opioid use in morphine milligram equivalents (MME) data from the patients electronic medical record and via an electronic survey sent to patients on postoperative days 1-5.
Measured: On the day of surgery in the PACU, Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, Postoperative and Day 5.
Consumption of Non-opioid Analgesics
The investigators will collect the use of non-opioid analgesics (ibuprofen and acetaminophen) data from the patients electronic medical record and via an electronic survey sent to patients.
Measured: On the day of surgery (PACU), Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, and Postoperative Day 5
Adverse Block Event Survey
The investigators will monitor patients for any adverse reaction to the interscalene block by distributing an electronic survey asking if the following symptoms/scenarios occured: persistent numbness/tingling/weakness, tinnitus, metallic taste, irregular heartbeat, seizures, ER or hospital admission. On day 30, only the questions about persistent numbness/tingling/weakness and ER or hospital admission were asked.
Measured: On Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, Postoperative Day 5, and Postoperative Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start23 Oct 2023
- Primary completion5 Oct 2025
- Study completion1 Dec 2025
Why it stopped: Due to resource limitations and the lack of difference observed between study groups after the interim analysis, the study was halted prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Total Shoulder ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnny K. Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Endeavor Health
- Responsible party
- Sponsor-investigator, Johnny K. Lee, Endeavor Health
- Investigators
- Johnny K Lee, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900427
- Sponsor's protocol ID
- EH23-069
- Status last verified
- Jun 2026
- First submitted
- 22 May 2023
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Publications
Lee HY, Kim SH, So KY, Kim DJ. Effects of interscalene brachial plexus block to intra-operative hemodynamics and postoperative pain for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Jan;62(1):30-4. doi: 10.4097/kjae.2012.62.1.30. Epub 2012 Jan 25.
PubMed 22323951Mirza F, Brown AR. Ultrasound-guided regional anesthesia for procedures of the upper extremity. Anesthesiol Res Pract. 2011;2011:579824. doi: 10.1155/2011/579824. Epub 2011 May 30.
PubMed 21716734Best MJ, Aziz KT, Wilckens JH, McFarland EG, Srikumaran U. Increasing incidence of primary reverse and anatomic total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2021 May;30(5):1159-1166. doi: 10.1016/j.jse.2020.08.010. Epub 2020 Aug 26.
PubMed 32858194Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.
PubMed 22067185Hussain N, Brull R, Sheehy B, Essandoh MK, Stahl DL, Weaver TE, Abdallah FW. Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve Block Analgesia. Anesthesiology. 2021 Feb 1;134(2):147-164. doi: 10.1097/ALN.0000000000003651.
PubMed 33372953Elmer DA, Coleman JR, Renwick CM, Amato PE, Werner BC, Brockmeier SF, Slee AE, Hanson NA. Comparing bupivacaine alone to liposomal bupivacaine plus bupivacaine in interscalene blocks for total shoulder arthroplasty: a randomized, non-inferiority trial. Reg Anesth Pain Med. 2023 Jan;48(1):1-6. doi: 10.1136/rapm-2022-103997. Epub 2022 Oct 19.
PubMed 36261261Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
PubMed 23411725
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomized Comparison Trial of Postoperative Pain in Patients Undergoing Total Shoulder Arthroplasty Who Receive Interscalene Blocks With or Without Liposomal Bupivacaine (PoPTSAWoW Trial)
- ClinicalTrials.gov ID
- NCT05900427
- Acronym / sponsor ID
- EH23-069
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to resource limitations and the lack of difference observed between study groups after the interim analysis, the study was halted prematurely.
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Johnny K. LeeUniversity, hospital or other
- Collaborators
- Endeavor Health
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 5 Oct 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to compare the difference in the proportion of patients with tolerable pain scores, VAS pain scores, quality of recovery and opioid use in milligram equivalents (at 24, 48, 72, 96 and 120 hours postoperatively) in patients undergoing shoulder arthroplasty who receive interscalene blocks with or without Liposomal Bupivacaine.
This is a prospective randomized, double-blinded, controlled trial that will enroll 130 subjects undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty. Participants who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either 36 mL of 0.5% bupivacaine (PB group) or 10 mL of liposomal bupivacaine and 20 mL of 0.25 % bupivacaine and 6 mL of saline (LB group).
Detailed description
Patients undergoing shoulder surgery can suffer from significant postoperative pain which can lead to an increase in recovery time, opioid use and potential dependency, and a decrease in quality of recovery. The interscalene brachial plexus block is a common effective regional anesthesia technique used for a variety of procedures involving the shoulder. The number of total shoulder arthroplasty surgeries being performed annually in the United States are increasing every year. Liposomal bupivacaine was FDA approved for use in patients undergoing interscalene block in 2018 to reduce postoperative pain from shoulder surgery. The information from the manufacturer indicates that the liposomal encapsulation may release the drug for up to approximately 72 hours after it has been administered, providing a prolonged analgesic effect. Evidence to the prolonged analgesic effect of liposomal bupivacaine has varied in the current literature. A recent meta-analysis suggested that liposomal bupivacaine may provide a statistically significant, but clinically insignificant decrease in opioid consumption and pain scores over time. The authors noted a possible limitation of their study is that the meta-analysis included a variety of surgical procedures and block techniques, and was not specific to shoulder surgery or interscalene block. The authors noted that this variability in anesthetic regimens between study groups could have affected the observed outcomes.
Recently, the investigators performed a retrospective quality improvement study to investigate the potential benefit of liposomal bupivacaine used for interscalene blocks among 491 patients undergoing shoulder arthroplasty between 2018 and 2021. The investigators compared the difference in the proportion of patients with clinically tolerable pain scores (defined as VAS ≤ 4) in those patients receiving liposomal bupivacaine vs. those receiving another local anesthetic (plain bupivacaine, mepivacaine or ropivacaine) vs. those receiving no block. The results of this study suggested there was significant difference in the proportion of patients with clinically tolerable pain scores when receiving liposomal bupivacaine during all observations and at 3 days postoperatively versus those patient that did not. The patients who received liposomal bupivacaine also had a significant reduction in morphine milligram equivalents (MMEs).
Based on the investigators retrospective results, the investigators performed a power analysis which allowed for the development of this prospective randomized double blinded trial comparing liposomal bupivacaine plus plain bupivacaine vs. plain bupivacaine only in near equipotent doses. The investigators believe that this is a very important and unique trial to perform as it could change the way pain management is delivered in this patient population. Longer acting local anesthetic used for interscalene blocks may increase the number of patients who have tolerable pain and require less or no opioids. This could reduce or inevitably eliminate the unwanted effects of opioids (nausea, vomiting, constipation, urinary retention, opioid induced respiratory depression, dependency and addiction) and result in an improvement in the quality of recovery of patients undergoing total shoulder arthroplasties.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine Group | Experimental | Drug: Liposomal bupivacaine10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg) |
| Plain Bupivacaine Group | Other | Drug: Bupivacaine36 mL (180 mg) 0.5% bupivacaine |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject ages 18-90 years old
- Male or Female subjects
- Weight ≥ 60 kg.
- Must be able to consent in English
Key exclusion criteria (11 listed)
- Ages: <18 and >90
- Weight < 60 kg
- Multiple surgeries during one hospital stay
- Emergency surgery
- Allergy or any contraindication to local anesthetics used in trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaineAlso: ExparelSubjects randomized to the Liposomal bupivacaine group will receive 10 mL (133 mg) of Liposomal bupivacaine and 20 mL (50 mg) of 0.25% bupivacaine and 6 mL of saline (183 mg). | Drug | Liposomal Bupivacaine Group |
| BupivacaineAlso: MarcaineSubjects randomized to the Plain Bupivacaine group will receive 36 mL (180 mg) of 0.5% bupivacaine. | Drug | Plain Bupivacaine Group |
Primary outcome
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
Time frame: on Postoperative Day 1
The investigators will collect the difference in the proportion of patients with clinically significant tolerable pain scores (defined as Visual Analogue Scale (VAS) ≤ 4) Postoperative Day 1 in those patients receiving an interscalene block with liposomal bupivacaine with plain bupivacaine vs. plain bupivacaine. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
6 secondary outcomes
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores
Time frame: on PACU admission, PACU discharge, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, and Postoperative Day 5
The Difference in Visual Analogue Scale (VAS) Pain Scores (0 - 10)
Time frame: Upon Post Anesthesia Care Unit (PACU) Admission; PACU Discharge, Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, and Postoperative Day 5.
The Difference in Quality of Recovery Survey-15 Responses
Time frame: At baseline (before surgery) and on Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, and Postoperative Day 5.
Opioid Use in Morphine Milligram Equivalents (MME)
Time frame: On the day of surgery in the PACU, Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, Postoperative and Day 5.
Consumption of Non-opioid Analgesics
Time frame: On the day of surgery (PACU), Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, and Postoperative Day 5
Adverse Block Event Survey
Time frame: On Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 4, Postoperative Day 5, and Postoperative Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22323951Lee HY, Kim SH, So KY, Kim DJ. Effects of interscalene brachial plexus block to intra-operative hemodynamics and postoperative pain for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Jan;62(1):30-4. doi: 10.4097/kjae.2012.62.1.30. Epub 2012 Jan 25.
- Results publication: PubMed 21716734Mirza F, Brown AR. Ultrasound-guided regional anesthesia for procedures of the upper extremity. Anesthesiol Res Pract. 2011;2011:579824. doi: 10.1155/2011/579824. Epub 2011 May 30.
- Results publication: PubMed 32858194Best MJ, Aziz KT, Wilckens JH, McFarland EG, Srikumaran U. Increasing incidence of primary reverse and anatomic total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2021 May;30(5):1159-1166. doi: 10.1016/j.jse.2020.08.010. Epub 2020 Aug 26.
- Results publication: PubMed 22067185Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.
- Results publication: PubMed 33372953Hussain N, Brull R, Sheehy B, Essandoh MK, Stahl DL, Weaver TE, Abdallah FW. Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve Block Analgesia. Anesthesiology. 2021 Feb 1;134(2):147-164. doi: 10.1097/ALN.0000000000003651.
- Results publication: PubMed 36261261Elmer DA, Coleman JR, Renwick CM, Amato PE, Werner BC, Brockmeier SF, Slee AE, Hanson NA. Comparing bupivacaine alone to liposomal bupivacaine plus bupivacaine in interscalene blocks for total shoulder arthroplasty: a randomized, non-inferiority trial. Reg Anesth Pain Med. 2023 Jan;48(1):1-6. doi: 10.1136/rapm-2022-103997. Epub 2022 Oct 19.
- Results publication: PubMed 23411725Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnny K Lee, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine and Bupivacaine in people with Total Shoulder Arthroplasty and Reverse Total Shoulder Arthroplasty, run by Johnny K. Lee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Difference in the Proportion of Patients With Clinically Significant Tolerable Pain Scores (time frame: on Postoperative Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05900427, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.