A Phase 4 interventional study of Liposomal Bupivacaine (EXPAREL®)/Bupivacaine in Analgesia Assessment, sponsored by Massachusetts General Hospital. Not yet recruiting. Open to participants aged 18 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment
This study evaluates the use of liposomal bupivacaine (Exparel), a long-acting local anesthetic, for peri-procedural pain control in patients undergoing interventional radiology (IR) procedures. Effective pain management during and after IR procedures is important for patient comfort, procedural success, and recovery, yet standard local anesthetics (e.g., lidocaine or bupivacaine HCl) provide relatively short durations of analgesia.
Liposomal bupivacaine is an FDA-approved formulation designed to provide extended-release local anesthetic effects over a prolonged period. Its use has been studied in surgical settings, but data in interventional radiology procedures remain limited. This prospective, single-arm quality improvement initiative aims to assess whether incorporation of liposomal bupivacaine into routine procedural care improves patient-reported pain outcomes.
Adult patients undergoing IR procedures will receive liposomal bupivacaine administered by the proceduralist as part of standard care. Pain will be assessed using a structured patient-reported outcome survey at multiple time points, including pre-procedure, during the procedure, 1 hour post-procedure, and within 24 hours post-procedure. The survey also captures use of additional analgesic medications within the first 24 hours.
The primary outcome is patient-reported pain intensity. Secondary outcomes include post-procedural analgesic utilization. Data will be analyzed descriptively given the exploratory nature and small sample size.
Findings from this project may inform future approaches to pain management in interventional radiology and help determine whether longer-acting local anesthetics provide clinically meaningful improvements in patient experience.
Background and Rationale
Effective peri-procedural pain control is an important component of interventional radiology (IR) procedures, influencing patient comfort, procedural tolerance, and recovery. Standard local anesthetics such as lidocaine and bupivacaine hydrochloride provide relatively short durations of analgesia, which may not extend sufficiently into the post-procedural period.
Liposomal bupivacaine (Exparel) is an extended-release formulation of bupivacaine designed to provide prolonged local anesthetic effect following a single administration. While this formulation has been studied in surgical settings, its role in minimally invasive interventional radiology procedures is less well defined.
This quality improvement initiative is designed to evaluate whether the use of liposomal bupivacaine during IR procedures improves patient-reported pain outcomes and reduces the need for additional analgesics in the immediate post-procedural period.
Study Design
This is a prospective, single-arm, open-label quality improvement study conducted in adult patients undergoing interventional radiology procedures. All participants will receive liposomal bupivacaine as part of procedural care.
The study is exploratory in nature and is intended to generate preliminary data on patient-reported pain outcomes associated with the intervention.
Study Population
Inclusion Criteria:
Adults (≥18 years of age) Undergoing an interventional radiology procedure Able to provide informed consent
Exclusion Criteria:
Known allergy to bupivacaine or other amide local anesthetics History of chronic pain conditions Patients under 18 years of age Patients who do not consent to participation
Patients will be identified through routine clinical scheduling and approached on the day of the procedure by study personnel.
Intervention
Participants will receive liposomal bupivacaine administered by the interventional radiology provider at the procedural site.
The study preparation consists of:
10 mL of 0.5% bupivacaine hydrochloride 10 mL of liposomal bupivacaine (Exparel 1.3%, 133 mg/10 mL)
These are combined and administered via local infiltration at the procedural site in accordance with standard clinical practice.
Liposomal bupivacaine is FDA-approved for local infiltration; its use in this context may be considered off-label depending on the specific procedural indication.
Study Procedures and Data Collection Pain Assessment
Pain will be assessed using a structured patient-reported outcome survey developed for this project. The survey is informed by established pain assessment tools and captures pain intensity using a 0-10 numeric rating scale.
Pain scores will be collected at the following time points:
Immediately prior to the procedure During the procedure (maximum pain experienced)
1 hour post-procedure Within 24 hours post-procedure (maximum pain experienced) Analgesic Use
Participants will report whether additional analgesics were required within 24 hours after the procedure. Responses will be categorized as:
No additional analgesics Non-opioid analgesics Opioid analgesics Not sure Follow-Up
Follow-up data collection will occur either:
In person (for hospitalized patients), or Via telephone within 24 hours post-procedure Outcome Measures
Primary Outcome:
Patient-reported pain intensity (0-10 numeric rating scale) across defined peri-procedural time points
Secondary Outcomes:
Use of additional analgesics within 24 hours post-procedure Type of analgesics used (opioid vs non-opioid) Sample Size and Statistical Analysis
Approximately 10 participants will be enrolled. Given the small sample size, analyses will be descriptive and exploratory.
Pain scores will be summarized using measures of central tendency (e.g., mean, median) and variability. Analgesic use will be reported as proportions. No formal hypothesis testing is planned.
Risks and Safety
Risks associated with liposomal bupivacaine are similar to those of standard local anesthetics and include:
Injection site pain, bleeding, or infection Local tissue irritation or inflammation Allergic reactions Rare risk of local anesthetic systemic toxicity
Participation in the survey presents minimal risk and primarily involves minor inconvenience.
Patients will be monitored during procedures using standard clinical monitoring, including heart rate, blood pressure, oxygen saturation, and other routine parameters as indicated.
Benefits
Participants may experience improved peri-procedural pain control. There is no guarantee of direct benefit. The information obtained from this study may help improve pain management strategies for future patients undergoing interventional radiology procedures.
Data Management and Confidentiality
All data will be de-identified and stored in secure, password-protected systems accessible only to authorized study personnel. Data handling will comply with institutional privacy policies and applicable regulations, including HIPAA.
Monitoring
The Principal Investigator will oversee study conduct, data integrity, and safety monitoring. Given the minimal risk and quality improvement nature of the study, no Data Safety Monitoring Board is planned.
Significance
This study aims to generate preliminary data on the feasibility and effectiveness of liposomal bupivacaine for pain control in interventional radiology procedures. Findings may inform future studies and guide improvements in peri-procedural pain management.
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
-
Exclusion Criteria:
Participants undergoing interventional radiology procedures will receive liposomal bupivacaine administered via local infiltration at the procedural site as part of peri-procedural pain management. The intervention will be performed using standard dosing and technique at the discretion of the treating physician. Pain scores and analgesic requirements will be collected following the procedure to assess outcomes.
Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
Liposomal bupivacaine will be administered via local infiltration at the procedural site to provide analgesia. This formulation consists of bupivacaine encapsulated in liposomes, allowing for slow release of the anesthetic over time and potentially prolonged pain control compared to standard bupivacaine. The medication will be used as part of routine peri-procedural pain management during interventional radiology procedures.
Pain Scores
Patient-reported pain scores will be assessed using a standardized numeric rating scale (e.g., 0-10) following interventional radiology procedures in which liposomal bupivacaine is administered. Pain scores will be collected to evaluate peri-procedural analgesic effectiveness.
Time frame: pre-procedure, intra-procedure, Immediately post-procedure and 24 hours following the procedure
Post-Procedural Analgesic Requirements and Opioid Use
The need for additional analgesic medications following the procedure will be assessed, including the use of non-opioid and opioid analgesics. Data will include whether additional analgesia was required, type of medication administered, and presence or absence of opioid use, to evaluate the effectiveness of liposomal bupivacaine in reducing post-procedural analgesic needs.
Time frame: Cumulative Post-Procedural Analgesic Requirements and Opioid Use (0-24 Hours)
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital