Bupivacaine Liposome Suspension Administration to Decreasre Peri-procedural Pain in Interventional Radiology (IR) Procedures

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-95
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

chronic pain condition

Trial design

Design model

Single group

Treatments tested in this trial

  • Liposomal Bupivacaine (EXPAREL®)/Bupivacaine

    Drug

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Liposomal Bupivacaine ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: