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

NCT07535411 | Not Yet Recruiting Phase 4

• 1 other identifier: 2026P000774
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Analgesia Assessment

Keywords

Liposomal Bupivicaine; Exparel; Local Anesthesia

Outcome Measures

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.

  pre-procedure, intra-procedure, Immediately post-procedure and 24 hours following the procedure

Secondary Outcomes (1)

• Post-Procedural Analgesic Requirements and Opioid Use

  Cumulative Post-Procedural Analgesic Requirements and Opioid Use (0-24 Hours)

Study Arms (1)

Liposomal Bupivacaine Arm

EXPERIMENTAL

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

Interventions

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.

Liposomal Bupivacaine Arm

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• chronic pain condition

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Non OR Anesthesiology

Model Details: Single-arm interventional study evaluating peri-procedural pain and analgesic outcomes in 10 patients receiving liposomal bupivacaine during interventional radiology procedures.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04