Post Procedural Pain Following Intercostal Nerve Block For Right-Sided Percutaneous Transhepatic Biliary Catheter Placement

M
Matthew Krosin, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
150 participants needed
2 Locations

Brief description of study

What is the purpose of this study?
Percutaneous intercostal biliary drain placement for benign biliary strictures is a relatively common procedure in interventional radiology that often results in increased morbidity in the acute and subacute postprocedural period, with pain often being the most common adverse outcome experienced by patients. Our purpose with this study is to prospectively compare pain relief in the acute and subacute periprocedural period, as measured by visual analog scale, between preprocedural intercostal nerve block with bupivicaine + methylprednisolone vs standard of care (general anesthesia and local/subcutaneous lidocaine injection) in patients with benign biliary strictures whom present for first-time biliary catheter placement. The intervention arm will receive both standard of care plus the intervention nerve block with bupivacaine and methylprednisolone.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Research will take place at IU Health hospitals (University and Methodist Hospitals) in Indianapolis, Indiana. Patients will be identified t he day-of, or day-prior, to their catheter placement given the usual nature of this disease process at presentation. Eligible subjects who present for initial right-sided percutaneous biliary catheter placement will be evaluated for inclusion in this study. 

Detailed description of study

What will happen during the study?

Single-blind, randomized control trial comparing the addition of an intercostal methylprednisolone and bupivacaine nerve block + standard of care vs. sham nerve block + standard of care for postprocedural pain following initial right-sided PTBD placement. The primary outcome measure will be post-procedural pain, as assessed by VAS. VAS will be administered with predetermined verbiage each time to reduce potential bias. Following initial catheter placement, all VAS will be administered by a blinded proceduralist during catheter exchange/upsize. This intervention will not affect management of the participant’s biliary stricture.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Central and peripheral benign biliary strictures
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria 
    Adults ≥ 18 years
    Patients with central and peripheral benign biliary strictures presenting for first time right-sided intercostal biliary catheter placement
Exclusion Criteria 
    Patients with malignant biliary strictures
    Patients requiring subcostal drain placement
    Patients with allergies to Bupivacaine and/or Methylprednisolone
    Patients unable to reliably return for clinic appointments or telehealth visits
    Patients with chronic, uncontrolled pain
    Patients with preexisting neuropathy
    Patients with diabetes and ocular complications
    Patients with prior major thoracic surgery
    Patients who are pregnant or are planning to become pregnant
    Patients who cannot consent for themselves.

Updated on 19 Feb 2025. Study ID: RADY-IIR-22821, 22821
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