Efficacy of Liposomal Bupivacaine for Pain Control After Percutaneous Nephrostolithotomy

• Status: Withdrawn
• Trial end date: 2017-08-08
• Target enrollment: 0
• Participant gender: All

Summary

Percutaneous nephrostolithotomy (PCNL) is a common endoscopic procedure performed for upper urinary tract calculus disease. Despite being minimally invasive, it is associated with significant postoperative pain, often necessitating inpatient hospitalization and narcotic pain medications. Additionally, one of a number of catheters is often left protruding from the access tract for a period of time following the procedure, adding to patient discomfort. Attempts have been made to study peri-tubular or access tract analgesic installation, which have shown promise.1-2 However, no studies, to our knowledge, have examined the use of liposomal bupivacaine preparations in this regard. In this study we hope to prospectively analyze the use of liposomal bupivacaine injected to the access tract site at the time of PCNL and determine its effects on postoperative narcotic requirement and pain scores.

Patients presenting for PCNL will be randomized to either the liposomal bupivacaine or usual care, which involves no injection of local anesthesia. Patients will then be followed during their inpatient stay. Total narcotic requirement (in milligrams) and pain scores (using Wong-Baker FACES rating scale) will be compared.3 Typical postoperative care and discharge criteria will not change during the course of this study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Northwell Health
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

1. Patients >18 years old

2. Patients with calculus disease that can be treated with PCNL

Exclusion Criteria:

1. Patients <18 years old.

2. Patients who are not able to give consent for study

3. Patients with active urinary tract infection

4. Pregnant women

5. Patients with hepatic insufficiency

6. Patients with more than 2 access tracts created

7. Allergies to bupivacaine or liposomal bupivacaine

8. Patients with chronic pain syndromes as determined by using >30mg oral morphine equivalents per day

9. Patients who are neurologically impaired and may have altered pain sensation due to previous diseases (e.g. paraplegics, quadriplegics, systemic neurological condition, etc.)

10. Patients who are undergoing staged procedures during that same hospital stay

11. Patients who are placed on patient controlled analgesia or patient controlled epidural analgesia

12. Patients who remain intubated after surgery

13. Patients who will have ureteral stents

14. Patients who do not require care in the intensive care unit

15. Patients who are mentally impaired.

16. Patients who are criminal prisoners.