NCT06725485

Low-Dose Lidocaine Infusion for Acute Pain Management Pilot Study

Low-Dose Lidocaine Infusion for Acute Pain Management in the Surgical Intensive Care Unit - A Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of lidocaine infusion in acute pain management following open abdominal surgery, including opiate use after surgery and the incidence of postoperative nausea and vomiting, Ileus, length of stays (ICU/hospital), and improvement in patient satisfaction.

Detailed description

The management of acute pain remains challenging for the physicians, with many patients suffering from inadequate pain control following surgery. Evidence has shown that 90% of patients in the intensive care unit usually treated with opioids for pain. Poorly controlled pain and opioid-related adverse events have several negative consequences for critically ill patients during the postoperative period, including delay in functional recovery and hospital discharge, increased length of stay, development of chronic postsurgical pain, reduced patient satisfaction, and increased total healthcare cost. The reported incidence of postoperative Ileus varies with the procedure, ranging from 14.9% for large-bowel resection and 19.2% for small-bowel resection). Although many analgesic therapies are available, the high incidence of postoperative pain among patients indicates that there are still significant treatment challenges. Recently, there has been much interest in using low-dose lidocaine infusion for acute pain management in the operating room or/and PACU. Lidocaine is a drug with multiple effects, including anti-arrhythmic, local, topical, and injectable anesthetics. Lidocaine is also used for uncontrolled and chronic pain. However, this is an off-label use. Additionally, I.V. lidocaine is a potent anti-inflammatory, anti-hyperalgesic, and gastrointestinal pro-peristaltic drug. There is a lack of data on low dose lidocaine infusion for acute postoperative pain management in surgical critical care patients.

Conditions

• Postoperative Pain Management

Interventions

Type	Name	Description
DRUG	Low-Dose Lidocaine	Low-dose lidocaine infusion 10-30 mcg/kg/min administered within 1 hour of ICU admission.

Timeline

• Start date: 2021-07-02
• Primary completion: 2024-02-16
• Completion: 2024-06-17
• First posted: 2024-12-10
• Last updated: 2024-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study