Low-Dose Lidocaine Infusion for Acute Pain Management in the Surgical Intensive Care Unit - A Pilot Study
Overview
- Phase
- Phase 4
- Intervention
- Low-Dose Lidocaine
- Conditions
- Postoperative Pain Management
- Sponsor
- The Methodist Hospital Research Institute
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Opioid consumption on post-operative day 3
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Hina Faisal
Assistant Professor of Clinical Surgery
The Methodist Hospital Research Institute
Eligibility Criteria
Inclusion Criteria
- •Males or females age \> 18 years admitted to surgical ICU.
- •Severe acute pain with pain scale \> 7, following open exploratory laparotomy for bowel, gall bladder, and pancreatic surgeries.
- •Women of childbearing age must have a negative urine/serum pregnancy test.
Exclusion Criteria
- •Regional anesthesia during surgery
- •Heart failure with ejection fraction \< 20%.
- •Allergy to amide local anesthetics
- •Neuraxial anesthesia during surgery
- •Post-liver transplant patients
- •Hemodynamically unstable patients on two or more vasopressors
- •Child-Pugh Class C or MELD \>20
- •Any investigational drug use within 30 days before enrollment
- •Pregnant or lactating females
- •Patients with chronic opioid-dependence
Arms & Interventions
Low-Dose Lidocaine Infusion
Low-dose lidocaine infusion 10-30 mcg/kg/min administered within 1 hour of ICU admission.
Intervention: Low-Dose Lidocaine
Outcomes
Primary Outcomes
Opioid consumption on post-operative day 3
Time Frame: Post-operative day 3
Opioid consumption in a 24-hour period starting 3 days after surgery, measured in morphine milligram equivalents
Secondary Outcomes
- Pain Scale at 72 Hours Post-Surgery(Post-operative day 3)
- Opioid-Free Days(Time of surgery through the end of post-operative day 3)
- Time Until Return in bowel function(Time of surgery through discharge, up to 30 days)
- Return to Oral Feeding(Time of surgery through discharge, up to 30 days)
- Post-operative intensive care unit length of stay(Time of surgery through intensive care unit discharge, up to 1 year)
- Post-operative hospital length of stay(Time of surgery through hospital discharge, up to 1 year)