Clinical trial NCT06725485: Low-Dose Lidocaine Infusion for Acute Pain Management Pilot Study
Official title: Low-Dose Lidocaine Infusion for Acute Pain Management in the Surgical Intensive Care Unit - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain Management
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* Intubated and mechanically ventilated patients on intensive care unit analgo-sedation
* Subjects who do not agree to participate or may be non-compliant with study schedules or procedures.

Primary outcomes:
measure: Opioid consumption on post-operative day 3
timeFrame: Post-operative day 3
Secondary outcomes:
measure: Pain Scale at 72 Hours Post-Surgery
timeFrame: Post-operative day 3
measure: Opioid-Free Days
timeFrame: Time of surgery through the end of post-operative day 3
measure: Time Until Return in bowel function
timeFrame: Time of surgery through discharge, up to 30 days
measure: Return to Oral Feeding
timeFrame: Time of surgery through discharge, up to 30 days
measure: Post-operative intensive care unit length of stay
timeFrame: Time of surgery through intensive care unit discharge, up to 1 year
measure: Post-operative hospital length of stay
timeFrame: Time of surgery through hospital discharge, up to 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
References: