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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain Management
• Intervention / Treatment: Drug: Low-Dose Lidocaine

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Dose Lidocaine Infusion; Low-dose lidocaine infusion 10-30 mcg/kg/min administered within 1 hour of ICU admission.	Drug: Low-Dose Lidocaine; Low-dose lidocaine infusion 10-30 mcg/kg/min administered within 1 hour of ICU admission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption on post-operative day 3	Opioid consumption in a 24-hour period starting 3 days after surgery, measured in morphine milligram equivalents	Post-operative day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scale at 72 Hours Post-Surgery	Patient numeric pain scale rating (0-10), with 0 being no pain and 10 being the worst pain possible	Post-operative day 3
Opioid-Free Days	The proportion of days post-surgery that the patient did not require opioid analgesia	Time of surgery through the end of post-operative day 3
Time Until Return in bowel function	Post-operative day when patient first has a bowel movement	Time of surgery through discharge, up to 30 days
Return to Oral Feeding	Post-operative day number when patient returns to oral feeding	Time of surgery through discharge, up to 30 days
Post-operative intensive care unit length of stay	Number of days between surgery and discharge from the intensive care unit after surgery	Time of surgery through intensive care unit discharge, up to 1 year
Post-operative hospital length of stay	Number of days between surgery and discharge from hospital after surgery	Time of surgery through hospital discharge, up to 1 year

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Actual): February 16, 2024
• Study Completion (Actual): June 17, 2024

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: PRO00027972

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes