Low-Dose Lidocaine Infusion for Acute Pain Management Pilot Study

Phase 4

Completed

• Conditions: Postoperative Pain Management
• Interventions: Drug: Low-Dose Lidocaine

• Registration Number: NCT06725485
• Lead Sponsor: The Methodist Hospital Research Institute

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.

Study Timeline

• Study Start: 2021-07-02
• Primary Completion: 2024-02-16
• Study Completion: 2024-06-17
• Study First Submitted: 2024-11-19
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low-Dose Lidocaine Infusion	Low-Dose Lidocaine	Low-dose lidocaine infusion 10-30 mcg/kg/min administered within 1 hour of ICU admission.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States