Low-Dose Lidocaine Infusion for Acute Pain Management Pilot Study

NCT06725485 | Completed Phase 4 FDA Drug

• 1 other identifier: PRO00027972
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Low-Dose Lidocaine Infusion

EXPERIMENTAL

Low-dose lidocaine infusion 10-30 mcg/kg/min administered within 1 hour of ICU admission.

Drug: Low-Dose Lidocaine

Interventions

Low-Dose Lidocaine DRUG

Low-dose lidocaine infusion 10-30 mcg/kg/min administered within 1 hour of ICU admission.

Low-Dose Lidocaine Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Surgery

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 10, 2024
• Study Start: July 2, 2021
• Primary Completion: February 16, 2024
• Study Completion: June 17, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)