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Completed

NCT Number: NCT06725485

Low-Dose Lidocaine Infusion for Acute Pain Management 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-Dose Lidocaine

Drug

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

Primary outcomes

  1. 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

  1. Pain Scale at 72 Hours Post-Surgery

    Time frame: Post-operative day 3

    Patient numeric pain scale rating (0-10), with 0 being no pain and 10 being the worst pain possible

  2. Opioid-Free Days

    Time frame: 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

  3. Time Until Return in bowel function

    Time frame: Time of surgery through discharge, up to 30 days

    Post-operative day when patient first has a bowel movement

  4. Return to Oral Feeding

    Time frame: Time of surgery through discharge, up to 30 days

    Post-operative day number when patient returns to oral feeding

  5. Post-operative intensive care unit length of stay

    Time frame: 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

  6. Post-operative hospital length of stay

    Time frame: Time of surgery through hospital discharge, up to 1 year

    Number of days between surgery and discharge from hospital after surgery

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Low-Dose Lidocaine Infusion for Acute Pain Management in the Surgical Intensive Care Unit - A Pilot Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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