Low-Dose Lidocaine Infusion for Acute Pain Management Pilot Study

The Methodist Hospital Research Institute (TMHRI)

Status and phase

Completed

Phase 4

Conditions

Postoperative Pain Management

Treatments

Drug: Low-Dose Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT06725485

PRO00027972

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.