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Low-Dose Lidocaine Infusion for Acute Pain Management Pilot Study

NCT ID: NCT06725485

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-02

Study Completion Date

2024-06-17

Brief Summary

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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

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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.

Conditions

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Postoperative Pain Management

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low-Dose Lidocaine Infusion

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

Group Type EXPERIMENTAL

Low-Dose Lidocaine

Intervention Type DRUG

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

Interventions

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Low-Dose Lidocaine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Methodist Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Hina Faisal

Assistant Professor of Clinical Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Houston Methodist Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PRO00027972

Identifier Type: -

Identifier Source: org_study_id