Intra-operative Lidocaine Infusion in Preventing CPSP Post VATs

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate the impact of intravenous lidocaine on acute and chronic post surgical pain on patients undergoing video assisted thoracoscopic surgery(VATS). The investigators believe that systemic administration of lidocaine during the perioperative period would be effective in preventing chronic pain post VATS. In addition to chronic pain the investigators believe it will reduce acute postoperative pain as well as each patients total opioid requirement.The investigators believe that this will have a significant impact on the care of patients presenting for VATS.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intravenous Lidocaine Infusion During Video-assisted Thoracic Procedures for Improved Pain Control

NCT01277835

Pain

COMPLETED NA

Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

NCT03677817

Postoperative Pain

COMPLETED PHASE3

Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Morphine-rachi Analgesia

NCT07076641

Digestive System Disease Surgery

NOT_YET_RECRUITING PHASE3

Effect of Perioperative Intravenous Lidocaine on Postoperative Quality of Recovery in Patients Undergoing Spine Surgery

NCT01930877

Pain

WITHDRAWN PHASE2

Impact of Intra- and Postoperative Continuous Infusion of Lidocaine on Analgesia in Vascular Anaesthesia

NCT04691726

Abdominal Aorta Aneurysm Abdominal Aorta Atheroma Surgery +1 more

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

It is not surprising that complications related to surgical procedures occur. Chronic Post Surgical Pain (CPSP) is considered one of the more common surgical complications, despite all the advances in understanding acute pain and the development of new modalities for pain management 1. Chronic Post Surgical Pain was defined by Macrae and Davies 7 as a persistent pain, which existed for a minimum of two months following a surgical procedure. The condition of pre-existence of pain, and causes for the pain other than surgery should be excluded. Thoracic surgeries including thoracotomy and video-assisted thoracoscopic surgery (VATS) are some of the highest risk procedures that often lead to CPSP. The prevalence of chronic pain after VATS is close to that after thoracotomy (25-47 %), half of them having neuropathic pain A, B. Because of the fact that chronic pain is a major physical and mental health care problem affecting the patient and the community in general, it has become essential for physicians to prevent the development of chronic pain 8.

While multimodal analgesia has largely replaced pain mono-therapy with opioids, they remain the most commonly used medications to treat post operative pain. Lidocaine is an amide local anesthetic which when used intravenously demonstrates significant analgesic, anti-hyperalgesic and anti-inflammatory properties . It also reduces the sensitivity and activity of spinal cord neurons, decreases N-methyl-D-aspartate (NMDA) receptors mediated post-synaptic depolarization. The analgesic effects of systemic lidocaine were first tested in chronic neuropathic pain when the results support the usage of these drugs. Perioperatively, when lidocaine is administered as a continuous infusion at clinically relevant doses (1-2 mg/kg/hr) results in plasma concentration below 5µg.mL-1. At this plasma level, it is adequate to attenuate sympathetic responses , decrease pain and demonstrate a significant opioid sparing effect. Perioperative lidocaine administration was associated with a decreased incidence of CPSP when it is associated with neuropathic pain . It reduced CPSP in mastectomy by 40-50% after 3 and 6 months follow-up. To the best of our knowledge there is no study that has addressed the usage of lidocaine in VATS or thoracotomy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain Acute Pain Neuralgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lidocaine infusion

first group (lidocaine group) will include those who receive a intraoperative lidocaine infusion (Induction bolus dose of 1.5 mg/kg body weight followed by a continous lidocaine infusion

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

. Perioperatively, when lidocaine is administered as a continuous infusion at clinically relevant doses (1-2 mg/kg/hr) results in plasma concentration below 5µg.mL-1. At this plasma level, it is adequate to attenuate sympathetic responses , decrease pain and demonstrate a significant opioid sparing effect.

Saline Infusion

The second group will include those who receive a intraoperative placebo i(Induction bolus dose of 1.5 mg/kg body weight of lidocaine followed by a continous saline infusion at the same rate as the lidocaine infusion.

Group Type PLACEBO_COMPARATOR

Lidocaine

Intervention Type DRUG

. Perioperatively, when lidocaine is administered as a continuous infusion at clinically relevant doses (1-2 mg/kg/hr) results in plasma concentration below 5µg.mL-1. At this plasma level, it is adequate to attenuate sympathetic responses , decrease pain and demonstrate a significant opioid sparing effect.

Saline

Intervention Type DRUG

The second group will include those who receive a intraoperative placebo infusion(saline infusion) (Induction bolus dose of 1.5 mg/kg body weight followed by a continous saline infusion 1.5 mg/kg/hr.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lidocaine

. Perioperatively, when lidocaine is administered as a continuous infusion at clinically relevant doses (1-2 mg/kg/hr) results in plasma concentration below 5µg.mL-1. At this plasma level, it is adequate to attenuate sympathetic responses , decrease pain and demonstrate a significant opioid sparing effect.

Intervention Type DRUG

Saline

The second group will include those who receive a intraoperative placebo infusion(saline infusion) (Induction bolus dose of 1.5 mg/kg body weight followed by a continous saline infusion 1.5 mg/kg/hr.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* VATs for lobectomy
* Understanding of English (reading, writing and speaking)
* Written consent for being involved in this study

Exclusion Criteria

* Chronic pain including fibromyalgia
* Patients using opioids (more than 80 mg equivalent of oral morphine/day for \>60 days)
* Major depression
* Received or going to receive chemotherapy or radiotherapy.
* Pregnant

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No