Lidocaine Infusion for Postthoracotomy Pain Syndrome

Study Overview
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Brief Summary
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This study seeks to investigate lidocaine infusion to reduce postthoractomy pain syndrome after thoracic Surgery

Detailed Description
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Postthoracotomy pain syndrome (PPS) is defined as a persistent and/or recurrent pain or burning sensation along the thoracotomy scar at 3 months after surgery. The pain is very significant, given that 3 to 5% of postthoractomy patients report it as being severe, and approximately 50% of patients report limitations in their activities of daily living. Little is known about the origin of this pain, but it seems that the intensity of acute postoperative pain is the best predictor of it. Lidocaine infusion could be a possible approach to reducing the prevalence of PPS. Recently, a meta-analysis concluded a modest but statistically significant reduction of pain severity in the first four postoperative hours measured by the visual analogue scale (mean difference, -0.84; 95% CI, -1.10 to -0.59). However, a more recent meta-analysis found that only limited clinical data and biological plausibility support lidocaine infusions for the prevention of postoperative persistent pain (odds ratio, 0.29; 95% CI, 0.18 to 0.48). This study was designed to investigate whether lidocaine infusion after video-assisted thoracoscopic surgery (VATS) would lower PPS at postoperative 3 and 6 month.

Official Title
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Lidocaine Infusion for Postthoracotomy Pain Syndrome, A Prospective, Randomized, Double-blind, Placebo-controlled Trial (LIPPS Trial)

Conditions
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Thoracic Surgery, Video-Assisted, Lidocaine, Pain, Postoperative, Chronic Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo a muscle-sparing lateral minithoracotomy for different thoracic diseases Exclusion Criteria: (1)ASA classification status III or above (2)Body weight<35kg (3)Liver cirrhosis (4)A history of previous thoracotomy (5)Pregnancy (6)Severe arrhythmia (7)Congestive heart failure (8)Opioid or steroid use 6 months before surgery (9)Allergy to lidocaine (10)Chronic pain syndrome (any type) (11)Emergency surgery (12)Incapacity to give an informed consent, Visual dysfunction or severe mental disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>Lidocaine treatment | Drug: Lidocaine<br>* Infusion of 2% lidocaine hydrochloride at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.<br>* Other names: intravenous lidocaine infusion;|
| Placebo Comparator: Control<br>Placebo treatment | Drug: Control<br>* Infusion of normal saline at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.<br>* Other names: normal saline control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of chronic pain | Chronic pain was assessed in accordance with the IMMPACT recommends in the domains of: (1) absence or presence of pain in the area of the surgery, (2) clinically important (NRS ≥ 4 on a 0- to 10-point scale) daily average pain, (3) clinically important pain at rest, (4) clinically important pain intensity upon movement or activity, (5) pain qualities, and (6) physical and emotional functioning. | At 3 months after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative acute pain | Use numeric rating scale (NRS) to assess the postoperative acute pain | postoperative days 1 and 2. | 
| Sedation | Use numeric rating scale (NRS) to asses | postoperative days 1 and 2. | 
| Postoperative nausea and vomiting (PONV) nausea | Use numeric rating scale (NRS) to assess | postoperative days 1 and 2. | 
| Fatigue | Use numeric rating scale (NRS) to assess | postoperative days 1 and 2. | 
| Occurrence of chronic pain at 6-month | Chronic pain was assessed in accordance with the IMMPACT recommends in the domains of: (1) absence or presence of pain in the area of the surgery, (2) clinically important (NRS ≥ 4 on a 0- to 10-point scale) daily average pain, (3) clinically important pain at rest, (4) clinically important pain intensity upon movement or activity, (5) pain qualities, and (6) physical and emotional functioning. | At 6 months after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, lidocaine, postthoracotomy pain syndrome