Lidocaine Infusion for Pain After Herniotomy

Study Overview
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Brief Summary
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This study seeks to investigate lidocaine infusion to reduce occurrence of chronic postoperative pain at 3-month after inguinal herniotomy

Detailed Description
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Inguinal hernia repair is associated with a 5%-30% incidence of chronic pain; however, the pathogenesis remains unknown, and few studies have assessed chronic pain as the primary aim of the study. Lidocaine infusion could be a possible approach to reducing the prevalence of chronic pain after herniotomy. 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 inguinal herniotomy would lower the incidence of chronic postoperative pain.

Official Title
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Lidocaine Infusion for Pain After Herniotomy (LIPAH), A Randomized Placebo-controlled Trial (LIPAH Trial)

Conditions
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Hernia, Inguinal, 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 unilateral inguino herniotomy Exclusion Criteria: (1)ASA classification status III or above (2)Body weight<35kg (3)Liver cirrhosis (4)A history of previous herniotomy (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,prior to surgery 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, prior to surgery 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 an 11-point Numeric Rating Scale (NRS) to assess the postoperative acute pain | Up to 48 hours after surgery | 
| Sedation | Use an 0- to 10-point Numeric Rating Scale to asses | Up to 48 hours after surgery | 
| Postoperative nausea and vomiting (PONV) | Use an 0- to 10-point Numeric Rating Scale to asses | Up to 48 hours after surgery | 
| Fatigue | Use an 0- to 10-point Numeric Rating Scale to asses | Up to 48 hours after surgery | 
| Chronic pain at 6-month after surgery | 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. | 
| Chronic pain at 12-month after surgery | 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 12 months after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic postoperative pain, lidocaine infusion, inguinal herniotomy