Lidocaine Infusion for Pain After Herniotomy (LIPAH)

Guangzhou First People's Hospital

Status: Unknown

Conditions: Hernia, Inguinal; Chronic Pain; Lidocaine; Pain, Postoperative

Treatments: Drug: Control; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03673163

GZFPH-2018-115

Details and patient eligibility

About

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

Full description

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

Lidocaine

Experimental group

Description:

Lidocaine treatment

Treatment:

Drug: Lidocaine

Control

Placebo Comparator group

Description:

Placebo treatment

Treatment:

Drug: Control