Lidocaine Infusion for Pain After Herniotomy
- Conditions
- Chronic PainHernia, InguinalLidocainePain, Postoperative
- Interventions
- Drug: Control
- Registration Number
- NCT03673163
- Lead Sponsor
- Guangzhou First People's Hospital
- Brief Summary
This study seeks to investigate lidocaine infusion to reduce occurrence of chronic postoperative pain at 3-month after inguinal herniotomy
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- Patients scheduled to undergo unilateral inguino herniotomy
- (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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control Placebo treatment Lidocaine Lidocaine Lidocaine treatment
- Primary Outcome Measures
Name Time Method Occurrence of chronic pain At 3 months 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.
- Secondary Outcome Measures
Name Time Method Postoperative nausea and vomiting (PONV) Up to 48 hours after surgery Use an 0- to 10-point Numeric Rating Scale to asses
Postoperative acute pain Up to 48 hours after surgery Use an 11-point Numeric Rating Scale (NRS) to assess the postoperative acute pain
Sedation Up to 48 hours after surgery Use an 0- to 10-point Numeric Rating Scale to asses
Fatigue Up to 48 hours after surgery Use an 0- to 10-point Numeric Rating Scale to asses
Chronic pain at 6-month after surgery At 6 months 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.
Chronic pain at 12-month after surgery At 12 months 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.
Trial Locations
- Locations (1)
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China