Chronic Pain, Hernia, Inguinal, Lidocaine, Pain, Postoperative
Conditions
Keywords
chronic postoperative pain, lidocaine infusion, inguinal herniotomy
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.
Interventions
DRUGLidocaine
Infusion of 2% lidocaine hydrochloride at 4 mL/h,prior to surgery and discontinued until 24 h after surgery.
DRUGControl
Infusion of normal saline at 4 mL/h, prior to surgery and discontinued until 24 h after surgery.
Sponsors
Guangzhou First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Up to 48 hours after surgery | Use an 0- to 10-point Numeric Rating Scale to asses |
| Sedation | Up to 48 hours after surgery | Use an 0- to 10-point Numeric Rating Scale to asses |
| Postoperative nausea and vomiting (PONV) | 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. |
| Postoperative acute pain | Up to 48 hours after surgery | Use an 11-point Numeric Rating Scale (NRS) to assess the postoperative acute pain |
Countries
China
Contacts
Primary ContactXiangcai Ruan, PhD
Backup ContactDanyang Pan, MD
Outcome results
None listed