Lidocaine Infusion for Postthoracotomy Pain Syndrome
- Conditions
- Chronic PainThoracic Surgery, Video-AssistedLidocainePain, Postoperative
- Interventions
- Drug: Control
- Registration Number
- NCT03666299
- Lead Sponsor
- Guangzhou First People's Hospital
- Brief Summary
This study seeks to investigate lidocaine infusion to reduce postthoractomy pain syndrome after thoracic Surgery
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 72
- Patients scheduled to undergo a muscle-sparing lateral minithoracotomy for different thoracic diseases
- (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
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 acute pain postoperative days 1 and 2. Use numeric rating scale (NRS) to assess the postoperative acute pain
Sedation postoperative days 1 and 2. Use numeric rating scale (NRS) to asses
Postoperative nausea and vomiting (PONV) nausea postoperative days 1 and 2. Use numeric rating scale (NRS) to assess
Fatigue postoperative days 1 and 2. Use numeric rating scale (NRS) to assess
Occurrence of chronic pain at 6-month 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.
Trial Locations
- Locations (1)
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China