Clinical trial NCT03666299: Lidocaine Infusion for Postthoracotomy Pain Syndrome
Official title: Lidocaine Infusion for Postthoracotomy Pain Syndrome, A Prospective, Randomized, Double-blind, Placebo-controlled Trial (LIPPS Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Surgery, Video-Assisted
Lidocaine
Pain, Postoperative
Chronic Pain
Keywords: postthoracotomy pain syndrome
chronic pain
lidocaine
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo a muscle-sparing lateral minithoracotomy for different thoracic diseases

Exclusion Criteria:

* (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

Primary outcomes:
measure: Occurrence of chronic pain
timeFrame: At 3 months after surgery.
Secondary outcomes:
measure: Postoperative acute pain
timeFrame: postoperative days 1 and 2.
measure: Sedation
timeFrame: postoperative days 1 and 2.
measure: Postoperative nausea and vomiting (PONV) nausea
timeFrame: postoperative days 1 and 2.
measure: Fatigue
timeFrame: postoperative days 1 and 2.
measure: Occurrence of chronic pain at 6-month
timeFrame: At 6 months after surgery.
Other outcomes:
measure: Postthoracotomy ipsilateral shoulder pain
timeFrame: postoperative days 1 and 2.
Locations:
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
Study officials:
affiliation: Affliated First People's Hospital of Guangzhou ,Guangzhou Medical University
name: Xiangcai Ruan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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