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Lidocaine Infusion for Postthoracotomy Pain Syndrome (LIPPS)

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ClinicalTrials.gov Identifier: NCT03666299
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Guangzhou First People's Hospital

Brief Summary:
This study seeks to investigate lidocaine infusion to reduce postthoractomy pain syndrome after thoracic Surgery

Condition or disease Intervention/treatment Phase
Thoracic Surgery, Video-Assisted Lidocaine Pain, Postoperative Chronic Pain Drug: Lidocaine Drug: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lidocaine Infusion for Postthoracotomy Pain Syndrome, A Prospective, Randomized, Double-blind, Placebo-controlled Trial (LIPPS Trial)
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Lidocaine
Lidocaine treatment
Drug: Lidocaine
Infusion of 2% lidocaine hydrochloride at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.
Other Name: intravenous lidocaine infusion

Placebo Comparator: Control
Placebo treatment
Drug: Control
Infusion of normal saline at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.
Other Name: normal saline control




Primary Outcome Measures :
  1. Occurrence of chronic pain [ Time Frame: 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 :
  1. Postoperative acute pain [ Time Frame: postoperative days 1 and 2. ]
    Use numeric rating scale (NRS) to assess the postoperative acute pain

  2. Sedation [ Time Frame: postoperative days 1 and 2. ]
    Use numeric rating scale (NRS) to asses

  3. Postoperative nausea and vomiting (PONV) nausea [ Time Frame: postoperative days 1 and 2. ]
    Use numeric rating scale (NRS) to assess

  4. Fatigue [ Time Frame: postoperative days 1 and 2. ]
    Use numeric rating scale (NRS) to assess

  5. Occurrence of chronic pain at 6-month [ Time Frame: 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.


Other Outcome Measures:
  1. Postthoracotomy ipsilateral shoulder pain [ Time Frame: postoperative days 1 and 2. ]
    Use numeric rating scale (NRS) to assess



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666299


Contacts
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Contact: Xiangcai Ruan, PhD +8620-81048306 xc_ruan@hotmail.com
Contact: Danyang Pan, MD +86-13246886285 Pandy0505@163.com

Locations
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China, Guangdong
Guangzhou First People's Hospital Recruiting
Guangzhou, Guangdong, China, 510180
Contact: Yu Luo, MD    020-81045412    MEC_GZSY@163.com   
Sponsors and Collaborators
Guangzhou First People's Hospital
Investigators
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Principal Investigator: Xiangcai Ruan, PhD Affliated First People's Hospital of Guangzhou ,Guangzhou Medical University

Publications:

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Responsible Party: Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Professor, Guangzhou First People's Hospital
ClinicalTrials.gov Identifier: NCT03666299    
Other Study ID Numbers: GZFPH-2018-114
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Guangzhou First People's Hospital:
postthoracotomy pain syndrome
chronic pain
lidocaine
Additional relevant MeSH terms:
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Chronic Pain
Pain, Postoperative
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Postoperative Complications
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action