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Lidocaine Infusion for Pain After Herniotomy (LIPAH)

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ClinicalTrials.gov Identifier: NCT03673163
Recruitment Status : Recruiting
First Posted : September 17, 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 occurrence of chronic postoperative pain at 3-month after inguinal herniotomy

Condition or disease Intervention/treatment Phase
Hernia, Inguinal Lidocaine Pain, Postoperative Chronic Pain Drug: Lidocaine Drug: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lidocaine Infusion for Pain After Herniotomy (LIPAH), A Randomized Placebo-controlled Trial (LIPAH 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,prior to surgery 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, prior to surgery 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: Up to 48 hours after surgery ]
    Use an 11-point Numeric Rating Scale (NRS) to assess the postoperative acute pain

  2. Sedation [ Time Frame: Up to 48 hours after surgery ]
    Use an 0- to 10-point Numeric Rating Scale to asses

  3. Postoperative nausea and vomiting (PONV) [ Time Frame: Up to 48 hours after surgery ]
    Use an 0- to 10-point Numeric Rating Scale to asses

  4. Fatigue [ Time Frame: Up to 48 hours after surgery ]
    Use an 0- to 10-point Numeric Rating Scale to asses

  5. Chronic pain at 6-month after surgery [ 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.

  6. Chronic pain at 12-month after surgery [ Time Frame: 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.



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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 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

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): NCT03673163


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    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: NCT03673163     History of Changes
Other Study ID Numbers: GZFPH-2018-115
First Posted: September 17, 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:
chronic postoperative pain
lidocaine infusion
inguinal herniotomy
Additional relevant MeSH terms:
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Chronic Pain
Pain, Postoperative
Hernia, Inguinal
Pain
Neurologic Manifestations
Signs and Symptoms
Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Hernia, Abdominal
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