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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

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE September 17, 2018
Last Update Posted Date November 7, 2018
Actual Study Start Date  ICMJE November 6, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
Occurrence of chronic pain [ Time Frame: At 3 months after surgery. ]
Change History Complete list of historical versions of study NCT03673163 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
  • 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
  • Sedation [ Time Frame: Up to 48 hours after surgery ]
    Use an 0- to 10-point Numeric Rating Scale to asses
  • Postoperative nausea and vomiting (PONV) [ Time Frame: Up to 48 hours after surgery ]
    Use an 0- to 10-point Numeric Rating Scale to asses
  • Fatigue [ Time Frame: Up to 48 hours after surgery ]
    Use an 0- to 10-point Numeric Rating Scale to asses
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • 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
  • Sedation [ Time Frame: Up to 48 hours after surgery ]
    Use an 0- to 10-point Numeric Rating Scale to asses
  • Postoperative nausea and vomiting (PONV) [ Time Frame: Up to 48 hours after surgery ]
    Use an 0- to 10-point Numeric Rating Scale to asses
  • Fatigue [ Time Frame: Up to 48 hours after surgery ]
    Use an 0- to 10-point Numeric Rating Scale to asses
  • Chronic pain at 6-month after surgery [ Time Frame: At 6 months after surgery. ]
    Chronic pain was assessed in accordance with the IMMPACT recommends
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine Infusion for Pain After Herniotomy
Official Title  ICMJE Lidocaine Infusion for Pain After Herniotomy (LIPAH), A Randomized Placebo-controlled Trial (LIPAH Trial)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hernia, Inguinal
  • Lidocaine
  • Pain, Postoperative
  • Chronic Pain
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Lidocaine
    Lidocaine treatment
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Control
    Placebo treatment
    Intervention: Drug: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2018)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiangcai Ruan, PhD +8620-81048306 xc_ruan@hotmail.com
Contact: Danyang Pan, MD +86-13246886285 Pandy0505@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03673163
Other Study ID Numbers  ICMJE GZFPH-2018-115
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Guangzhou First People's Hospital
Study Sponsor  ICMJE Guangzhou First People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiangcai Ruan, PhD Affliated First People's Hospital of Guangzhou ,Guangzhou Medical University
PRS Account Guangzhou First People's Hospital
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP