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Lidocaine Infusion for Pain After Herniotomy (LIPAH)

Primary Purpose

Hernia, Inguinal, Lidocaine, Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lidocaine
Control
Sponsored by
Guangzhou First People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring chronic postoperative pain, lidocaine infusion, inguinal herniotomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangzhou First People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine

Control

Arm Description

Lidocaine treatment

Placebo treatment

Outcomes

Primary Outcome Measures

Occurrence of chronic pain
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

Postoperative acute pain
Use an 11-point Numeric Rating Scale (NRS) to assess the postoperative acute pain
Sedation
Use an 0- to 10-point Numeric Rating Scale to asses
Postoperative nausea and vomiting (PONV)
Use an 0- to 10-point Numeric Rating Scale to asses
Fatigue
Use an 0- to 10-point Numeric Rating Scale to asses
Chronic pain at 6-month 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
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.

Full Information

First Posted
September 12, 2018
Last Updated
November 5, 2018
Sponsor
Guangzhou First People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03673163
Brief Title
Lidocaine Infusion for Pain After Herniotomy
Acronym
LIPAH
Official Title
Lidocaine Infusion for Pain After Herniotomy (LIPAH), A Randomized Placebo-controlled Trial (LIPAH Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou First People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal, Lidocaine, Pain, Postoperative, Chronic Pain
Keywords
chronic postoperative pain, lidocaine infusion, inguinal herniotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Lidocaine treatment
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo treatment
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
intravenous lidocaine infusion
Intervention Description
Infusion of 2% lidocaine hydrochloride at 4 mL/h,prior to surgery and discontinued until 24 h after surgery.
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
normal saline control
Intervention Description
Infusion of normal saline at 4 mL/h, prior to surgery and discontinued until 24 h after surgery.
Primary Outcome Measure Information:
Title
Occurrence of chronic pain
Description
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.
Time Frame
At 3 months after surgery.
Secondary Outcome Measure Information:
Title
Postoperative acute pain
Description
Use an 11-point Numeric Rating Scale (NRS) to assess the postoperative acute pain
Time Frame
Up to 48 hours after surgery
Title
Sedation
Description
Use an 0- to 10-point Numeric Rating Scale to asses
Time Frame
Up to 48 hours after surgery
Title
Postoperative nausea and vomiting (PONV)
Description
Use an 0- to 10-point Numeric Rating Scale to asses
Time Frame
Up to 48 hours after surgery
Title
Fatigue
Description
Use an 0- to 10-point Numeric Rating Scale to asses
Time Frame
Up to 48 hours after surgery
Title
Chronic pain at 6-month after surgery
Description
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.
Time Frame
At 6 months after surgery.
Title
Chronic pain at 12-month after surgery
Description
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.
Time Frame
At 12 months after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangcai Ruan, PhD
Phone
+8620-81048306
Email
xc_ruan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Danyang Pan, MD
Phone
+86-13246886285
Email
Pandy0505@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangcai Ruan, PhD
Organizational Affiliation
Affliated First People's Hospital of Guangzhou ,Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Luo
Phone
020-81045412
Email
MEC_GZSY@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28115872
Citation
Wang JL, Zhang WJ, Gao M, Zhang S, Tian DH, Chen J. A cross-cultural adaptation and validation of the short-form McGill Pain Questionnaire-2: Chinese version in patients with chronic visceral pain. J Pain Res. 2017 Jan 5;10:121-128. doi: 10.2147/JPR.S116997. eCollection 2017.
Results Reference
background
PubMed Identifier
26184397
Citation
Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2.
Results Reference
background
PubMed Identifier
29757886
Citation
Bailey M, Corcoran T, Schug S, Toner A. Perioperative lidocaine infusions for the prevention of chronic postsurgical pain: a systematic review and meta-analysis of efficacy and safety. Pain. 2018 Sep;159(9):1696-1704. doi: 10.1097/j.pain.0000000000001273.
Results Reference
background
PubMed Identifier
20207481
Citation
Dworkin RH, Turk DC, Peirce-Sandner S, Baron R, Bellamy N, Burke LB, Chappell A, Chartier K, Cleeland CS, Costello A, Cowan P, Dimitrova R, Ellenberg S, Farrar JT, French JA, Gilron I, Hertz S, Jadad AR, Jay GW, Kalliomaki J, Katz NP, Kerns RD, Manning DC, McDermott MP, McGrath PJ, Narayana A, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Reeve BB, Rhodes T, Sampaio C, Simpson DM, Stauffer JW, Stucki G, Tobias J, White RE, Witter J. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations. Pain. 2010 May;149(2):177-193. doi: 10.1016/j.pain.2010.02.018. Epub 2010 Mar 6.
Results Reference
background
PubMed Identifier
15531621
Citation
Aasvang E, Kehlet H. Chronic postoperative pain: the case of inguinal herniorrhaphy. Br J Anaesth. 2005 Jul;95(1):69-76. doi: 10.1093/bja/aei019. Epub 2004 Nov 5. No abstract available.
Results Reference
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Lidocaine Infusion for Pain After Herniotomy

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