Clinical trial NCT03673163: Lidocaine Infusion for Pain After Herniotomy
Official title: Lidocaine Infusion for Pain After Herniotomy (LIPAH), A Randomized Placebo-controlled Trial (LIPAH Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Lidocaine
Pain, Postoperative
Chronic Pain
Keywords: chronic postoperative pain
lidocaine infusion
inguinal herniotomy
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 180
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 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.

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

Primary outcomes:
measure: Occurrence of chronic pain
timeFrame: At 3 months after surgery.
Secondary outcomes:
measure: Postoperative acute pain
timeFrame: Up to 48 hours after surgery
measure: Sedation
timeFrame: Up to 48 hours after surgery
measure: Postoperative nausea and vomiting (PONV)
timeFrame: Up to 48 hours after surgery
measure: Fatigue
timeFrame: Up to 48 hours after surgery
measure: Chronic pain at 6-month after surgery
timeFrame: At 6 months after surgery.
measure: Chronic pain at 12-month after surgery
timeFrame: At 12 months after surgery.
Other outcomes:
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:
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.
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.
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.
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.
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.