Lidocaine Infusion for Pain After Herniotomy

Chronic Pain Clinical Trial

— LIPAH  

Official title:

Lidocaine Infusion for Pain After Herniotomy (LIPAH), A Randomized Placebo-controlled Trial (LIPAH Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03673163
• Other study ID #: GZFPH-2018-115
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: November 2018
• Source: Guangzhou First People's Hospital
• Contact: Xiangcai Ruan, PhD
• Phone: +8620-81048306
• Email: xc_ruan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to investigate lidocaine infusion to reduce occurrence of chronic postoperative pain at 3-month after inguinal herniotomy

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Hernia, Inguinal
• Lidocaine
• Pain, Postoperative

Intervention

Drug:
• Lidocaine
Infusion of 2% lidocaine hydrochloride at 4 mL/h,prior to surgery and discontinued until 24 h after surgery.
• Control
Infusion of normal saline at 4 mL/h, prior to surgery and discontinued until 24 h after surgery.

Locations

Country	Name	City	State
China	Guangzhou First People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Aasvang E, Kehlet H. Chronic postoperative pain: the case of inguinal herniorrhaphy. Br J Anaesth. 2005 Jul;95(1):69-76. Epub 2004 Nov 5. Review. — View 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. — View 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, Kalliomäki 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):177-93. doi: 10.1016/j.pain.2010.02.018. Epub 2010 Mar 6. Review. — View 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. Review. Update in: Cochrane Database Syst Rev. 2018 Jun 04;6:CD009642. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 3 months after surgery.
Secondary	Postoperative acute pain	Use an 11-point Numeric Rating Scale (NRS) to assess the postoperative acute pain	Up to 48 hours after surgery
Secondary	Sedation	Use an 0- to 10-point Numeric Rating Scale to asses	Up to 48 hours after surgery
Secondary	Postoperative nausea and vomiting (PONV)	Use an 0- to 10-point Numeric Rating Scale to asses	Up to 48 hours after surgery
Secondary	Fatigue	Use an 0- to 10-point Numeric Rating Scale to asses	Up to 48 hours after surgery
Secondary	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.	At 6 months after surgery.
Secondary	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.	At 12 months after surgery.