Lidocaine Infusion for Pain After Herniotomy

NCT ID: NCT03673163

Last Updated: 2018-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-06

Study Completion Date

2019-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Hernia, Inguinal Lidocaine Pain, Postoperative Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine

Lidocaine treatment

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Infusion of 2% lidocaine hydrochloride at 4 mL/h,prior to surgery and discontinued until 24 h after surgery.

Control

Placebo treatment

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

Infusion of normal saline at 4 mL/h, prior to surgery and discontinued until 24 h after surgery.

Interventions

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Lidocaine

Infusion of 2% lidocaine hydrochloride at 4 mL/h,prior to surgery and discontinued until 24 h after surgery.

Intervention Type DRUG

Control

Infusion of normal saline at 4 mL/h, prior to surgery and discontinued until 24 h after surgery.

Intervention Type DRUG

Other Intervention Names

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intravenous lidocaine infusion normal saline control

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou First People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiangcai Ruan, PhD

Role: PRINCIPAL_INVESTIGATOR

Affliated First People's Hospital of Guangzhou ,Guangzhou Medical University

Locations

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Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangcai Ruan, PhD

Role: CONTACT

+8620-81048306

Danyang Pan, MD

Role: CONTACT

+86-13246886285

Facility Contacts

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Yu Luo

Role: primary

020-81045412

References

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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.

Reference Type BACKGROUND
PMID: 28115872 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26184397 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29757886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20207481 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15531621 (View on PubMed)

Other Identifiers

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GZFPH-2018-115

Identifier Type: -

Identifier Source: org_study_id

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