Lidocaine Infusion for Pain After Herniotomy

NCT03673163 | Unknown

• 1 other identifier: GZFPH-2018-115
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hernia, Inguinal; Lidocaine; Pain, Postoperative; Chronic Pain

Keywords

chronic postoperative pain; lidocaine infusion; inguinal herniotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Postoperative acute pain

  Up to 48 hours after surgery

• Sedation

  Up to 48 hours after surgery

• Postoperative nausea and vomiting (PONV)

  Up to 48 hours after surgery

• Fatigue

  Up to 48 hours after surgery

• Chronic pain at 6-month after surgery

  At 6 months after surgery.

Study Arms (2)

Lidocaine

EXPERIMENTAL

Lidocaine treatment

Drug: Lidocaine

Control

PLACEBO COMPARATOR

Placebo treatment

Drug: Control

Interventions

Lidocaine DRUG

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

Also known as: intravenous lidocaine infusion

Lidocaine

Control DRUG

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

Also known as: normal saline control

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo unilateral inguino herniotomy

You may not qualify if:

• (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

Sponsors & Collaborators

• Guangzhou First People's Hospital: lead

Study Sites (1)

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 28115872 BACKGROUND

• 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.

  PMID: 26184397 BACKGROUND

• 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.

  PMID: 29757886 BACKGROUND

• 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.

  PMID: 20207481 BACKGROUND

• 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.

  PMID: 15531621 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative; Chronic Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Xiangcai Ruan, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangcai Ruan, PhD

CONTACT

+8620-81048306; xc_ruan@hotmail.com

Danyang Pan, MD

CONTACT

+86-13246886285; Pandy0505@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 17, 2018
• Study Start: November 6, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)