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Hernia, InguinalLIPAHNCT03673163

Lidocaine Infusion for Pain After Herniotomy

A study testing Lidocaine in people with Hernia, Inguinal and Lidocaine, run by Guangzhou First People's Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hernia, Inguinal, Lidocaine, Pain, Postoperative
What is being tested?
Lidocaine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteChina
Study dates
6 Nov 2018to 30 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients scheduled to undergo unilateral inguino herniotomy

Who cannot join

  • (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
Show all 12Show fewer
  • (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

Trial locations and contacts

1 site in 1 country.

Xiangcai Ruan, PhD contact

+8620-81048306

xc_ruan@hotmail.com

Danyang Pan, MD contact

+86-13246886285

Pandy0505@163.com

China1 site, 1 recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

    Yu Luo, 020-81045412, MEC_GZSY@163.com

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
Lidocaine, Control
Keywords
chronic postoperative pain, lidocaine infusion, inguinal herniotomy
Medical subject headings
Hernia, Inguinal, Pain, Postoperative, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidocaineDrug

    Also called intravenous lidocaine infusion

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

  • ControlDrug

    Also called normal saline control

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

Study groups in NCT03673163
Study groupRoleWhat they receive
LidocaineExperimentalLidocaine treatment
Receives: Drug: Lidocaine
ControlPlacebo comparatorPlacebo treatment
Receives: Drug: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 3 months after surgery.

Secondary outcomes (6)

  1. Postoperative acute pain

    Use an 11-point Numeric Rating Scale (NRS) to assess the postoperative acute pain

    Measured: Up to 48 hours after surgery

  2. Sedation

    Use an 0- to 10-point Numeric Rating Scale to asses

    Measured: Up to 48 hours after surgery

  3. Postoperative nausea and vomiting (PONV)

    Use an 0- to 10-point Numeric Rating Scale to asses

    Measured: Up to 48 hours after surgery

  4. Fatigue

    Use an 0- to 10-point Numeric Rating Scale to asses

    Measured: Up to 48 hours after surgery

  5. 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.

    Measured: At 6 months after surgery.

  6. 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.

    Measured: At 12 months after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2018
  2. Study start6 Nov 2018
  3. Primary completion30 Jun 2019 (estimated)
  4. Study completion30 Jun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03673163
Sponsor's protocol ID
GZFPH-2018-115
Acronym
LIPAH
Status last verified
Nov 2018
First submitted
12 Sep 2018
Last updated
7 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28115872

  • 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.

    PubMed 26184397

  • 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.

    PubMed 29757886

  • 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.

    PubMed 20207481

  • 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.

    PubMed 15531621

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine in people with Hernia, Inguinal and Lidocaine, run by Guangzhou First People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiangcai Ruan, PhD (+8620-81048306, xc_ruan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of chronic pain (time frame: At 3 months after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03673163, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.

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