Evidence map›Paper›PMID 38773653›Full record

ArticleTrials2024

Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial.

James S Khan, Ian Gilron, P J Devereaux, Hance Clarke, Nour Ayach, George Tomlinson, May Lynn Quan, Karim S Ladha, Stephen Choi, Allana Munro and 14 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04874038 (Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04874038 phase3recruitingnot on this map

Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)

TypeinterventionalSponsorUniversity Health Network, TorontoRan2021 to 2026Enrolled1,602ConditionsPost-mastectomy Pain Syndrome, Breast Cancer, Pain, Postoperative, Pain, ChronicArmsLidocaine 20mg/ml, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

James S KhanDepartment of Anesthesiology & Pain Medicine, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada. james.khan@medportal.ca.ORCID http://orcid.org/0000-0003-1210-7545
Ian GilronDepartments of Anesthesiology & Perioperative Medicine, and Biomedical & Molecular Sciences, Centre for Neuroscience Studies, and School of Policy Studies, Queen's University and Kingston Health Sciences Centre, Kingston, ON, Canada.
P J DevereauxPopulation Health Research Institute, McMaster University, Hamilton Health Sciences Corporation, Hamilton, ON, Canada.
Hance ClarkeDepartment of Anesthesiology and Pain Medicine, University of Toronto, Toronto, ON, Canada.
Nour AyachDepartment of Anesthesiology & Pain Medicine, University of Toronto, Toronto, ON, Canada.
George TomlinsonDepartment of Medicine, University Health Network and Mount Sinai Hospital, Toronto, ON, Canada.
May Lynn QuanDepartment of Surgery/Oncology, University of Calgary, Calgary, AB, Canada.
Karim S LadhaDepartment of Anesthesiology and Pain Medicine, University of Toronto, Toronto, ON, Canada.
Stephen ChoiDepartment of Anesthesiology and Pain Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Allana MunroDepartment of Anesthesia, Pain Management, and Perioperative Medicine, Dalhousie University, Halifax, NS, Canada.
Richard BrullDepartment of Anesthesiology and Pain Medicine, Women's College Hospital, University of Toronto, Toronto, ON, Canada.
David W LimWomen's College Research Institute & Department Surgery, Women's College Hospital, Toronto, ON, Canada.
Sinziana AvramescuDepartment of Anesthesiology and Pain Medicine, Humber River Hospital, University of Toronto, Toronto, ON, Canada.
Philippe RichebéDepartment of Anesthesiology and Pain Medicine, Maisonneuve-Rosemont Hospital, CIUSSS de L'Est de L'Ile de Montreal (CEMTL), University of Montreal, Montreal, QC, Canada.
Nicole HodgsonDepartment of Surgery, McMaster University, Hamilton, ON, Canada.
James PaulDepartment of Anesthesia, McMaster University, Hamilton, ON, Canada.
Daniel I McIsaacDepartments of Anesthesiology & Pain Medicine and School of Epidemiology & Public Health, The Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada.
Simone DerziDepartment of Anesthesiology & Pain Medicine, University of Alberta, Edmonton, AB, Canada.
Geoff L ZbitnewDepartment of Anesthesiology, Memorial University, St. John's, NF, Canada.
Alexandra M EassonDepartment of Surgery and Institute of Health, Policy, Management and Evaluation (HPME), Mount Sinai Hospital and Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
Naveed T SiddiquiDepartment of Anesthesiology & Pain Medicine, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.
Sarah J MilesDepartment of Anesthesia and Pain Medicine, University of Toronto, Toronto, ON, Canada.
Keyvan KarkoutiDepartment of Anesthesia and Pain Medicine, University of Toronto, Toronto, ON, Canada.
PLAN Trial Investigators

Funding

Canadian Anesthesia Research Foundation CAS-2021-041CIHR 438823Rising Tide Foundation for Clinical Cancer Research CCR-23-900
6 · The paper itself

Abstract

backgroundPersistent pain is a common yet debilitating complication after breast cancer surgery. Given the pervasive effects of this pain disorder on the patient and healthcare system, post-mastectomy pain syndrome (PMPS) is becoming a larger population health problem, especially as the prognosis and survivorship of breast cancer increases. Interventions that prevent persistent pain after breast surgery are needed to improve the quality of life of breast cancer survivors. An intraoperative intravenous lidocaine infusion has emerged as a potential intervention to decrease the incidence of PMPS. We aim to determine the definitive effects of this intervention in patients undergoing breast cancer surgery.

methodsPLAN will be a multicenter, parallel-group, blinded, 1:1 randomized, placebo-controlled trial of 1,602 patients undergoing breast cancer surgery. Adult patients scheduled for a lumpectomy or mastectomy will be randomized to receive an intravenous 2% lidocaine bolus of 1.5 mg/kg with induction of anesthesia, followed by a 2.0 mg/kg/h infusion until the end of surgery, or placebo solution (normal saline) at the same volume. The primary outcome will be the incidence of persistent pain at 3 months. Secondary outcomes include the incidence of pain and opioid consumption at 1 h, 1-3 days, and 12 months after surgery, as well as emotional, physical, and functional parameters, and cost-effectiveness. DISCUSSION: This trial aims to provide definitive evidence on an intervention that could potentially prevent persistent pain after breast cancer surgery. If this trial is successful, lidocaine infusion would be integrated as standard of care in breast cancer management. This inexpensive, widely available, and easily administered intervention has the potential to reduce pain and suffering in an already afflicted patient population, decrease the substantial costs of chronic pain management, potentially decrease opioid use, and improve the quality of life in patients.

trial registrationThis trial has been registered on clinicaltrials.gov (NCT04874038, Dr. James Khan. Date of registration: May 5, 2021).

Indexed as

Anesthetics, LocalBreast NeoplasmsLidocaineMastectomyMulticenter Studies as TopicPostoperative PainRandomized Controlled Trials as TopicAnalgesics, OpioidChronic PainCost-Benefit AnalysisFemaleHumansInfusions, IntravenousMastectomy, SegmentalPain MeasurementQuality of LifeAnalgesics, OpioidAnesthetics, LocalLidocaineBreast cancer surgeryChronic painChronic postsurgical painLidocaine infusionPerioperative carePost-mastectomy pain syndrome

Identifiers

PMID38773653
PMCPMC11110187

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.