NCT04398316

Brief Summary

Intravenous lidocaine will be given at a dose of 2 mg/kg intravenously to patients in the emergency department with a diagnosis of acute abdominal pain. Its efficacy will be compared to 1 mg of intravenous hydromorphone, with a primary endpoint of mean improvement of pain at 90 minutes.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

February 18, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

January 17, 2024

Completed
Last Updated

January 17, 2024

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

May 7, 2020

Results QC Date

September 6, 2022

Last Update Submit

December 26, 2023

Conditions

Abdominal PainRenal Colic

Keywords

lidocainehydromorphoneabdominal pain

Outcome Measures

Primary Outcomes (1)

  • Mean Improvement in Pain at 90 Minutes

    The difference between the pain score at time 0 and 90 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).

    90 minutes

Secondary Outcomes (14)

  • Sufficient Pain Relief

    From administration of study drug until patient leaves the emergency department, up until 3 hours from administration of study drug.

  • Improvement in Numerical Pain Score at 15 Minutes

    15 minutes

  • Improvement in Numerical Pain Score at 30 Minutes

    30 minutes

  • Improvement in Numerical Pain Score at 60 Minutes

    60 minutes

  • Improvement in Numerical Pain Score at 120 Minutes

    120 minutes

  • +9 more secondary outcomes

Study Arms (2)

Intravenous Lidocaine

EXPERIMENTAL

Administered at a dose of 2 mg/kg over 5 minutes

Drug: Lidocaine Iv

Intravenous Hydromorphone

ACTIVE COMPARATOR

Administered at a dose of 1 mg over 5 minutes

Drug: HYDROmorphone Injection

Interventions

Lidocaine IvDRUG

2 mg/kg over 5 minutes

Also known as: Xylocaine
Intravenous Lidocaine
HYDROmorphone InjectionDRUG

1 mg over 5 minutes

Also known as: Dilaudid
Intravenous Hydromorphone

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must be a patient in the emergency department (ED)
  • Must have acute abdominal pain, defined as abdominal or flank pain of a duration of 7 days or less
  • Predicted treatment must include the use of an intravenous opiate

You may not qualify if:

  • Cardiac conduction system impairment (QTc duration \> 0.5s, QRS duration \> 0.12s, PR interval \<0.12s or \> 0.2s)
  • Known renal (CKD \>2) or liver disease (Childs-Pugh B or greater)
  • Hemodynamically instability, defined by the attending physician
  • Pregnant or breastfeeding
  • Have a known allergy to either medication
  • Used of prescription or illicit opioids within the previous week
  • Patients with a chronic pain disorder, defined as use of any analgesic medication on more days than not during the four weeks preceding the acute episode of pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (13)

  • Tremont-Lukats IW, Challapalli V, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetics to relieve neuropathic pain: a systematic review and meta-analysis. Anesth Analg. 2005 Dec;101(6):1738-1749. doi: 10.1213/01.ANE.0000186348.86792.38.

    PMID: 16301253BACKGROUND

  • 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: 26184397BACKGROUND

  • Ventham NT, Kennedy ED, Brady RR, Paterson HM, Speake D, Foo I, Fearon KC. Efficacy of Intravenous Lidocaine for Postoperative Analgesia Following Laparoscopic Surgery: A Meta-Analysis. World J Surg. 2015 Sep;39(9):2220-34. doi: 10.1007/s00268-015-3105-6.

    PMID: 26044546BACKGROUND

  • Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8.

    PMID: 23044681BACKGROUND

  • Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.

    PMID: 21061107BACKGROUND

  • Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375.

    PMID: 18844267BACKGROUND

  • Fitzpatrick BM, Mullins ME. Intravenous lidocaine for the treatment of acute pain in the emergency department. Clin Exp Emerg Med. 2016 Jun 30;3(2):105-108. doi: 10.15441/ceem.15.103. eCollection 2016 Jun.

    PMID: 27752626BACKGROUND

  • Soleimanpour H, Hassanzadeh K, Mohammadi DA, Vaezi H, Esfanjani RM. Parenteral lidocaine for treatment of intractable renal colic: a case series. J Med Case Rep. 2011 Jun 29;5:256. doi: 10.1186/1752-1947-5-256.

    PMID: 21714904BACKGROUND

  • Soleimanpour H, Hassanzadeh K, Vaezi H, Golzari SE, Esfanjani RM, Soleimanpour M. Effectiveness of intravenous lidocaine versus intravenous morphine for patients with renal colic in the emergency department. BMC Urol. 2012 May 4;12:13. doi: 10.1186/1471-2490-12-13.

    PMID: 22559856BACKGROUND

  • Firouzian A, Alipour A, Rashidian Dezfouli H, Zamani Kiasari A, Gholipour Baradari A, Emami Zeydi A, Amini Ahidashti H, Montazami M, Hosseininejad SM, Yazdani Kochuei F. Does lidocaine as an adjuvant to morphine improve pain relief in patients presenting to the ED with acute renal colic? A double-blind, randomized controlled trial. Am J Emerg Med. 2016 Mar;34(3):443-8. doi: 10.1016/j.ajem.2015.11.062. Epub 2015 Dec 1.

    PMID: 26704774BACKGROUND

  • Vahidi E, Shakoor D, Aghaie Meybodi M, Saeedi M. Comparison of intravenous lidocaine versus morphine in alleviating pain in patients with critical limb ischaemia. Emerg Med J. 2015 Jul;32(7):516-9. doi: 10.1136/emermed-2014-203944. Epub 2014 Aug 21.

    PMID: 25147364BACKGROUND

  • Clattenburg EJ, Nguyen A, Yoo T, Flores S, Hailozian C, Louie D, Herring AA. Intravenous Lidocaine Provides Similar Analgesia to Intravenous Morphine for Undifferentiated Severe Pain in the Emergency Department: A Pilot, Unblinded Randomized Controlled Trial. Pain Med. 2019 Apr 1;20(4):834-839. doi: 10.1093/pm/pny031.

    PMID: 29741660BACKGROUND

  • Chinn E, Friedman BW, Naeem F, Irizarry E, Afrifa F, Zias E, Jones MP, Pearlman S, Chertoff A, Wollowitz A, Gallagher EJ. Randomized Trial of Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain in the Emergency Department. Ann Emerg Med. 2019 Aug;74(2):233-240. doi: 10.1016/j.annemergmed.2019.01.021. Epub 2019 Feb 26.

    PMID: 30819520BACKGROUND

Related Links

MeSH Terms

Conditions

Abdominal PainRenal Colic

Interventions

LidocaineHydromorphone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Limitations and Caveats

No statistical analysis was done due to enrolling only 4 subjects before the trial was terminated.

Results Point of Contact

Title
Elliott Chinn, DO
Organization
Hennepin County Medical Center, Department of Emergency Medicine
elliott.chinn@hcmed.org
612-873-3508

Study Officials

  • Elliott Chinn, DO

    Hennepin County Medical Center, Minneapolis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 21, 2020

Study Start

February 18, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

January 17, 2024

Results First Posted

January 17, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)