NCT03391427

Brief Summary

Lidocaine and ketamine both are being used for perioperative analgesia. Perioperative lidocaine infusion has been shown to reduce postoperative pain and opioid consumption. Perioperative low dose Ketamine has shown improved postoperative pain and reduced opioid usage. We therefore tested the hypothesis that the combination would provide better analgesia in the milieu of intrathecal morphine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2017

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

4.7 years

First QC Date

December 10, 2017

Last Update Submit

July 4, 2023

Conditions

Hepatectomy

Keywords

LidocaineKetaminepostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    Total milligrams of opioids consumed would be measured

    24 hr

Secondary Outcomes (6)

  • Opioid consumption

    48 hrs

  • Opioid related side effects

    72 hrs

  • Chronic pain

    6 weeks

  • Patient satisfaction

    72 hrs

  • Chronic pain

    12 weeks

  • +1 more secondary outcomes

Study Arms (4)

Lidocaine

EXPERIMENTAL

This group will receive lidocaine infusion perioperatively

Drug: Lidocaine

Ketamine

EXPERIMENTAL

This group will receive ketamine infusion perioperatively

Drug: Ketamine

Lidocaine+ketamine

EXPERIMENTAL

This group will receive a combination of lidocaine and ketamine infusion, perioperatively

Drug: Lidocaine+ketamine

placebo

PLACEBO COMPARATOR

This group will receive saline infusion as placebo perioperatively

Drug: Saline

Interventions

LidocaineDRUG

This group will receive lidocaine infusion

Also known as: Xylocaine, Lidocaine infusion
Lidocaine
KetamineDRUG

This group will receive Ketamine infusion

Also known as: Ketamine infusion
Ketamine
Lidocaine+ketamineDRUG

This group will receive mixture of ketamine and lidocaine infusion

Also known as: Lidocaine infusion, Ketamine infusion, Xylocaine
Lidocaine+ketamine
SalineDRUG

This group will receive saline infusion

Also known as: Normal saline
placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status 2-4
  • Elective major liver resection
  • Signed informed consent

You may not qualify if:

  • ICU admission after surgery
  • tracheal extubation not planned after surgery
  • language barrier
  • mental impairment
  • severe coagulopathy
  • chronic pain or opioid dependance or both
  • alcohol/substance abuse
  • allergy to the study drugs
  • refusal for spinal
  • infection at site of spinal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Center

London, Ontario, N6A 5A5, Canada

Location

Related Publications (3)

  • Harvey KP, Adair JD, Isho M, Robinson R. Can intravenous lidocaine decrease postsurgical ileus and shorten hospital stay in elective bowel surgery? A pilot study and literature review. Am J Surg. 2009 Aug;198(2):231-6. doi: 10.1016/j.amjsurg.2008.10.015. Epub 2009 Mar 12.

    PMID: 19285304BACKGROUND

  • Rakic AM, Golembiewski J. Low-dose ketamine infusion for postoperative pain management. J Perianesth Nurs. 2009 Aug;24(4):254-7. doi: 10.1016/j.jopan.2009.05.097. No abstract available.

    PMID: 19647665BACKGROUND

  • Ko JS, Choi SJ, Gwak MS, Kim GS, Ahn HJ, Kim JA, Hahm TS, Cho HS, Kim KM, Joh JW. Intrathecal morphine combined with intravenous patient-controlled analgesia is an effective and safe method for immediate postoperative pain control in live liver donors. Liver Transpl. 2009 Apr;15(4):381-9. doi: 10.1002/lt.21625.

    PMID: 19326422BACKGROUND

MeSH Terms

Interventions

LidocaineKetamineSodium ChlorideSaline Solution

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Achal Dhir

    Lawson

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
All persons are blinded as the drug is formulated by the investigator who is not the care giver or outcomes assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Lidocaine, ketamine, combination and placebo are being evaluated for treating postoperative pain in major liver resection
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 10, 2017

First Posted

January 5, 2018

Study Start

March 1, 2011

Primary Completion

November 4, 2015

Study Completion

December 30, 2017

Last Updated

July 6, 2023

Record last verified: 2023-07

Locations

CA(1)