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CompletedNCT03391427Updated Jul 6, 2023

Ketamine, Lidocaine and Combination for Postoperative Analgesia in Open Liver Resection

An interventional study of Lidocaine and Ketamine in Hepatectomy, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-06.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 9 months after the study started (first participant enrolled Mar 2011, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

All study participants were monitored according to American Society of Anesthesiologists guidelines. All received intrathecal morphine (300 to 400 mcg) at L3-4 interspace via 25 G Whitacre needle. Participants were then randomized (computer generated) into one of four groups.

General anesthesia was induced and endotracheal intubation was done. Immediately, after intubation, Lidocaine group (L) received a Lidocaine infusion at 0.33 mg/kg/h.

The Ketamine group (K) received a ketamine infusion at 70 mcg/Kg/h. The Lidocaine-Ketamine group (LK) received a Lidocaine infusion at 0.33 mg/kg/h plus a Ketamine infusion at 70 mcg/Kg/h.

The control group (P) received a normal saline infusion to keep the blind. The infusions were stopped approximately 30-45 minute before the completion of surgery.

All participants received a hydromorphone patient-controlled analgesia (PCA) via a pump. All were given acetaminophen 650 mg every 6 hrs for 4 days.

Postoperatively, participants were monitored for nausea, vomiting, sedation, respiratory depression, light-headedness, perioral numbness, pruritus, disturbed dreams and hallucinations.

Postoperative Hydromorphone consumption for the first, second and third day was recorded from the chart maintained by acute pain service team who were blinded to the group assignment.

After the operation, study participants were interviewed at regular intervals by a blinded investigator about their current pain level, as well as satisfaction with pain management. They were also be questioned regarding the presence and severity of opioid-related side effects (nausea, vomiting, sedation, respiratory depression and, pruritus) and light-headedness, perioral numbness, disturbed dreams and hallucinations. Hospital charts were reviewed and data collected to analyze time to request for additional analgesia and total consumption of opioids, non-opioid analgesics, anti-emetics, and antipruritics within the first 72 hours postoperatively.

02

Conditions studied

  • Hepatectomy

Keywords

  • Lidocaine
  • Ketamine
  • postoperative analgesia
03

In context

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 331 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 2-4
  • Elective major liver resection
  • Signed

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
124 participants (actual)

Study arms

  • Experimental
    Lidocaine

    This group will receive lidocaine infusion perioperatively

    Drug: Lidocaine

  • Experimental
    Ketamine

    This group will receive ketamine infusion perioperatively

    Drug: Ketamine

  • Experimental
    Lidocaine+ketamine

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

    Drug: Lidocaine+ketamine

  • Placebo comparator
    placebo

    This group will receive saline infusion as placebo perioperatively

    Drug: Saline

Interventions

  • This group will receive lidocaine infusion

    Also known as: Xylocaine, Lidocaine infusion

  • This group will receive Ketamine infusion

    Also known as: Ketamine infusion

  • DrugLidocaine+ketamine

    Drug pages: Lidocaine · Ketamine

    This group will receive mixture of ketamine and lidocaine infusion

    Also known as: Lidocaine infusion, Ketamine infusion, Xylocaine

  • DrugSaline

    This group will receive saline infusion

    Also known as: Normal saline

06

What researchers measure

Primary outcomes

  1. Opioid consumption

    Total milligrams of opioids consumed would be measured

    Time frame: 24 hr

Secondary outcomes

  1. Opioid consumption

    Total milligrams of opioids consumed would be measured. Higher opioid consumption indicates worse pain control.

    Time frame: 48 hrs

  2. Opioid related side effects

    Questions regarding all opioid related side effects will be asked. These will include inquiry regarding nausea, vomiting, hallucinations, sedation, respiratory depression, pruritus

    Time frame: 72 hrs

  3. Chronic pain

    Incidence of chronic pain at 6 weeks will be noted by a numerical rating scale of 1-10 where 0 would be no pain at all and 10 would be worst possible pain. This is standard pain assessment tool. Lower numbers indication better outcomes.

    Time frame: 6 weeks

  4. Patient satisfaction

    Patient satisfaction will be noted using a numeric rating scale; where 0 will be completely unsatisfied and 10 will be completely satisfied. Higher values depict better satisfaction and better outcomes.

    Time frame: 72 hrs

  5. Chronic pain

    Incidence of chronic pain at 12 weeks will be noted by a numerical rating scale of 1-10 where 0 would be no pain at all and 10 would be worst possible pain. This is standard pain assessment tool. Lower numbers indication better outcomes.

    Time frame: 12 weeks

  6. Opioid consumption

    Total milligrams of opioids consumed would be measured. Higher opioid consumption indicates worse pain control.

    Time frame: 72 hrs

07

Study locations

1 site
  • London Health Sciences Center
    London, Ontario N6A 5A5, Canada
08

References and documents

Publications

  • 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. PubMed 19285304 ↗
  • 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. PubMed 19647665 ↗
  • 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. PubMed 19326422 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03391427
Responsible party
Shalini Dhir (Associate Professor, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
Jan 5, 2018
Start date
Mar 1, 2011
Primary completion
Nov 4, 2015
Completion
Dec 30, 2017
Last update
Jul 6, 2023

Study contacts

Achal Dhir
principal investigator · Lawson

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Lidocaine · Ketamine

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