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HepatectomyNCT03391427

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

A study testing Lidocaine, Ketamine and Lidocaine+ketamine in people with Hepatectomy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hepatectomy
What is being tested?
Lidocaine, Ketamine and Lidocaine+ketamine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
1 siteCanada
Study dates
1 Mar 2011to 30 Dec 2017
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • ICU admission after surgery
  • tracheal extubation not planned after surgery
  • language barrier
  • mental impairment
  • severe coagulopathy
  • chronic pain or opioid dependance or both
Show all 10Show fewer
  • alcohol/substance abuse
  • allergy to the study drugs
  • refusal for spinal
  • infection at site of spinal

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • London Health Sciences Center

    London, Ontario, N6A 5A5

Other trials in Canada

About this study

Official title: Ketamine, Lidocaine and Combination for Postoperative Analgesia in Open Liver Resection: A Prospective, Randomized, Four-arm, Double Blind, Placebo Controlled Trial

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.

Conditions
Hepatectomy
Being tested
Lidocaine, Ketamine, Lidocaine+ketamine, Saline
Keywords
Lidocaine, Ketamine, postoperative analgesia

What participants receive

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

  • LidocaineDrug

    Also called Xylocaine, Lidocaine infusion

    This group will receive lidocaine infusion

  • KetamineDrug

    Also called Ketamine infusion

    This group will receive Ketamine infusion

  • Lidocaine+ketamineDrug

    Also called Lidocaine infusion, Ketamine infusion, Xylocaine

    This group will receive mixture of ketamine and lidocaine infusion

  • SalineDrug

    Also called Normal saline

    This group will receive saline infusion

Study groups in NCT03391427
Study groupRoleWhat they receive
LidocaineExperimentalThis group will receive lidocaine infusion perioperatively
Receives: Drug: Lidocaine
KetamineExperimentalThis group will receive ketamine infusion perioperatively
Receives: Drug: Ketamine
Lidocaine+ketamineExperimentalThis group will receive a combination of lidocaine and ketamine infusion, perioperatively
Receives: Drug: Lidocaine+ketamine
placeboPlacebo comparatorThis group will receive saline infusion as placebo perioperatively
Receives: Drug: Saline

What is being measured

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

  1. Opioid consumption

    Total milligrams of opioids consumed would be measured

    Measured: 24 hr

Secondary outcomes (6)

  1. Opioid consumption

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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 12 weeks

  6. Opioid consumption

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

    Measured: 72 hrs

Timeline

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

  1. First posted5 Jan 2018
  2. Study start1 Mar 2011
  3. Primary completion4 Nov 2015
  4. Study completion30 Dec 2017

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
Model description
Lidocaine, ketamine, combination and placebo are being evaluated for treating postoperative pain in major liver resection
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03391427
Sponsor's protocol ID
17003
Status last verified
Jul 2023
First submitted
10 Dec 2017
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine, Ketamine and Lidocaine+ketamine in people with Hepatectomy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

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 3 inclusion and 10 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: finished, as of the sponsor's last update on 6 Jul 2023. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid consumption (time frame: 24 hr). 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 NCT03391427, which also lists 3 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 6 Jul 2023.

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