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

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03391427
Collaborator
(none)
124
1
4
82
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Lidocaine, ketamine, combination and placebo are being evaluated for treating postoperative pain in major liver resectionLidocaine, ketamine, combination and placebo are being evaluated for treating postoperative pain in major liver resection
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
All persons are blinded as the drug is formulated by the investigator who is not the care giver or outcomes assessor
Primary Purpose:
Treatment
Official Title:
Ketamine, Lidocaine and Combination for Postoperative Analgesia in Open Liver Resection: A Prospective, Randomized, Four-arm, Double Blind, Placebo Controlled Trial
Actual Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Nov 4, 2015
Actual Study Completion Date :
Dec 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lidocaine

This group will receive lidocaine infusion perioperatively

Drug: Lidocaine
This group will receive lidocaine infusion
Other Names:
  • Xylocaine
  • Lidocaine infusion
  • Experimental: Ketamine

    This group will receive ketamine infusion perioperatively

    Drug: Ketamine
    This group will receive Ketamine infusion
    Other Names:
  • Ketamine infusion
  • Experimental: Lidocaine+ketamine

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

    Drug: Lidocaine+ketamine
    This group will receive mixture of ketamine and lidocaine infusion
    Other Names:
  • Lidocaine infusion
  • Ketamine infusion
  • Xylocaine
  • Placebo Comparator: placebo

    This group will receive saline infusion as placebo perioperatively

    Drug: Saline
    This group will receive saline infusion
    Other Names:
  • Normal saline
  • Outcome Measures

    Primary Outcome Measures

    1. Opioid consumption [24 hr]

      Total milligrams of opioids consumed would be measured

    Secondary Outcome Measures

    1. Opioid consumption [48 hrs]

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

    2. Opioid related side effects [72 hrs]

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

    3. Chronic pain [6 weeks]

      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.

    4. Patient satisfaction [72 hrs]

      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.

    5. Chronic pain [12 weeks]

      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.

    6. Opioid consumption [72 hrs]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ASA physical status 2-4

    • Elective major liver resection

    • Signed informed consent

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 London Health Sciences Center London Ontario Canada N6A 5A5

    Sponsors and Collaborators

    • Lawson Health Research Institute

    Investigators

    • Principal Investigator: Achal Dhir, Lawson

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Lawson Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT03391427
    Other Study ID Numbers:
    • 17003
    First Posted:
    Jan 5, 2018
    Last Update Posted:
    May 29, 2019
    Last Verified:
    May 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lawson Health Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 29, 2019