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

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ClinicalTrials.gov Identifier: NCT03391427
Recruitment Status : Completed
First Posted : January 5, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE December 10, 2017
First Posted Date  ICMJE January 5, 2018
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE March 1, 2011
Actual Primary Completion Date November 4, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2017)
Opioid consumption [ Time Frame: 24 hr ]
Total milligrams of opioids consumed would be measured
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2017)
  • Opioid consumption [ Time Frame: 48 hrs ]
    Total milligrams of opioids consumed would be measured. Higher opioid consumption indicates worse pain control.
  • Opioid related side effects [ Time Frame: 72 hrs ]
    Questions regarding all opioid related side effects will be asked. These will include inquiry regarding nausea, vomiting, hallucinations, sedation, respiratory depression, pruritus
  • Chronic pain [ Time Frame: 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.
  • Patient satisfaction [ Time Frame: 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.
  • Chronic pain [ Time Frame: 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.
  • Opioid consumption [ Time Frame: 72 hrs ]
    Total milligrams of opioids consumed would be measured. Higher opioid consumption indicates worse pain control.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine, Lidocaine and Combination for Postoperative Analgesia in Open Liver Resection
Official Title  ICMJE Ketamine, Lidocaine and Combination for Postoperative Analgesia in Open Liver Resection: A Prospective, Randomized, Four-arm, Double Blind, Placebo Controlled Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Lidocaine, 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
Condition  ICMJE Hepatectomy
Intervention  ICMJE
  • Drug: Lidocaine
    This group will receive lidocaine infusion
    Other Names:
    • Xylocaine
    • Lidocaine infusion
  • Drug: Ketamine
    This group will receive Ketamine infusion
    Other Name: Ketamine infusion
  • Drug: Lidocaine+ketamine
    This group will receive mixture of ketamine and lidocaine infusion
    Other Names:
    • Lidocaine infusion
    • Ketamine infusion
    • Xylocaine
  • Drug: Saline
    This group will receive saline infusion
    Other Name: Normal saline
Study Arms  ICMJE
  • Experimental: Lidocaine
    This group will receive lidocaine infusion perioperatively
    Intervention: Drug: Lidocaine
  • Experimental: Ketamine
    This group will receive ketamine infusion perioperatively
    Intervention: Drug: Ketamine
  • Experimental: Lidocaine+ketamine
    This group will receive a combination of lidocaine and ketamine infusion, perioperatively
    Intervention: Drug: Lidocaine+ketamine
  • Placebo Comparator: placebo
    This group will receive saline infusion as placebo perioperatively
    Intervention: Drug: Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 29, 2017)
124
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2017
Actual Primary Completion Date November 4, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03391427
Other Study ID Numbers  ICMJE 17003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Achal Dhir Lawson
PRS Account Lawson Health Research Institute
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP