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Completed

NCT Number: NCT03391427

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Center

London, Ontario, N6A 5A5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

This group will receive lidocaine infusion

Other names: Xylocaine, Lidocaine infusion

ketamine

Drug

This group will receive Ketamine infusion

Other names: Ketamine infusion

Lidocaine+ketamine

Drug

This group will receive mixture of ketamine and lidocaine infusion

Other names: Lidocaine infusion, Ketamine infusion, Xylocaine

Saline

Drug

This group will receive saline infusion

Other names: Normal saline

Primary outcomes

  1. Opioid consumption

    Time frame: 24 hr

    Total milligrams of opioids consumed would be measured

Secondary outcomes

  1. Opioid consumption

    Time frame: 48 hrs

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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. Opioid consumption

    Time frame: 72 hrs

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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
Jan 5, 2018
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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