Intraoperative Ketamine and Magnesium Therapy for Control of Postoperative Pain After a Liposuction and Lipoabdominoplasty

Ketamine

Brief Summary

Lipoabdominoplasty and liposuction are one of the most common plastic surgeries. The management of postoperative pain is complex. Non Steroidal Anti Inflammatory Drugs (NSAIDs) are insufficient, while opioids are avoided by their adverse effects and regional techniques are hampered by a premature discharge. In this context, the investigators seek an intraoperative multimodal analgesic technique blocking NMDA receptors with ketamine plus magnesium to significantly decrease postoperative pain.

Intervention / Treatment

  • Saline (DRUG)
    50 mL syringe will be infused at 0.3 mL/Kg in bolus and then 0.15 mL/Kg/h 100 mL flask will be infused at 1mL/Kg in bolus for 30 min and then 0.25mL/Kg/h
  • Ketamine (DRUG)
    50 mL syringe will be infused at 0.3 mL/Kg in bolus and then 0.15 mL/Kg/h 100 mL flask will be infused at 1mL/Kg in bolus for 30 min and then 0.25mL/Kg/h
  • Ketamine + magnesium (DRUG)
    50 mL syringe will be infused at 0.3 mL/Kg in bolus and then 0.15 mL/Kg/h 100 mL flask will be infused at 1mL/Kg in bolus for 30 min and then 0.25mL/Kg/h

Condition or Disease

  • Pain, Postoperative

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 63 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Jun 01, 2015
    Primary Completion: Jul 01, 2017 ACTUAL
    Completion Date: Jul 01, 2017 ACTUAL
    Study First Posted: May 21, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: May 01, 2018

    Sponsors / Collaborators

    Lead Sponsor: University of Chile
    Responsible Party: N/A

    Location

    Santiago, Chile

    Participant Groups

    • 50 mL syringe with saline, plus 1 flask of 100 mL saline (Saline)

    • 50 mL syringe with ketamine (50mg / 50ml), plus 1 flask of 100 mL saline (Ketamine)

    • 50mL syringe with ketamine (50mg / 50ml), plus a flask of 100ml of saline with 5 g of magnesium sulfate (Ketamine + magnesium)

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Female and male
    * 18 years or older
    * Liposuction and lipoabdominoplasty
    * ASA 1 and 2
    * BMI 21-28 Kg/m2
    * Full secondary education

    Exclusion Criteria:

    * Patients with surgeries added to the main proceedings
    * Scheduled to tuck in Flor de Lis or Body Lift
    * History of use of analgesic drugs 48 hours before surgery
    * Peripheral central neurological diseases
    * Known allergy will be excluded to medication in use in this study (ketamine, magnesium, clindamycin and penicillin or other)

    Primary Outcomes
    • Opioids consumption 12 h after surgery

    • Postoperative Pain and Disability Scale (Body-PPDS) will be used to quantify pain

    Secondary Outcomes

    • Visual analogue pain scale (0-10) will be used to quantify pain

    • Time to first request for supplemental analgesia.

    • Time delay in returning to work.

    • McGill scale for chronic painwill be used to quantify pain

    Other Outcomes

    • Hallucinations, unpleasent dreams or some patient discomfort, sedation level, pruritus, hypotension, bradycardia, urinary retention, nausea, vomiting.

    • Sociodemographic variables; surgical variables as liters of aspirated fat, weight of resected flap, operative time, bleeding measured as the difference between pre and postoperative hemoblobinemia, immediate postoperative complications such as bleeding or hematoma and thromboembolic complications; anesthetic variables as total amount of remifentanil and sevorane consumption.

    More Details

    NCT Number: NCT02450214
    Acronym: KEMPLA
    Other IDs: OAIC N 722/15
    Study URL: https://clinicaltrials.gov/study/NCT02450214
    Last updated: Sep 29, 2023