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

Overview

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.

Full Title of Study: “Efficacy of Ketamine and Magnesium Association in the Postoperative Pain After Liposuction and Lipoabdominoplasty: Prospective, Randomized and Blinded Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2017

Interventions

  • Drug: Saline
    • 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
  • Drug: Ketamine
    • 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
  • Drug: Ketamine + magnesium
    • 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

Arms, Groups and Cohorts

  • Sham Comparator: Control group (C)
    • 50 mL syringe with saline, plus 1 flask of 100 mL saline (Saline)
  • Experimental: Ketamine group (K)
    • 50 mL syringe with ketamine (50mg / 50ml), plus 1 flask of 100 mL saline (Ketamine)
  • Experimental: Magnesium + ketamine group (MGK)
    • 50mL syringe with ketamine (50mg / 50ml), plus a flask of 100ml of saline with 5 g of magnesium sulfate (Ketamine + magnesium)

Clinical Trial Outcome Measures

Primary Measures

  • Opioids consumption
    • Time Frame: 12 h after surgery
  • Postoperative Pain (Postoperative Pain and Disability Scale)
    • Time Frame: 2, 7, 14, 21, 45 and 90 days after surgery
    • Postoperative Pain and Disability Scale (Body-PPDS) will be used to quantify pain

Secondary Measures

  • Early postoperative pain (Visual analogue pain scale)
    • Time Frame: 0, 2, 4, 6, 12 and 24 h after surgery
    • Visual analogue pain scale (0-10) will be used to quantify pain
  • Early postoperative pain (Time to first request for supplemental analgesia)
    • Time Frame: 1 day
    • Time to first request for supplemental analgesia.
  • Disability (Time delay in returning to work)
    • Time Frame: 90 days
    • Time delay in returning to work.
  • Postoperative Chronic Pain (McGill scale)
    • Time Frame: Day after surgery, 7, 30 and 90 days after surgery
    • McGill scale for chronic painwill be used to quantify pain

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Chile
  • Provider of Information About this Clinical Study
    • Principal Investigator: Veronica Varas Vega, MD – University of Chile

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