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Completed

NCT Number: NCT02450214

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

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.

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Key information

Conditions

Pain, Postoperative Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinico de la Universidad de Chile

Santiago, RM, 7690306, Chile

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

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

Primary outcomes

  1. Opioids consumption

    Time frame: 12 h after surgery

  2. 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 outcomes

  1. 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

  2. Early postoperative pain (Time to first request for supplemental analgesia)

    Time frame: 1 day

    Time to first request for supplemental analgesia.

  3. Disability (Time delay in returning to work)

    Time frame: 90 days

    Time delay in returning to work.

  4. 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

Other outcomes

  1. Drug Side Effect

    Time frame: First day after surgery

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

  2. Other Variables

    Time frame: First day

    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.

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

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

Acronym: KEMPLA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 21, 2015
Registry last updated
May 2, 2018

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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