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

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ClinicalTrials.gov Identifier: NCT02450214
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Veronica Varas Vega, University of Chile

Tracking Information
First Submitted Date  ICMJE May 18, 2015
First Posted Date  ICMJE May 21, 2015
Last Update Posted Date May 2, 2018
Study Start Date  ICMJE June 2015
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2015)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2015)
Postoperative Pain (Postoperative Pain and Disability Scale) [ Time Frame: 90 days after surgery ]
Postoperative Pain and Disability Scale (Body-PPDS) will be used to quantify pain
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2015)
  • Early postoperative pain (Visual analogue pain scale) [ Time Frame: 1 day ]
    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.
  • Opioid consumption [ Time Frame: 1 day ]
    Opioid consumption
  • Postoperative Pain (McGill scale) [ Time Frame: 90 days after surgery ]
    McGill scale for chronic painwill be used to quantify pain
Current Other Pre-specified Outcome Measures
 (submitted: December 19, 2015)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraoperative Ketamine and Magnesium Therapy for Control of Postoperative Pain After a Liposuction and Lipoabdominoplasty
Official Title  ICMJE Efficacy of Ketamine and Magnesium Association in the Postoperative Pain After Liposuction and Lipoabdominoplasty: Prospective, Randomized and Blinded Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Sham Comparator: Control group (C)
    50 mL syringe with saline, plus 1 flask of 100 mL saline (Saline)
    Intervention: Drug: Saline
  • Experimental: Ketamine group (K)
    50 mL syringe with ketamine (50mg / 50ml), plus 1 flask of 100 mL saline (Ketamine)
    Intervention: Drug: 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)
    Intervention: Drug: Ketamine + magnesium
Publications * Not Provided

*   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: May 1, 2018)
63
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2015)
60
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02450214
Other Study ID Numbers  ICMJE OAIC N 722/15
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Veronica Varas Vega, University of Chile
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Chile
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Chile
Verification Date October 2016

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