Back to resultsIntraoperative Ketamine and Magnesium Therapy for Control of Postoperative Pain After a Liposuction and Lipoabdominoplasty (KEMPLA)
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Saline
Ketamine
Ketamine + magnesium
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative focused on measuring Ketamine, Magnesium, Analgesia, Liposuction, Lipoabdominoplasty, Preemptive analgesia
Eligibility Criteria
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)
Sites / Locations
- Hospital Clinico de la Universidad de Chile
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Experimental
Arm Label
Control group (C)
Ketamine group (K)
Magnesium + ketamine group (MGK)
Arm Description
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)
Outcomes
Primary Outcome Measures
Opioids consumption
Postoperative Pain (Postoperative Pain and Disability Scale)
Postoperative Pain and Disability Scale (Body-PPDS) will be used to quantify pain
Secondary Outcome Measures
Early postoperative pain (Visual analogue pain scale)
Visual analogue pain scale (0-10) will be used to quantify pain
Early postoperative pain (Time to first request for supplemental analgesia)
Time to first request for supplemental analgesia.
Disability (Time delay in returning to work)
Time delay in returning to work.
Postoperative Chronic Pain (McGill scale)
McGill scale for chronic painwill be used to quantify pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02450214
Brief Title
Intraoperative Ketamine and Magnesium Therapy for Control of Postoperative Pain After a Liposuction and Lipoabdominoplasty
Acronym
KEMPLA
Official Title
Efficacy of Ketamine and Magnesium Association in the Postoperative Pain After Liposuction and Lipoabdominoplasty: Prospective, Randomized and Blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Ketamine, Magnesium, Analgesia, Liposuction, Lipoabdominoplasty, Preemptive analgesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group (C)
Arm Type
Sham Comparator
Arm Description
50 mL syringe with saline, plus 1 flask of 100 mL saline (Saline)
Arm Title
Ketamine group (K)
Arm Type
Experimental
Arm Description
50 mL syringe with ketamine (50mg / 50ml), plus 1 flask of 100 mL saline (Ketamine)
Arm Title
Magnesium + ketamine group (MGK)
Arm Type
Experimental
Arm Description
50mL syringe with ketamine (50mg / 50ml), plus a flask of 100ml of saline with 5 g of magnesium sulfate (Ketamine + magnesium)
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ketamine + magnesium
Intervention Description
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 Outcome Measure Information:
Title
Opioids consumption
Time Frame
12 h after surgery
Title
Postoperative Pain (Postoperative Pain and Disability Scale)
Description
Postoperative Pain and Disability Scale (Body-PPDS) will be used to quantify pain
Time Frame
2, 7, 14, 21, 45 and 90 days after surgery
Secondary Outcome Measure Information:
Title
Early postoperative pain (Visual analogue pain scale)
Description
Visual analogue pain scale (0-10) will be used to quantify pain
Time Frame
0, 2, 4, 6, 12 and 24 h after surgery
Title
Early postoperative pain (Time to first request for supplemental analgesia)
Description
Time to first request for supplemental analgesia.
Time Frame
1 day
Title
Disability (Time delay in returning to work)
Description
Time delay in returning to work.
Time Frame
90 days
Title
Postoperative Chronic Pain (McGill scale)
Description
McGill scale for chronic painwill be used to quantify pain
Time Frame
Day after surgery, 7, 30 and 90 days after surgery
Other Pre-specified Outcome Measures:
Title
Drug Side Effect
Description
Hallucinations, unpleasent dreams or some patient discomfort, sedation level, pruritus, hypotension, bradycardia, urinary retention, nausea, vomiting.
Time Frame
First day after surgery
Title
Other Variables
Description
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.
Time Frame
First day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Hospital Clinico de la Universidad de Chile
City
Santiago
State/Province
RM
ZIP/Postal Code
7690306
Country
Chile
12. IPD Sharing Statement
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Intraoperative Ketamine and Magnesium Therapy for Control of Postoperative Pain After a Liposuction and Lipoabdominoplasty
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