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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Saline
* Drug: Ketamine
* Drug: Ketamine + magnesium


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control group (C)<br>50 mL syringe with saline, plus 1 flask of 100 mL saline (Saline) | Drug: Saline<br>* 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<br>|
| Experimental: Ketamine group (K)<br>50 mL syringe with ketamine (50mg / 50ml), plus 1 flask of 100 mL saline (Ketamine) | Drug: Ketamine<br>* 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<br>|
| Experimental: Magnesium + ketamine group (MGK)<br>50mL syringe with ketamine (50mg / 50ml), plus a flask of 100ml of saline with 5 g of magnesium sulfate (Ketamine + magnesium) | Drug: Ketamine + magnesium<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Magnesium, Analgesia, Liposuction, Lipoabdominoplasty, Preemptive analgesia