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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02450214
Acronym
KEMPLA
Enrollment
63
Registered
2015-05-21
Start date
2015-06-30
Completion date
2017-07-31
Last updated
2018-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Ketamine, Magnesium, Analgesia, Liposuction, Lipoabdominoplasty, Preemptive analgesia

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.

Interventions

DRUGSaline

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

DRUGKetamine

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

DRUGKetamine + 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

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Opioids consumption12 h after surgery
Postoperative Pain (Postoperative Pain and Disability Scale)2, 7, 14, 21, 45 and 90 days after surgeryPostoperative Pain and Disability Scale (Body-PPDS) will be used to quantify pain

Secondary

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

Other

MeasureTime frameDescription
Drug Side EffectFirst day after surgeryHallucinations, unpleasent dreams or some patient discomfort, sedation level, pruritus, hypotension, bradycardia, urinary retention, nausea, vomiting.
Other VariablesFirst daySociodemographic 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.

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026