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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Saline; Drug: Ketamine; Drug: Ketamine + magnesium

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • RM
    • Santiago, RM, Chile, 7690306
      • Hospital Clinico de la Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Control group (C); 50 mL syringe with saline, plus 1 flask of 100 mL saline (Saline)	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
EXPERIMENTAL: Ketamine group (K); 50 mL syringe with ketamine (50mg / 50ml), plus 1 flask of 100 mL saline (Ketamine)	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
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)	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Side Effect	Hallucinations, unpleasent dreams or some patient discomfort, sedation level, pruritus, hypotension, bradycardia, urinary retention, nausea, vomiting.	First day after surgery
Other Variables	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.	First day

Collaborators and Investigators

• Sponsor: University of Chile

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: May 18, 2015
• First Submitted That Met QC Criteria: May 20, 2015
• First Posted (ESTIMATE): May 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Analgesia; Ketamine; Magnesium; Preemptive analgesia; Liposuction; Lipoabdominoplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: OAIC N 722/15