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

NCT ID: NCT02450214

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-07-31

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control group (C)

50 mL syringe with saline, plus 1 flask of 100 mL saline (Saline)

Group Type: SHAM_COMPARATOR

Saline

Intervention Type: DRUG

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

Ketamine group (K)

50 mL syringe with ketamine (50mg / 50ml), plus 1 flask of 100 mL saline (Ketamine)

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

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)

Group Type: EXPERIMENTAL

Ketamine + magnesium

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Veronica Varas Vega

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clinico de la Universidad de Chile

Santiago, RM, Chile

Countries

Chile

Other Identifiers

OAIC N 722/15

Identifier Type: -

Identifier Source: org_study_id