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

Pain, Postoperative Clinical Trial

— KEMPLA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02450214
• Other study ID #: OAIC N 722/15
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: July 2017

Study information

• Verified date: October 2016
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Chile	Hospital Clinico de la Universidad de Chile	Santiago	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drug Side Effect	Hallucinations, unpleasent dreams or some patient discomfort, sedation level, pruritus, hypotension, bradycardia, urinary retention, nausea, vomiting.	First day after surgery
Other	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
Primary	Opioids consumption		12 h after surgery
Primary	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	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
Secondary	Early postoperative pain (Time to first request for supplemental analgesia)	Time to first request for supplemental analgesia.	1 day
Secondary	Disability (Time delay in returning to work)	Time delay in returning to work.	90 days
Secondary	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