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

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Ketamine; Drug: Ketamine + magnesium; Drug: Saline

• Registration Number: NCT02450214
• Lead Sponsor: University of Chile

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-21
• Study Start: 2015-06
• Status Verified: 2016-10
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine group (K)	Ketamine	50 mL syringe with ketamine (50mg / 50ml), plus 1 flask of 100 mL saline (Ketamine)
Magnesium + ketamine group (MGK)	Ketamine + magnesium	50mL syringe with ketamine (50mg / 50ml), plus a flask of 100ml of saline with 5 g of magnesium sulfate (Ketamine + magnesium)
Control group (C)	Saline	50 mL syringe with saline, plus 1 flask of 100 mL saline (Saline)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clinico de la Universidad de Chile; 🇨🇱 Santiago, RM, Chile