Pain, PostoperativeKEMPLANCT02450214
Intraoperative Ketamine and Magnesium Therapy for Control of Postoperative Pain After a Liposuction and Lipoabdominoplasty
A study testing Saline, Ketamine and Ketamine + magnesium in people with Pain, Postoperative, run by University of Chile at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Saline, Ketamine and Ketamine + magnesium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteChile
- Study dates
- Jun 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male
- 18 years or older
- Liposuction and lipoabdominoplasty
- ASA 1 and 2
- BMI 21-28 Kg/m2
- Full secondary education
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pain, Postoperative
- Being tested
- Saline, Ketamine, Ketamine + magnesium
- Keywords
- Ketamine, Magnesium, Analgesia, Liposuction, Lipoabdominoplasty, Preemptive analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
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
KetamineDrug
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 + magnesiumDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Control group (C) | Sham comparator | 50 mL syringe with saline, plus 1 flask of 100 mL saline (Saline) Receives: Drug: Saline |
| Ketamine group (K) | Experimental | 50 mL syringe with ketamine (50mg / 50ml), plus 1 flask of 100 mL saline (Ketamine) Receives: Drug: Ketamine |
| Magnesium + ketamine group (MGK) | Experimental | 50mL syringe with ketamine (50mg / 50ml), plus a flask of 100ml of saline with 5 g of magnesium sulfate (Ketamine + magnesium) Receives: Drug: Ketamine + magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioids consumption
Measured: 12 h after surgery
Postoperative Pain (Postoperative Pain and Disability Scale)
Postoperative Pain and Disability Scale (Body-PPDS) will be used to quantify pain
Measured: 2, 7, 14, 21, 45 and 90 days after surgery
Secondary outcomes (4)
Early postoperative pain (Visual analogue pain scale)
Visual analogue pain scale (0-10) will be used to quantify pain
Measured: 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.
Measured: 1 day
Disability (Time delay in returning to work)
Time delay in returning to work.
Measured: 90 days
Postoperative Chronic Pain (McGill scale)
McGill scale for chronic painwill be used to quantify pain
Measured: Day after surgery, 7, 30 and 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronica Varas Vega, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450214
- Sponsor's protocol ID
- OAIC N 722/15
- Acronym
- KEMPLA
- Status last verified
- Oct 2016
- First submitted
- 18 May 2015
- Last updated
- 2 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ketamine and Magnesium Association in the Postoperative Pain After Liposuction and Lipoabdominoplasty: Prospective, Randomized and Blinded Study
- ClinicalTrials.gov ID
- NCT02450214
- Acronym / sponsor ID
- KEMPLA / OAIC N 722/15
- Conditions
- Pain, Postoperative
- Keywords
- Ketamine, Magnesium, Analgesia, Liposuction, Lipoabdominoplasty, Preemptive analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group (C) | Sham comparator | Drug: Saline50 mL syringe with saline, plus 1 flask of 100 mL saline (Saline) |
| Ketamine group (K) | Experimental | Drug: Ketamine50 mL syringe with ketamine (50mg / 50ml), plus 1 flask of 100 mL saline (Ketamine) |
| Magnesium + ketamine group (MGK) | Experimental | Drug: Ketamine + magnesium50mL syringe with ketamine (50mg / 50ml), plus a flask of 100ml of saline with 5 g of magnesium sulfate (Ketamine + magnesium) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female and male
- 18 years or older
- Liposuction and lipoabdominoplasty
- ASA 1 and 2
- BMI 21-28 Kg/m2
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline50 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 | Drug | Control group (C) |
| Ketamine50 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 | Drug | Ketamine group (K) |
| Ketamine + magnesium50 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 | Drug | Magnesium + ketamine group (MGK) |
Primary outcome
Opioids consumption
Time frame: 12 h after surgery
Postoperative Pain (Postoperative Pain and Disability Scale)
Time frame: 2, 7, 14, 21, 45 and 90 days after surgery
Postoperative Pain and Disability Scale (Body-PPDS) will be used to quantify pain
4 secondary outcomes
Early postoperative pain (Visual analogue pain scale)
Time frame: 0, 2, 4, 6, 12 and 24 h after surgery
Early postoperative pain (Time to first request for supplemental analgesia)
Time frame: 1 day
Disability (Time delay in returning to work)
Time frame: 90 days
Postoperative Chronic Pain (McGill scale)
Time frame: Day after surgery, 7, 30 and 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline, Ketamine and Ketamine + magnesium in people with Pain, Postoperative, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioids consumption (time frame: 12 h after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.