Pain, PostoperativePhase 4MagnesiumNCT02508857
Magnesium Sulfate Improves Postoperative Analgesia in Laparoscopic Gynecologic Surgeries
A Phase 4 study testing Ketorolac, Magnesium and Saline solution in people with Pain, Postoperative, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
Magnesium sulfate has been reported to improve postoperative pain, but evidence is still controversial. Some studies demonstrated benefits while others concluded that there is no efficacy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ketorolac, Magnesium and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Jan 2014
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II female patients undergoing laparoscopic gynecologic oncology surgeries, for treatment of cancer
Who cannot join
- chronic pain, cardiovascular, hepatic or renal disease, neuromuscular disease, diabetes, drugs or alcohol abuse, obesity, patients treated with calcium channel blockers or magnesium, allergy or contraindication to any of the drugs studied.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnesium Sulfate Improves Postoperative Analgesia in Laparoscopic Gynecologic Surgeries: a Double-blind Randomized Controlled Trial.
Magnesium sulfate has been reported to improve postoperative pain, but evidence is still controversial. Some studies demonstrated benefits while others concluded that there is no efficacy. Aim: the aim of the study was to compare the effect of intravenous infusion of magnesium sulfate to ketorolac during laparoscopic gynecologic oncology surgeries. Methods: We designed a double-blind randomized controlled trial that compared intravenous magnesium sulfate to ketorolac and saline solution in postoperative pain, morphine consumption and opioid related side effects.
Read the detailed description
Sixty American Society of Anesthesiologists (ASA) I-II patients undergoing laparoscopic gynecologic oncology surgeries are enrolled in this study.
Patients were randomized to receive either intravenous ketorolac 30 mg in bolus followed by saline infusion (Group K), intravenous magnesium sulfate 20 mg/kg in bolus followed by magnesium 2 mg/kg/h (Group M) or intravenous saline solution 20 ml in bolus followed by saline infusion during the entire procedure (Group S). The study use a double-blinded methodology with random allocation into three groups using sealed opaque envelopes numbered 1 to 60, containing the instructions for the study. An independent anesthesiologist not involved in the study prepared the solutions and an observer who was also blinded to the patient's group records the data.
In the preoperative visit, patients that agree to participate are instructed about numeric rating scale (NRS) and the Patient Controlled Analgesia (PCA) device.
The night before surgery, patients are premedicated with midazolam 7.5 mg per os. Upon arrival in the operating room, monitoring devices (ECG, non-invasive arterial pressure, capnography, pulse oximetry) and a bispectral index (BIS) monitor are established. An intravenous line is secured, general intravenous anesthesia is induced with target infusion remifentanil and propofol. Cisatracurium besylate (0.5 mg/kg) is given to facilitate tracheal intubation and controlled ventilation is adjusted to maintain normocapnia with a 50% oxygen fraction administered. Then, the study medications are administered in bolus during 20 minutes, followed by continuous infusion of the specific solution, according to the study group to which the patient belonged, as described before.
At the end of the surgery, the study drugs are discontinued before the patient is extubated. If patients present clinical signs of residual neuromuscular blockade, they receive atropine 0.01mg/kg and neostigmine 0.04mg/kg. All patients receive dipyrone 30 mg/kg in bolus and a PCA device is connected to the intravenous line before discharge to the Post Anesthesia Care Unit (PACU). PCA solution containing morphine 1mg/ml in 0.9% saline, is set to give bolus of 2ml (2mg) with a 10min lockout interval.
In the postoperative period, the anesthesiologist responsible for the study question the intensity of pain in the patients using two methods: numerical rating scale (NRS) (0=no pain and 10=worst pain imaginable) and descriptive verbal scale (no pain, mild pain, moderate pain or severe pain - at emergence from anesthesia and after 20, 30 and 60 minutes, while in PACU. Patients are instructed to use the PCA device whenever they feel pain. Agitation and Sedation are monitored using RASS scale and patient is considered sedated if RASS ≤ -1. Episodes of nausea, vomiting, respiratory depression or pruritus are also recorded.
Patients are discharged to the ward after 60 minutes, if minimum criteria for discharge are met.
Time (in minutes) to the first morphine rescue, and total consumption of morphine in PACU are registered. After 24 hours, pain intensity score, total morphine consumption and side effects are also recorded and PCA device is disconnected.
- Conditions
- Pain, Postoperative
- Being tested
- Ketorolac, Magnesium, Saline solution
- Keywords
- pain, postoperative, anesthesia adjuvants, magnesium sulfate
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Toradol
Patients received intravenous injection of ketorolac (30 mg) in bolus; then, saline solution was continuously infused during the entire procedure (Group K),
MagnesiumDrug
Also called Magnesium sulfate
Patients received intravenous magnesium sulfate (20 mg/kg) in bolus, then magnesium sulfate (2 mg/kg/h) was continuously injected during the procedure (Group M)
Saline solutionDrug
Also called Sodium chloride
intravenous saline solution (20 ml) was injected in bolus, followed by continuous infusion of saline solution during the entire procedure (Group S).
| Study group | Role | What they receive |
|---|---|---|
| ketorolac | Active comparator | intravenous ketorolac (30 mg) is injected in bolus, followed by continuous infusion of saline solution (Group K) during the surgical procedure Receives: Drug: Ketorolac |
| magnesium | Experimental | intravenous magnesium sulfate (20 mg/kg) is injected in bolus, followed by continuous infusion of magnesium sulfate (2 mg/kg/h) (Group M) during the surgical procedure Receives: Drug: Magnesium |
| saline | Placebo comparator | intravenous saline solution (20 ml) is injected in bolus, followed by continuous infusion of saline infusion during the entire procedure (Group S). Receives: Drug: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
intensity of pain in the patients using numerical rating scale (NRS) (0=no pain and 10=worst pain imaginable) and descriptive verbal scale (no pain, mild pain, moderate pain or severe pain
Measured: 24 hours
Secondary outcomes (2)
time to first morphine rescue
Time (in minutes) to the first dose of morphine
Measured: first 6 hours
morphine consumption
total consumption of morphine in PACU
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startJan 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- angela m sousa, phD, Principal investigator, Cancer Institute of the State of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508857
- Sponsor's protocol ID
- NP0792010
- Acronym
- Magnesium
- Status last verified
- Jul 2015
- First submitted
- 27 Apr 2015
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1.
PubMed 23121612De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.
PubMed 23669270
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulfate Improves Postoperative Analgesia in Laparoscopic Gynecologic Surgeries: a Double-blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02508857
- Acronym / sponsor ID
- Magnesium / NP0792010
- Conditions
- Pain, Postoperative
- Keywords
- pain, postoperative, anesthesia adjuvants, magnesium sulfate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Jul 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.
Magnesium sulfate has been reported to improve postoperative pain, but evidence is still controversial. Some studies demonstrated benefits while others concluded that there is no efficacy. Aim: the aim of the study was to compare the effect of intravenous infusion of magnesium sulfate to ketorolac during laparoscopic gynecologic oncology surgeries. Methods: We designed a double-blind randomized controlled trial that compared intravenous magnesium sulfate to ketorolac and saline solution in postoperative pain, morphine consumption and opioid related side effects.
Detailed description
Sixty American Society of Anesthesiologists (ASA) I-II patients undergoing laparoscopic gynecologic oncology surgeries are enrolled in this study.
Patients were randomized to receive either intravenous ketorolac 30 mg in bolus followed by saline infusion (Group K), intravenous magnesium sulfate 20 mg/kg in bolus followed by magnesium 2 mg/kg/h (Group M) or intravenous saline solution 20 ml in bolus followed by saline infusion during the entire procedure (Group S). The study use a double-blinded methodology with random allocation into three groups using sealed opaque envelopes numbered 1 to 60, containing the instructions for the study. An independent anesthesiologist not involved in the study prepared the solutions and an observer who was also blinded to the patient's group records the data.
In the preoperative visit, patients that agree to participate are instructed about numeric rating scale (NRS) and the Patient Controlled Analgesia (PCA) device.
The night before surgery, patients are premedicated with midazolam 7.5 mg per os. Upon arrival in the operating room, monitoring devices (ECG, non-invasive arterial pressure, capnography, pulse oximetry) and a bispectral index (BIS) monitor are established. An intravenous line is secured, general intravenous anesthesia is induced with target infusion remifentanil and propofol. Cisatracurium besylate (0.5 mg/kg) is given to facilitate tracheal intubation and controlled ventilation is adjusted to maintain normocapnia with a 50% oxygen fraction administered. Then, the study medications are administered in bolus during 20 minutes, followed by continuous infusion of the specific solution, according to the study group to which the patient belonged, as described before.
At the end of the surgery, the study drugs are discontinued before the patient is extubated. If patients present clinical signs of residual neuromuscular blockade, they receive atropine 0.01mg/kg and neostigmine 0.04mg/kg. All patients receive dipyrone 30 mg/kg in bolus and a PCA device is connected to the intravenous line before discharge to the Post Anesthesia Care Unit (PACU). PCA solution containing morphine 1mg/ml in 0.9% saline, is set to give bolus of 2ml (2mg) with a 10min lockout interval.
In the postoperative period, the anesthesiologist responsible for the study question the intensity of pain in the patients using two methods: numerical rating scale (NRS) (0=no pain and 10=worst pain imaginable) and descriptive verbal scale (no pain, mild pain, moderate pain or severe pain - at emergence from anesthesia and after 20, 30 and 60 minutes, while in PACU. Patients are instructed to use the PCA device whenever they feel pain. Agitation and Sedation are monitored using RASS scale and patient is considered sedated if RASS ≤ -1. Episodes of nausea, vomiting, respiratory depression or pruritus are also recorded.
Patients are discharged to the ward after 60 minutes, if minimum criteria for discharge are met.
Time (in minutes) to the first morphine rescue, and total consumption of morphine in PACU are registered. After 24 hours, pain intensity score, total morphine consumption and side effects are also recorded and PCA device is disconnected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ketorolac | Active comparator | Drug: Ketorolacintravenous ketorolac (30 mg) is injected in bolus, followed by continuous infusion of saline solution (Group K) during the surgical procedure |
| magnesium | Experimental | Drug: Magnesiumintravenous magnesium sulfate (20 mg/kg) is injected in bolus, followed by continuous infusion of magnesium sulfate (2 mg/kg/h) (Group M) during the surgical procedure |
| saline | Placebo comparator | Drug: Saline solutionintravenous saline solution (20 ml) is injected in bolus, followed by continuous infusion of saline infusion during the entire procedure (Group S). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-II female patients undergoing laparoscopic gynecologic oncology surgeries, for treatment of cancer
Key exclusion criteria (1 listed)
- chronic pain, cardiovascular, hepatic or renal disease, neuromuscular disease, diabetes, drugs or alcohol abuse, obesity, patients treated with calcium channel blockers or magnesium, allergy or contraindication to any of the drugs studied.
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 |
|---|---|---|
| KetorolacAlso: ToradolPatients received intravenous injection of ketorolac (30 mg) in bolus; then, saline solution was continuously infused during the entire procedure (Group K), | Drug | ketorolac |
| MagnesiumAlso: Magnesium sulfatePatients received intravenous magnesium sulfate (20 mg/kg) in bolus, then magnesium sulfate (2 mg/kg/h) was continuously injected during the procedure (Group M) | Drug | magnesium |
| Saline solutionAlso: Sodium chlorideintravenous saline solution (20 ml) was injected in bolus, followed by continuous infusion of saline solution during the entire procedure (Group S). | Drug | saline |
Primary outcome
postoperative pain
Time frame: 24 hours
intensity of pain in the patients using numerical rating scale (NRS) (0=no pain and 10=worst pain imaginable) and descriptive verbal scale (no pain, mild pain, moderate pain or severe pain
2 secondary outcomes
time to first morphine rescue
Time frame: first 6 hours
morphine consumption
Time frame: 60 minutes
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 27 Jul 2015.
- Results publication: PubMed 23121612Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1.
- Results publication: PubMed 23669270De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.
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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.
angela m sousa, phD principal investigator
Cancer Institute of the State of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac, Magnesium and Saline solution in people with Pain, Postoperative, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 1 inclusion and 1 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 27 Jul 2015. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
postoperative pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02508857, which also lists 2 linked publications.
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 27 Jul 2015.