Postoperative PainPhase 4NCT02309879
Effect of Infusion of Lidocaine, Magnesium and Remifentanil Perioperatively in Patients Undergoing Mastectomy
A Phase 4 study testing Remifentanil infusion, Lidocaine infusion and Magnesium sulphate infusion in people with Postoperative Pain, run by Hospital de Base at 1 site in Brazil.
Trial summary
This study aims to compare the quality of perioperative analgesia of lidocaine, magnesium sulphate and remifentanil in patients undergoing mastectomy Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Remifentanil infusion, Lidocaine infusion and Magnesium sulphate infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Jul 2015
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients scheduled for elective surgery performed mastectomy;
- Physical Status P1 and P2 of the American Society of Anesthesiology (ASA);
Who cannot join
- Patients with less than 18 years and above 75 years of age;
- Patients who are allergic to morphine and / or lidocaine and / or remifentanil and / or magnesium sulphate;
- Patients with chronic pain;
- Patients with severe hepatic disease;
- Patients with severe renal disease;
- Patients with neurological disorders;
Show all 9Show fewer
- Patients included in other clinical currently or within the past three months under general anesthesia studies;
- Patients who refuse to participate in the study;
- Any other condition that in the opinion of the investigator, may pose a risk to the patient or interfere with the study objectives;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Base do Distrito Federal
Brasília, Federal District, 70680250
About this study
Official title: Effect of Intravenous Infusion of Lidocaine, Magnesium Sulphate and Remifentanil Perioperatively in Patients Undergoing Mastectomy: a Prospective, Randomized and Double-blind Study
This study aims to compare the quality of perioperative analgesia of lidocaine, magnesium sulphate and remifentanil in patients undergoing mastectomy
Read the detailed description
The opioid analgesics are commonly used in clinical practice for pain management in the perioperative period. However, many side effects are associated with its use, such as respiratory depression, nausea, vomiting, drowsiness, itching, urinary retention, constipation, hyperalgesia and impaired immune function. Therefore, alternative techniques and drugs have been used to replace their use. One is the intravenous infusion of lidocaine, a local anesthetic widely used in anesthetic practice. Another is intravenous infusion of magnesium sulphate, a bivalent salt used as a central nervous system depressor, reducing intracranial hypertension, in the treatment of epilepsy; eclampsia; in chronic alcoholism; in hyaline membranes, such as hyperosmotic diuretic; in malnutrition; hypomagnesaemia; in thrombotic microangiopathy; in sickle cell anemia, uterine tetany and atypical ventricular tachycardia. Studies show that the use alone or combined of lidocaine and magnesium sulphate during surgery significantly decreased postoperative pain. The mechanisms of analgesia this local anesthetic in surgical trauma may be blocking neuronal transmission in the lesion site alleviating neurogenic response, and anti-inflammatory systemic intrinsic activity. Intraoperative lidocaine promotes, besides analgesia, decreased consumption of both inhalational anesthetic and opioids; faster return of bowel movements; decreasing the production of interleukins and reduction of airway reactivity. This anesthetic also has significant anti-inflammatory properties, reduces cytokine release both in vitro and in vivo by inhibiting neutrophil activation. N-methyl-D-aspartate (NMDA) receptors are critically involved in the induction and maintenance of neuronal hyperexcitability after traumatic events, therefore, the use of NMDA antagonists before the incision reduces the excitability of the central nervous system and its result is the reduction of clinical hyperalgesia. Magnesium sulphate is an antagonist of glutamate NMDA receptor, which gives analgesic, anticonvulsant and sedative. It acts as a natural physiological calcium antagonist regulating access to the intracellular space. Shows the effect of muscle relaxation by inhibiting the release of acetylcholine at the neuromuscular junction, thereby hypermagnesaemia decreases sensitivity to acetylcholine of the endplate and the potential amplitude endplate. Besides there are few studies with use of these adjuvants during the perioperative period, the intravenous injection of local anesthetic still arouses oddity among professionals; therefore, the investigators interest in the subject.
The patients underwent a prospective, randomized, double blind study, in which the examiners responsible for intra and post-operative will not know which group they were randomly allocated: Lidocaine group (n = 30); Lidocaine and Magnesium group (n = 30); Magnesium group (n = 30) or Remifentanil group (n = 30). Rapid infusion of 0.9% saline 500 ml, in the M and LM group, is added to this solution the loading dose of magnesium sulfate with 50 mg/kg and in group L will only be infused saline 0.9% . Two infusion pumps containing the result of randomization: Lidocaine 3 mg/kg/h and 0.9% saline (L group); magnesium sulphate 15 mg/kg/h and 0.9% saline (M group); lidocaine 3 mg/kg/h and magnesium sulphate 15 mg/kg/hr (LM group); and Remifentanil group (R group).
In the clinical record, the following information will be emphasized: Blood pressure and heart rate intraoperative, perioperative side effects, quantify pain by Visual Analogue Scale (VAS) (ranging from 0 to 10 cm, zero being found when the patient is no pain and ten, with maximum or unbearable pain), Verbal Rating Scale (VRS), consisting of a list of phrases (no pain, mild pain, moderate pain, intense pain, maximum pain) and qualification of pain assessed by the amount of analgesics required postoperatively and the time to request them.
The results were analyzed statistically with the Statistical Package for Social Sciences (SPSS) version 22 (SPSS Inc., Chicago, IL, EUA) using parametric and nonparametric tests, depending on the nature of the variables studied. Data were tested for normality using the Shapiro-Wilk test. Measures of central tendency (means) and dispersion (standard deviation) were used. The level of significance was set at < 0.05. The following tests were used: Mann-Whitney test for age, duration of anesthesia and surgery, time to first analgesic supplementation, total amount of analgesics, pain intensity; Student t-test for weight and height.
- Conditions
- Postoperative Pain
- Being tested
- Remifentanil infusion, Lidocaine infusion, Magnesium sulphate infusion, Magnesium sulphate and Lidocaine infusion
- Keywords
- Intravenous lidocaine, Magnesium sulphate, Mastectomy, Pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil infusionDrug
Also called Remifentanil hydrochloride
Patients in Remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min.
Lidocaine infusionDrug
Also called Lidocaine hydrochloride
Patients in Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr.
Magnesium sulphate infusionDrug
Also called Magnesium sulphate
Patients in Magnesium group received an intravenous bolus injection of 50 mg/kg magnesium sulphate plus an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous magnesium sulphate infusion of 15 mg/kg/hr.
Magnesium sulphate and Lidocaine infusionDrug
Also called Magnesium sulphate, Lidocaine hydrochloride
Patients in Magnesium and Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine plus 50 mg/kg magnesium sulphate followed by a continuous lidocaine infusion of 3 mg/kg/hr plus 15 mg/kg/hr magnesium sulphate
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil group | Active comparator | Patients in remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min. Receives: Drug: Remifentanil infusion; Drug: Lidocaine infusion; Drug: Magnesium sulphate infusion; Drug: Magnesium sulphate and Lidocaine infusion |
| Lidocaine group | Active comparator | Patients in lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr. Receives: Drug: Remifentanil infusion; Drug: Lidocaine infusion; Drug: Magnesium sulphate infusion; Drug: Magnesium sulphate and Lidocaine infusion |
| Magnesium group | Active comparator | Patients in lidocaine group received an intravenous bolus injection of 50 mg/kg magnesium sulphate followed by a continuous magnesium sulphate infusion of 15 mg/kg/hr. Receives: Drug: Remifentanil infusion; Drug: Lidocaine infusion; Drug: Magnesium sulphate infusion; Drug: Magnesium sulphate and Lidocaine infusion |
| Magnesium and Lidocaine group | Active comparator | Patients received an intravenous bolus injection of 2 mg/kg lidocaine plus 50 mg/kg magnesium sulphate followed by a continuous lidocaine infusion of 3 mg/kg/hr plus 15 mg/kg/hr magnesium sulphate Receives: Drug: Remifentanil infusion; Drug: Lidocaine infusion; Drug: Magnesium sulphate infusion; Drug: Magnesium sulphate and Lidocaine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesics consumption in post-operative
Qualification of pain assessed by the amount of analgesics required postoperatively and the time to request them
Measured: Within the first 24 hours after surgery
Secondary outcomes (5)
Pain Scores on the Visual Analog Scale
Quantify pain by Visual Analogue Scale (VAS, ranging from 0 to 10 cm, zero being found when the patient is no pain and ten, with maximum or unbearable pain)
Measured: Within the first 24 hours after surgery
Pain Scores on the Verbal Rating Scale
Verbal Rating Scale (VRS), consisting of a list of phrases (no pain, mild pain, moderate pain, intense pain, maximum pain)
Measured: Within the first 24 hours after surgery
Anesthetic consumption during surgery
amount of intravenous and inhalational anesthetics consumed during surgery
Measured: During the surgery
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Intraoperative hemodynamic stability analysis through the incidence of tachycardia, hypertension, bradycardia, hypotension and consumed vasopressors
Measured: During the surgery
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Incidence of adverse effects such as time of awakening, nausea, vomiting, pruritus, urinary retention, drowsiness
Measured: Within the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Base
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabricio Tavares Mendonca, Hospital de Base
- Investigators
- Fabricio T Mendonca, MD, TSA, Principal investigator, Hospital de Base do Distrito Federal, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309879
- Sponsor's protocol ID
- LidovsMgvsRemi
- Status last verified
- Aug 2015
- First submitted
- 28 Nov 2014
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
De 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 23669270Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.
PubMed 21061107Mendonca FT, Pellizzaro D, Grossi BJ, Calvano LA, de Carvalho LSF, Sposito AC. Synergistic effect of the association between lidocaine and magnesium sulfate on peri-operative pain after mastectomy: A randomised, double-blind trial. Eur J Anaesthesiol. 2020 Mar;37(3):224-234. doi: 10.1097/EJA.0000000000001153.
PubMed 31977625
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Infusion of Lidocaine, Magnesium Sulphate and Remifentanil Perioperatively in Patients Undergoing Mastectomy: a Prospective, Randomized and Double-blind Study
- ClinicalTrials.gov ID
- NCT02309879
- Acronym / sponsor ID
- LidovsMgvsRemi
- Conditions
- Postoperative Pain
- Keywords
- Intravenous lidocaine, Magnesium sulphate, Mastectomy, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 Dec 2014 (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.
This study aims to compare the quality of perioperative analgesia of lidocaine, magnesium sulphate and remifentanil in patients undergoing mastectomy
Detailed description
The opioid analgesics are commonly used in clinical practice for pain management in the perioperative period. However, many side effects are associated with its use, such as respiratory depression, nausea, vomiting, drowsiness, itching, urinary retention, constipation, hyperalgesia and impaired immune function. Therefore, alternative techniques and drugs have been used to replace their use. One is the intravenous infusion of lidocaine, a local anesthetic widely used in anesthetic practice. Another is intravenous infusion of magnesium sulphate, a bivalent salt used as a central nervous system depressor, reducing intracranial hypertension, in the treatment of epilepsy; eclampsia; in chronic alcoholism; in hyaline membranes, such as hyperosmotic diuretic; in malnutrition; hypomagnesaemia; in thrombotic microangiopathy; in sickle cell anemia, uterine tetany and atypical ventricular tachycardia. Studies show that the use alone or combined of lidocaine and magnesium sulphate during surgery significantly decreased postoperative pain. The mechanisms of analgesia this local anesthetic in surgical trauma may be blocking neuronal transmission in the lesion site alleviating neurogenic response, and anti-inflammatory systemic intrinsic activity. Intraoperative lidocaine promotes, besides analgesia, decreased consumption of both inhalational anesthetic and opioids; faster return of bowel movements; decreasing the production of interleukins and reduction of airway reactivity. This anesthetic also has significant anti-inflammatory properties, reduces cytokine release both in vitro and in vivo by inhibiting neutrophil activation. N-methyl-D-aspartate (NMDA) receptors are critically involved in the induction and maintenance of neuronal hyperexcitability after traumatic events, therefore, the use of NMDA antagonists before the incision reduces the excitability of the central nervous system and its result is the reduction of clinical hyperalgesia. Magnesium sulphate is an antagonist of glutamate NMDA receptor, which gives analgesic, anticonvulsant and sedative. It acts as a natural physiological calcium antagonist regulating access to the intracellular space. Shows the effect of muscle relaxation by inhibiting the release of acetylcholine at the neuromuscular junction, thereby hypermagnesaemia decreases sensitivity to acetylcholine of the endplate and the potential amplitude endplate. Besides there are few studies with use of these adjuvants during the perioperative period, the intravenous injection of local anesthetic still arouses oddity among professionals; therefore, the investigators interest in the subject.
The patients underwent a prospective, randomized, double blind study, in which the examiners responsible for intra and post-operative will not know which group they were randomly allocated: Lidocaine group (n = 30); Lidocaine and Magnesium group (n = 30); Magnesium group (n = 30) or Remifentanil group (n = 30). Rapid infusion of 0.9% saline 500 ml, in the M and LM group, is added to this solution the loading dose of magnesium sulfate with 50 mg/kg and in group L will only be infused saline 0.9% . Two infusion pumps containing the result of randomization: Lidocaine 3 mg/kg/h and 0.9% saline (L group); magnesium sulphate 15 mg/kg/h and 0.9% saline (M group); lidocaine 3 mg/kg/h and magnesium sulphate 15 mg/kg/hr (LM group); and Remifentanil group (R group).
In the clinical record, the following information will be emphasized: Blood pressure and heart rate intraoperative, perioperative side effects, quantify pain by Visual Analogue Scale (VAS) (ranging from 0 to 10 cm, zero being found when the patient is no pain and ten, with maximum or unbearable pain), Verbal Rating Scale (VRS), consisting of a list of phrases (no pain, mild pain, moderate pain, intense pain, maximum pain) and qualification of pain assessed by the amount of analgesics required postoperatively and the time to request them.
The results were analyzed statistically with the Statistical Package for Social Sciences (SPSS) version 22 (SPSS Inc., Chicago, IL, EUA) using parametric and nonparametric tests, depending on the nature of the variables studied. Data were tested for normality using the Shapiro-Wilk test. Measures of central tendency (means) and dispersion (standard deviation) were used. The level of significance was set at < 0.05. The following tests were used: Mann-Whitney test for age, duration of anesthesia and surgery, time to first analgesic supplementation, total amount of analgesics, pain intensity; Student t-test for weight and height.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Remifentanil group | Active comparator | Drug: Remifentanil infusion, Drug: Lidocaine infusion, Drug: Magnesium sulphate infusion, Drug: Magnesium sulphate and Lidocaine infusionPatients in remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min. |
| Lidocaine group | Active comparator | Drug: Remifentanil infusion, Drug: Lidocaine infusion, Drug: Magnesium sulphate infusion, Drug: Magnesium sulphate and Lidocaine infusionPatients in lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr. |
| Magnesium group | Active comparator | Drug: Remifentanil infusion, Drug: Lidocaine infusion, Drug: Magnesium sulphate infusion, Drug: Magnesium sulphate and Lidocaine infusionPatients in lidocaine group received an intravenous bolus injection of 50 mg/kg magnesium sulphate followed by a continuous magnesium sulphate infusion of 15 mg/kg/hr. |
| Magnesium and Lidocaine group | Active comparator | Drug: Remifentanil infusion, Drug: Lidocaine infusion, Drug: Magnesium sulphate infusion, Drug: Magnesium sulphate and Lidocaine infusionPatients received an intravenous bolus injection of 2 mg/kg lidocaine plus 50 mg/kg magnesium sulphate followed by a continuous lidocaine infusion of 3 mg/kg/hr plus 15 mg/kg/hr magnesium sulphate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients scheduled for elective surgery performed mastectomy;
- Physical Status P1 and P2 of the American Society of Anesthesiology (ASA);
Key exclusion criteria (9 listed)
- Patients with less than 18 years and above 75 years of age;
- Patients who are allergic to morphine and / or lidocaine and / or remifentanil and / or magnesium sulphate;
- Patients with chronic pain;
- Patients with severe hepatic disease;
- Patients with severe renal disease;
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 |
|---|---|---|
| Remifentanil infusionAlso: Remifentanil hydrochloridePatients in Remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min. | Drug | Lidocaine group, Magnesium and Lidocaine group, Magnesium group, Remifentanil group |
| Lidocaine infusionAlso: Lidocaine hydrochloridePatients in Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr. | Drug | Lidocaine group, Magnesium and Lidocaine group, Magnesium group, Remifentanil group |
| Magnesium sulphate infusionAlso: Magnesium sulphatePatients in Magnesium group received an intravenous bolus injection of 50 mg/kg magnesium sulphate plus an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous magnesium sulphate infusion of 15 mg/kg/hr. | Drug | Lidocaine group, Magnesium and Lidocaine group, Magnesium group, Remifentanil group |
| Magnesium sulphate and Lidocaine infusionAlso: Magnesium sulphate, Lidocaine hydrochloridePatients in Magnesium and Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine plus 50 mg/kg magnesium sulphate followed by a continuous lidocaine infusion of 3 mg/kg/hr plus 15 mg/kg/hr magnesium sulphate | Drug | Lidocaine group, Magnesium and Lidocaine group, Magnesium group, Remifentanil group |
Primary outcome
Analgesics consumption in post-operative
Time frame: Within the first 24 hours after surgery
Qualification of pain assessed by the amount of analgesics required postoperatively and the time to request them
5 secondary outcomes
Pain Scores on the Visual Analog Scale
Time frame: Within the first 24 hours after surgery
Pain Scores on the Verbal Rating Scale
Time frame: Within the first 24 hours after surgery
Anesthetic consumption during surgery
Time frame: During the surgery
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: During the surgery
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Within the first 24 hours 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 19 Aug 2015.
- Background: 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.
- Background: PubMed 21061107Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.
- Derived from this study: PubMed 31977625Mendonca FT, Pellizzaro D, Grossi BJ, Calvano LA, de Carvalho LSF, Sposito AC. Synergistic effect of the association between lidocaine and magnesium sulfate on peri-operative pain after mastectomy: A randomised, double-blind trial. Eur J Anaesthesiol. 2020 Mar;37(3):224-234. doi: 10.1097/EJA.0000000000001153.
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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.
Fabricio T Mendonca, MD, TSA principal investigator
Hospital de Base do Distrito Federal, Brazil
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 Remifentanil infusion, Lidocaine infusion and Magnesium sulphate infusion in people with Postoperative Pain, run by Hospital de Base 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 2 inclusion and 9 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 19 Aug 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. 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?
Analgesics consumption in post-operative (time frame: Within the first 24 hours after surgery). 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 NCT02309879, which also lists 3 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 19 Aug 2015.