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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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;
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  • 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

Other trials in Brazil

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.

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 groups in NCT02309879
Study groupRoleWhat they receive
Remifentanil groupActive comparatorPatients 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 groupActive comparatorPatients 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 groupActive comparatorPatients 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 groupActive comparatorPatients 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.

  1. 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)
  1. 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

  2. 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

  3. Anesthetic consumption during surgery

    amount of intravenous and inhalational anesthetics consumed during surgery

    Measured: During the surgery

  4. 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

  5. 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.

  1. First posted5 Dec 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

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)
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 23669270
  • Vigneault 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 21061107
  • Mendonca 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

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.

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