Pain in arthroscopic anterior cruciate ligament reconstruction surgery.
Conditions
Interventions
Trade Name: MAGNESIUM SULPHATE ALTAN
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Sponsors
FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients scheduled for anterior cruciate ligament reconstruction surgery via arthroscopy. - ASA I and II patients of both sexes. - Age between 18 and 60 years. - Signed informed consent form agreeing to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 131 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - ASA III or IV patients. - Patients with expected difficult airway. - Patients with the presence of predictive criteria for failed ventilation with supraglottic devices. - Allergy or intolerance to local anaesthetics, morphine or derivatives, magnesium sulphate. - Diabetes mellitus with last control of glycosylated haemoglobin greater than 7%. - Patients with neuromuscular diseases. - Patients with previous treatment with corticoids or calcium antagonists. - Patients with difficulty in understanding the information related to the study and in collaborating in the assessment of pain. - Patients with major psychiatric pathology in DSM-V. - Pregnancy and/or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Magnesium Sulphate via perineural route in prolonging analgesia when administered as an adjuvant to the local anaesthetic Ropivacaine in arthroscopic anterior cruciate ligament reconstruction surgery.;Secondary Objective: - To assess the speed at which anaesthetic block is established. - To measure the depth of regional anaesthesia. - To determine the analgesic efficacy of the block in the immediate postoperative period, as well as during the first 24 hours at home after hospital discharge. - To assess the safety of the technique, in the form of perioperative adverse events. - To determine the level of patient satisfaction.;Primary end point(s): Time in minutes from the time the patient receives the adductor canal block until the first analgesic rescue dose is demanded.;Timepoint(s) of evaluation of this end point: Clinical follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Speed of onset of anaesthetic blockade. - Intraoperative nociception monitoring via the NOL (nociception level) monitor. - Anaesthetic depth. - Visual Analogue Scale (VAS) - Total number of boluses of morphine requested by the patient. - Adverse effects. - Overall patient satisfaction with treatment (PGIC scale).;Timepoint(s) of evaluation of this end point: - From injection to establishment of analgesic blockade. - During the intraoperative period. - Clinical follow-up period - Before undergoing surgery and clinical follow-up period. - Clinical follow-up period. - Clinical follow-up period. - At the end of the clinical follow-up | — |
Countries
Spain
Contacts
Public ContactPAULA CALLEJO GARCÍA
FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD
Outcome results
None listed