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IRCT20190703044091N1 IRCT 2020-09-14 Shahid Beheshti University of Medical Sciences Effects of magnesium sulfate and pregabalin on postoperative pain in posterior lumbar spinal fusion surgery Analgesic effects of combination of preoperative intravenous magnesium sulfate and oral pregabalin on postoperative pain in patients undergoing posterior lumbar spinal fusion surgery 2020-09-19 anticipated 80 Complete https://irct.ir/trial/43712 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients in the present study will be randomized using the sealed opaque envelope. All patients, investigators, outcome assessors, and medical staff, in the present study will be blinded to the study intervention. Study drugs and placebo will be indistinguishable during the course of the study, Blinding description: All patients, investigators, outcome assessors, and medical staff, in the present study will be blinded to the study intervention. 3 Fusion of spine, lumbar region. Intervention 1: Intervention group 1: Patients in this group (MP) will receive preoperative intravenous infusion of 50 mg/kg magnesium sulfate mixed with 200 ml of normal saline and 300 mg pregabalin orally. All the medications will be administered 1 hour before the operation. Infusions will be given over 30 minutes. Intervention 2: Intervention group 2: Patients in this group (M) will receive preoperative intravenous infusion of 50 mg/kg magnesium sulfate mixed with 200 ml and a placebo capsule. All the medications will be administered 1 hour before the operation. Infusions will be given over 30 minutes. Intervention 3: Intervention group 3: Patients in this group (P) will receive preoperative intravenous infusion of 200 ml of normal saline and 300 mg pregabalin orally. All the medications will be administered 1 hour before the operation. Infusions will be given over 30 minutes. Intervention 4: Control group: Patients in this group (C) will receive preoperative intravenous infusion of 200 ml of normal saline and a placebo capsule. All the medications will be administered 1 hour before the operation. Infusions will be given over 30 minutes. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Roozbeh Tavanaei
Functional Neurosurgery Research Center (FNRC), SBMU Shohada-E-Tajrish Educational Hospital, Tajrish Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2270 1022 rtavanaei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Saeed Oraee-Yazdani
Functional Neurosurgery Research Center (FNRC), SBMU Shohada-E-Tajrish Educational Hospital, Tajrish Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2270 1022 saeed_o_yazdani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients between the ages of 18 and 70 years Patients undergoing posterior lumbar spinal fusion surgery 18 years 70 years Both Patients with hepatic dysfunction (transaminases above normal levels) and renal failure (creatinine >150 μmol/l) Cardiac dysfunction (ejection fraction <40) Neurological disorder, myopathy, or history of psychological disorder (e.g. current treatment with antipsychotic and antidepressant medications) Known sensitivity or contraindication to dugs used in the study Preoperative opioid use or regular opioid use due to chronic pain (pain more than 3 months) Preoperative administration of calcium channel blocker Hypermagnesemia M43.26 Fusion of spine, lumbar region Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Patients in this group (MP) will receive preoperative intravenous infusion of 50 mg/kg magnesium sulfate mixed with 200 ml of normal saline and 300 mg pregabalin orally. All the medications will be administered 1 hour before the operation. Infusions will be given over 30 minutes. Intervention group 2: Patients in this group (M) will receive preoperative intravenous infusion of 50 mg/kg magnesium sulfate mixed with 200 ml and a placebo capsule. All the medications will be administered 1 hour before the operation. Infusions will be given over 30 minutes. Intervention group 3: Patients in this group (P) will receive preoperative intravenous infusion of 200 ml of normal saline and 300 mg pregabalin orally. All the medications will be administered 1 hour before the operation. Infusions will be given over 30 minutes. Control group: Patients in this group (C) will receive preoperative intravenous infusion of 200 ml of normal saline and a placebo capsule. All the medications will be administered 1 hour before the operation. Infusions will be given over 30 minutes. Comulative morphine consumption. Timepoint: Baseline (before the operation), 4, 8, 12, 24 hours postoperatively. Method of measurement: Cumulative morphine consumption by assessing the patient controlled analgesia (PCA) pump. Visual analogue scale (VAS, 0-10) for pain at rest. Timepoint: Baseline (before the operation), 4, 8, 12, 24 hours postoperatively. Method of measurement: Visual analogue scale. Posoperative nausea and vomiting (PONV). Timepoint: In 24 hours postoperatively. Method of measurement: Number of episodes patient experiencing nausea and vomiting. Ramsay sedation scale (RSS). Timepoint: Baseline (before the operation), 4, 8, 12, 24 hours postoperatively. Method of measurement: Patients will be divided into 6 groups according to their level of sedation (from severe agitation to deep coma). Shahid Beheshti University of Medical Sciences Approved 2020-08-09 Ethics committee of Shahid Beheshti University of Medical Sciences Shohada-e-Tajrish Hospital, Qods Sq., Tajrish, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)