Comparison of Postoperative Analgesic Effect of Intrathecal Magnesium and Fentanyl Added to Bupivacaine in Patients Undergoing Lower Limb Orthopedic Surgery
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Magnesium has been suggested that NMDA (N-methyl D-aspartate)receptor antagonists induce
      preemptive analgesia when administrated before tissue injury , thus decreasing the subsequent
      sensation of pain.

      Following Ethics Committee approval and informed patients consent, Ninety patients 20-60 yr
      old ASA physical status I or II, scheduled for femur surgery under spinal anesthesia, were
      studied in a prospective, double-blinded, randomized way. The patients were randomly
      allocated to one of three groups of 30 each. The magnesium group (groupM) received
      bupivacaine 15mg combined with 0.5ml magnesium 10%,the fentanyl group (group F) received
      bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and the placebo group (group P)
      received bupivacaine 15mg combined with 0.5ml distilled water intrathecally . Time to first
      requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset
      of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension,
      ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen (SpO2)<90],
      postoperative analgesic requirements and Adverse events, such as sedation, dizziness ,
      Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed
      preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum
      imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a
      supplement analgesic, methadon5 mg intravenously , was to be given for post-operative pain
      relief as needed .
    


Intervention name(s): Fentanyl; placebo(distilled water); magnesium sulphate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery); Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery); Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery)
Intervention MeSH terms: Magnesium Sulfate; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: magnesium; fentanyl; intrathecal; pain