Comparison of Postoperative Analgesic Effect of Intrathecal Magnesium and Fentanyl Added to Bupivacaine in Patients Undergoing Lower Limb Orthopedic Surgery
Information source: Qazvin University Of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Operative Pain
Intervention: Fentanyl (Drug); placebo(distilled water) (Drug); magnesium sulphate (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Qazvin University Of Medical Sciences Official(s) and/or principal investigator(s): Marzieh Beigom Khezri, assistant professor, Principal Investigator, Affiliation: Qazvin medical science university
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 .
Clinical Details
Official title: The Effects of Intrathecal Magnesium and Fentanyl Added to Bupivacaine on Postoperative Analgesic Requirement in Patients Undergoing Lower Limb Orthopedic Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Time to first requirement of analgesic supplementpostoperative analgesic requirements
Secondary outcome: Sensory block onset time will be assessed by a pinprick testduration of sensory block will be assessed by a pinprick test the onset of motor block will be assessed by the modified Bromage score duration of motor block will be assessed by the modified Bromage score hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Eligibility
Minimum age: 20 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
.patients with American Society of Anesthesiologists(ASA) physical status I and
II, undergoing elective femur surgery
-
Exclusion Criteria:
- significant coexisting disease such as hepato-renal and cardiovascular disease
- any contraindication to regional anesthesia such as local infection or ````bleeding
disorders
- allergy to opioids
- long-term opioid use
- history of chronic pain.
Locations and Contacts
Qazvin university of medical science, Qazvin 34197/59811, Iran, Islamic Republic of
Additional Information
Starting date: August 2010
Last updated: October 10, 2012
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