Clinical trial NCT01205997: Comparison of Postoperative Analgesic Effect of Intrathecal Magnesium and Fentanyl Added to Bupivacaine in Patients Undergoing Lower Limb Orthopedic Surgery
Official title: The Effects of Intrathecal Magnesium and Fentanyl Added to Bupivacaine on Postoperative Analgesic Requirement in Patients Undergoing Lower Limb Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Post Operative Pain
Keywords: magnesium
fentanyl
intrathecal
pain
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2010-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 .


Eligibility criteria: Inclusion Criteria:

.patients with American Society of Anesthesiologists(ASA) physical status I and

II, undergoing elective femur surgery

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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.

Primary outcomes:
measure: Time to first requirement of analgesic supplement
timeFrame: time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution
measure: postoperative analgesic requirements
timeFrame: 12 hours postoperative
Secondary outcomes:
measure: Sensory block onset time will be assessed by a pinprick test
timeFrame: sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection
measure: duration of sensory block will be assessed by a pinprick test
timeFrame: sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection
measure: the onset of motor block will be assessed by the modified Bromage score
timeFrame: every10 seconds following intrathecal injection
measure: duration of motor block will be assessed by the modified Bromage score
timeFrame: every 5 minuts following intrathecal injection
measure: hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 5min before the intrathecal injection
measure: hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 2minutes after intrathecal injection
measure: hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 4minutes after intrathecal injection
measure: hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 6minutes after intrathecal injection
measure: hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 8minutes after intrathecal injection
measure: hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 10minutes after intrathecal injection
measure: hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 15minutes after intrathecal injection
measure: hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 20minutes after intrathecal injection
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin university of medical science
Study officials:
affiliation: Qazvin medical science university
name: Marzieh Beigom Khezri, assistant professor
role: PRINCIPAL_INVESTIGATOR
References: