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Comparison of Postoperative Analgesic Effect of Intrathecal Magnesium and Fentanyl Added to Bupivacaine in Patients Undergoing Lower Limb Orthopedic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
marzieh beigom khezri, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01205997
First received: September 20, 2010
Last updated: October 10, 2012
Last verified: October 2012

September 20, 2010
October 10, 2012
August 2010
December 2010   (final data collection date for primary outcome measure)
  • Time to first requirement of analgesic supplement [ Time Frame: time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution ] [ Designated as safety issue: Yes ]
    analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
  • postoperative analgesic requirements [ Time Frame: 12 hours postoperative ] [ Designated as safety issue: Yes ]
    postoperative analgesic requirements will be assessed by verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain).Each administration was initiated by patient request( VRS>4)
Same as current
Complete list of historical versions of study NCT01205997 on ClinicalTrials.gov Archive Site
  • Sensory block onset time will be assessed by a pinprick test [ Time Frame: sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection ] [ Designated as safety issue: Yes ]
    The onset of sensory block was defined as the time between the end of injection of the intrathecal anesthetic and the absence of pain at the T10 dermatome
  • duration of sensory block will be assessed by a pinprick test [ Time Frame: sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection ] [ Designated as safety issue: Yes ]
    The duration of sensory block was defined as the time between the end of injection of the intrathecal anestheticthe time and regression of two segments from the maximum block height
  • the onset of motor block will be assessed by the modified Bromage score [ Time Frame: every10 seconds following intrathecal injection ] [ Designated as safety issue: Yes ]
    The onset of motor block was defined as the time between the end of injection of the intrathecal anesthetic to Bromage block 1
  • duration of motor block will be assessed by the modified Bromage score [ Time Frame: every 5 minuts following intrathecal injection ] [ Designated as safety issue: Yes ]
    duration of motor block was defined the time from intrathecal injection to Bromage score0
  • hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 5min before the intrathecal injection ] [ Designated as safety issue: Yes ]
  • hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 2minutes after intrathecal injection ] [ Designated as safety issue: Yes ]
  • hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 4minutes after intrathecal injection ] [ Designated as safety issue: Yes ]
  • hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 6minutes after intrathecal injection ] [ Designated as safety issue: Yes ]
  • hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 8minutes after intrathecal injection ] [ Designated as safety issue: Yes ]
  • hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 10minutes after intrathecal injection ] [ Designated as safety issue: Yes ]
  • hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 15minutes after intrathecal injection ] [ Designated as safety issue: Yes ]
  • hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 20minutes after intrathecal injection ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Postoperative Analgesic Effect of Intrathecal Magnesium and Fentanyl Added to Bupivacaine in Patients Undergoing Lower Limb Orthopedic Surgery
The Effects of Intrathecal Magnesium and Fentanyl Added to Bupivacaine on Postoperative Analgesic Requirement in Patients Undergoing Lower Limb Orthopedic Surgery

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 .

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Post Operative Pain
  • Drug: Fentanyl
    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)
  • Drug: placebo(distilled water)
    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)
  • Drug: magnesium sulphate
    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)
  • Active Comparator: fentanyl
    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: Drug: Fentanyl
  • Placebo Comparator: placebo
    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: Drug: placebo(distilled water)
  • Active Comparator: magnesium sulphate
    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: Drug: magnesium sulphate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
January 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01205997
ACTRN12610000757011
Yes
marzieh beigom khezri, Qazvin University Of Medical Sciences
Qazvin University Of Medical Sciences
Not Provided
Principal Investigator: Marzieh Beigom Khezri, assistant professor Qazvin medical science university
Qazvin University Of Medical Sciences
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP