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
  Purpose

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 .


Condition Intervention Phase
Post Operative Pain
Drug: Fentanyl
Drug: placebo(distilled water)
Drug: magnesium sulphate
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Intrathecal Magnesium and Fentanyl Added to Bupivacaine on Postoperative Analgesic Requirement in Patients Undergoing Lower Limb Orthopedic Surgery

Resource links provided by NLM:


Further study details as provided by Qazvin University Of Medical Sciences:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)
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)
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)
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)
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)

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01205997

Locations
Iran, Islamic Republic of
Qazvin university of medical science
Qazvin, Iran, Islamic Republic of, 34197/59811
Sponsors and Collaborators
Qazvin University Of Medical Sciences
Investigators
Principal Investigator: Marzieh Beigom Khezri, assistant professor Qazvin medical science university
  More Information

No publications provided

Responsible Party: marzieh beigom khezri, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT01205997     History of Changes
Other Study ID Numbers: ACTRN12610000757011
Study First Received: September 20, 2010
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Qazvin University Of Medical Sciences:
magnesium
fentanyl
intrathecal
pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Magnesium Sulfate
Analgesics
Fentanyl
Bupivacaine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Anesthetics, Local
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous

ClinicalTrials.gov processed this record on October 19, 2014