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NCT Number: NCT01205997

Comparison of Postoperative Analgesic Effect of Intrathecal Magnesium and Fentanyl Added to Bupivacaine 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 .

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Qazvin university of medical science

Qazvin, Qazvin Province, 34197/59811, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fentanyl

Drug

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(distilled water)

Drug

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)

Magnesium sulphate

Drug

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)

Primary outcomes

  1. Time to first requirement of analgesic supplement

    Time frame: time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution

    analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)

  2. postoperative analgesic requirements

    Time frame: 12 hours postoperative

    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 outcomes

  1. 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

    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

  2. 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

    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

  3. the onset of motor block will be assessed by the modified Bromage score

    Time frame: every10 seconds following intrathecal injection

    The onset of motor block was defined as the time between the end of injection of the intrathecal anesthetic to Bromage block 1

  4. duration of motor block will be assessed by the modified Bromage score

    Time frame: every 5 minuts following intrathecal injection

    duration of motor block was defined the time from intrathecal injection to Bromage score0

  5. hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring

    Time frame: 5min before the intrathecal injection

  6. hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring

    Time frame: 2minutes after intrathecal injection

  7. hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring

    Time frame: 4minutes after intrathecal injection

  8. hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring

    Time frame: 6minutes after intrathecal injection

  9. hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring

    Time frame: 8minutes after intrathecal injection

  10. hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring

    Time frame: 10minutes after intrathecal injection

  11. hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring

    Time frame: 15minutes after intrathecal injection

  12. hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring

    Time frame: 20minutes after intrathecal injection

Sponsors and collaborators

Lead sponsor

Qazvin University Of Medical Sciences

Other

Registry information

Official study title

The Effects of Intrathecal Magnesium and Fentanyl Added to Bupivacaine on Postoperative Analgesic Requirement in Patients Undergoing Lower Limb Orthopedic Surgery

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Sep 21, 2010
Registry last updated
Oct 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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