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

Study Overview
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Brief Summary
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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 .

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

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Fentanyl
* Drug: placebo(distilled water)
* Drug: magnesium sulphate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fentanyl<br>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<br>* 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)<br>|
| Placebo Comparator: placebo<br>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)<br>* 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)<br>|
| Active Comparator: magnesium sulphate<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first requirement of analgesic supplement | analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4) | time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution | 
| postoperative analgesic requirements | 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) | 12 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory block onset time will be assessed by a pinprick test | 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 | sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection | 
| duration of sensory block will be assessed by a pinprick test | 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 | sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection | 
| the onset of motor block will be assessed by the modified Bromage score | The onset of motor block was defined as the time between the end of injection of the intrathecal anesthetic to Bromage block 1 | every10 seconds following intrathecal injection | 
| duration of motor block will be assessed by the modified Bromage score | duration of motor block was defined the time from intrathecal injection to Bromage score0 | every 5 minuts following intrathecal injection | 
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring |  | 5min before the intrathecal injection | 
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring |  | 2minutes after intrathecal injection | 
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring |  | 4minutes after intrathecal injection | 
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring |  | 6minutes after intrathecal injection | 
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring |  | 8minutes after intrathecal injection | 
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring |  | 10minutes after intrathecal injection | 
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring |  | 15minutes after intrathecal injection | 
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring |  | 20minutes after intrathecal injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnesium, fentanyl, intrathecal, pain