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

Sponsor

Qazvin University Of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01205997

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

17.9

Patients Per Site Per Month

Study Details

Study Description

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 .

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

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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

Placebo Comparator: placebo

Drug: placebo(distilled water)

Active Comparator: magnesium sulphate

Drug: magnesium sulphate

Outcome Measures

Primary Outcome Measures

Time to first requirement of analgesic supplement [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)
postoperative analgesic requirements [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 Outcome Measures

Sensory block onset time will be assessed by a pinprick test [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
duration of sensory block will be assessed by a pinprick test [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
the onset of motor block will be assessed by the modified Bromage score [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
duration of motor block will be assessed by the modified Bromage score [every 5 minuts following intrathecal injection]
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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.