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

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Fentanyl
placebo(distilled water)
magnesium sulphate
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain focused on measuring magnesium, fentanyl, intrathecal, pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Qazvin university of medical science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

fentanyl

placebo

magnesium sulphate

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

Time to first requirement of analgesic supplement
analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
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)

Secondary Outcome Measures

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

Full Information

First Posted
September 20, 2010
Last Updated
October 10, 2012
Sponsor
Qazvin University Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01205997
Brief Title
Comparison of Postoperative Analgesic Effect of Intrathecal Magnesium and Fentanyl Added to Bupivacaine in Patients Undergoing Lower Limb Orthopedic Surgery
Official Title
The Effects of Intrathecal Magnesium and Fentanyl Added to Bupivacaine on Postoperative Analgesic Requirement in Patients Undergoing Lower Limb Orthopedic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
magnesium, fentanyl, intrathecal, pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fentanyl
Arm Type
Active Comparator
Arm Description
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 Title
placebo
Arm Type
Placebo Comparator
Arm Description
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 Title
magnesium sulphate
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
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 Type
Drug
Intervention Name(s)
placebo(distilled water)
Intervention Description
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 Type
Drug
Intervention Name(s)
magnesium sulphate
Intervention Description
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 Outcome Measure Information:
Title
Time to first requirement of analgesic supplement
Description
analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
Time Frame
time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution
Title
postoperative analgesic requirements
Description
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)
Time Frame
12 hours postoperative
Secondary Outcome Measure Information:
Title
Sensory block onset time will be assessed by a pinprick test
Description
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
Time Frame
sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection
Title
duration of sensory block will be assessed by a pinprick test
Description
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
Time Frame
sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection
Title
the onset of motor block will be assessed by the modified Bromage score
Description
The onset of motor block was defined as the time between the end of injection of the intrathecal anesthetic to Bromage block 1
Time Frame
every10 seconds following intrathecal injection
Title
duration of motor block will be assessed by the modified Bromage score
Description
duration of motor block was defined the time from intrathecal injection to Bromage score0
Time Frame
every 5 minuts following intrathecal injection
Title
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time Frame
5min before the intrathecal injection
Title
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time Frame
2minutes after intrathecal injection
Title
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time Frame
4minutes after intrathecal injection
Title
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time Frame
6minutes after intrathecal injection
Title
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time Frame
8minutes after intrathecal injection
Title
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time Frame
10minutes after intrathecal injection
Title
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time Frame
15minutes after intrathecal injection
Title
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time Frame
20minutes after intrathecal injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marzieh Beigom Khezri, assistant professor
Organizational Affiliation
Qazvin medical science university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qazvin university of medical science
City
Qazvin
ZIP/Postal Code
34197/59811
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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