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Trial registered on ANZCTR


Registration number
ACTRN12610000757011
Ethics application status
Approved
Date submitted
10/09/2010
Date registered
14/09/2010
Date last updated
15/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of intrathecal magnesium and fentanyl added to bupivacaine on postoperative analgesic requirement in Patients undergoing lower limb orthopedic surgery
Scientific title
Comparison of Postoperative Analgesic Effect of intrathecal magnesium and fentanyl added to bupivacaine in Patients undergoing lower limb orthopedic surgery
Secondary ID [1] 252655 0
nil
Universal Trial Number (UTN)
U1111-1116-8385
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-operative pain in
Patients undergoing lower limb orthopedic surgery
258149 0
Condition category
Condition code
Anaesthesiology 258327 258327 0 0
Anaesthetics
Surgery 258328 258328 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 code [1] 257164 0
Prevention
Intervention code [2] 257184 0
Treatment: Drugs
Comparator / control treatment
The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water
Control group
Placebo

Outcomes
Primary outcome [1] 259181 0
Time to first requirement of analgesic supplement(analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
Timepoint [1] 259181 0
time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution
Primary outcome [2] 259182 0
postoperative analgesic requirements will be assessed by verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain)
Timepoint [2] 259182 0
12 hours postoperative (Each administration was initiated by patient request( VRS>4)
Secondary outcome [1] 265531 0
Sensory block onset time will be assessed by a pinprick test
Timepoint [1] 265531 0
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
Secondary outcome [2] 265532 0
duration of sensory block will be assessed by a pinprick test
Timepoint [2] 265532 0
the time for regression of two segments from the maximum block height((sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection
Secondary outcome [3] 265533 0
the onset of motor block will be assessed by the modified Bromage score (0, no motor loss; 1, inability to flex the hip; 2, inability to flex the knee; and 3, inability to flex the ankle)
Timepoint [3] 265533 0
the time from intrathecal injection to Bromage1 block 1(motor block will be assessed by pinprick test every 10 seconds following intrathecal injection
Secondary outcome [4] 265534 0
duration of motor block (the time from intrathecal injection to Bromage score 0) will be assessed by the modified Bromage score (0, no motor loss; 1, inability to flex the hip; 2, inability to flex the knee; and 3, inability to flex the ankle)
Timepoint [4] 265534 0
the time from intrathecal injection to Bromage score 0(motor block will be assessed by the modified Bromage score every 5 minuts following intrathecal injection
Secondary outcome [5] 265572 0
systolic and diastolic blood pressure is assessed by nonivasive automatic blood pressure measurement
Timepoint [5] 265572 0
5min before the intrathecal injection,and at 2, 4, 6,8, 10, 15,20 min after the injection
Secondary outcome [6] 265573 0
heart rate is assessed by echocardiogram monitoring
Timepoint [6] 265573 0
5min before the intrathecal injection,and at 2, 4, 6,8, 10, 15,20 min after the injection

Eligibility
Key inclusion criteria
patients with American Society of Anesthesiologists(ASA) physical status I and

II, undergoing elective femur surgery
Minimum age
20 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 or a history of chronic pain.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment is decided and permission of the patient is obtained by two of the anesthesiologists during preoperative rounding,.This is a double blinded clinical trial, with blinding of both the patient and the administrating practitioner to the anaesthetic type. Allocation will be managed by a Resident external to the project. The blinding will occur through use of equal amounts of pretreatment drugs (3.5ml’s) Each syringe will be labeled A ,B,C according to its contents. . The drug syringes are handed over to anesthesiologists blinded to the patient allocation to carry out the spinal of anesthesia
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was based on computer-generated codes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2856 0
Iran, Islamic Republic Of
State/province [1] 2856 0
qazvin

Funding & Sponsors
Funding source category [1] 257627 0
Self funded/Unfunded
Name [1] 257627 0
Marzieh Khezri
Address [1] 257627 0
Marzieh Beigom Khezri, , Department of Anesthesiology ,Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country [1] 257627 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Qazvin Medical Science University
Address
Shahid bahonar,Ave3419759811 Qazvin ,Iran
postal code:34197/59811
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 256848 0
Hospital
Name [1] 256848 0
Rajaei Hospital
Address [1] 256848 0
Padegan street,Qazvin,Iran
postal code:3413996134
Country [1] 256848 0
Iran, Islamic Republic Of
Other collaborator category [1] 251492 0
Individual
Name [1] 251492 0
Mahsa Hajikhani
Address [1] 251492 0
Mahsa Hajikhani,Resident of Anesthesiology,Qazvin Medical Science University,shahid bahonar,Ave3419759811 Qazvin ,Iran
postal code:34197/59811,
Country [1] 251492 0
Iran, Islamic Republic Of
Other collaborator category [2] 251497 0
Individual
Name [2] 251497 0
Siamak Yaghobi
Address [2] 251497 0
Department of Anesthesiology,Qazvin Medical Science University,shahid bahonar,Ave3419759811 Qazvin ,Iran
postal code:34197/59811,
Country [2] 251497 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259644 0
Qazvin Medical University Science
Ethics committee address [1] 259644 0
shahid bahonar,Ave3419759811 Qazvin ,Iran
postal code:34197/59811
Ethics committee country [1] 259644 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 259644 0
20/05/2010
Approval date [1] 259644 0
29/07/2010
Ethics approval number [1] 259644 0
d/20/1747

Summary
Brief summary
Objective :Magnesium has been suggested that NMDA (N-methyl D-aspartate)receptor antagonists induce preemptive analgesia when administrated before tissue injury occurs, thus decreasing the subsequent sensation of pain.
Methods: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 .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31619 0
Address 31619 0
Country 31619 0
Phone 31619 0
Fax 31619 0
Email 31619 0
Contact person for public queries
Name 14866 0
Marzieh Beigom Khezri
Address 14866 0
Marzieh Beigom Khezri, , Department of Anesthesiology ,Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country 14866 0
Iran, Islamic Republic Of
Phone 14866 0
+98-912-3811009
Fax 14866 0
+98-281-2236378
Email 14866 0
mkhezri@qums.ac.ir
Contact person for scientific queries
Name 5794 0
Marzieh Beigom Khezri
Address 5794 0
Marzieh Beigom Khezri, , Department of Anesthesiology ,Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country 5794 0
Iran, Islamic Republic Of
Phone 5794 0
+98-912-3811009
Fax 5794 0
+98-281-2236378
Email 5794 0
mkhezri@qums.ac.ir

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary