Post Operative PainPhase 1/2NCT01205997
Comparison of Postoperative Analgesic Effect of Intrathecal Magnesium and Fentanyl Added to Bupivacaine in Patients Undergoing Lower Limb Orthopedic Surgery
A Phase 1/2 study testing Fentanyl and magnesium sulphate in people with Post Operative Pain, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Fentanyl and magnesium sulphate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Aug 2010to Jan 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- .patients with American Society of Anesthesiologists(ASA) physical status I and
- II, undergoing elective femur surgery
- -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Qazvin university of medical science
Qazvin, Qazvin Province, 34197/59811
About this study
Official title: The Effects of Intrathecal Magnesium and Fentanyl Added to Bupivacaine on Postoperative Analgesic Requirement 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 .
- Conditions
- Post Operative Pain
- Being tested
- Fentanyl, placebo(distilled water), magnesium sulphate
- Keywords
- magnesium, fentanyl, intrathecal, pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
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 sulphateDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| fentanyl | Active comparator | 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) Receives: Drug: Fentanyl |
| placebo | Placebo comparator | 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) Receives: Drug: placebo(distilled water) |
| magnesium sulphate | Active comparator | 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) Receives: Drug: magnesium sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first requirement of analgesic supplement
analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
Measured: 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)
Measured: 12 hours postoperative
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: every 5 minuts following intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 5min before the intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 2minutes after intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 4minutes after intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 6minutes after intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 8minutes after intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 10minutes after intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 15minutes after intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Measured: 20minutes after intrathecal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marzieh beigom khezri, Qazvin University Of Medical Sciences
- Investigators
- Marzieh Beigom Khezri, assistant professor, Principal investigator, Qazvin medical science university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205997
- Sponsor's protocol ID
- ACTRN12610000757011
- Status last verified
- Oct 2012
- First submitted
- 20 Sep 2010
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intrathecal Magnesium and Fentanyl Added to Bupivacaine on Postoperative Analgesic Requirement in Patients Undergoing Lower Limb Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT01205997
- Acronym / sponsor ID
- ACTRN12610000757011
- Conditions
- Post Operative Pain
- Keywords
- magnesium, fentanyl, intrathecal, pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 21 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fentanyl | Active comparator | Drug: FentanylNinety 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 | Placebo comparator | 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) |
| magnesium sulphate | Active comparator | Drug: magnesium sulphateNinety 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) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- .patients with American Society of Anesthesiologists(ASA) physical status I and
- II, undergoing elective femur surgery
- -
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylNinety 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(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) | Drug | placebo |
| magnesium sulphateNinety 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 |
Primary outcome
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)
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)
12 secondary outcomes
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
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 onset of motor block will be assessed by the modified Bromage score
Time frame: every10 seconds following intrathecal injection
duration of motor block will be assessed by the modified Bromage score
Time frame: every 5 minuts following intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 5min before the intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 2minutes after intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 4minutes after intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 6minutes after intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 8minutes after intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 10minutes after intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 15minutes after intrathecal injection
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
Time frame: 20minutes after intrathecal injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marzieh Beigom Khezri, assistant professor principal investigator
Qazvin medical science university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fentanyl and magnesium sulphate in people with Post Operative Pain, run by Qazvin University Of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first requirement of analgesic supplement (time frame: time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2012.