Lumbar Spine Disc HerniationPhase 4NCT01843296
Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Sensory-Motor Blocks and Postoperative Pain in Lumbar Disk Herniation Surgery
A Phase 4 study testing Magnesium Sulfate, Spinal Anesthesia and Bupivacaine in people with Lumbar Spine Disc Herniation, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to Compare three methods of intrathecal bupivacaine; bupivacaine-fentanyl; bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks and postoperative pain in patients undergoing lumbar disk herniation surgery. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spine Disc Herniation
- What is being tested?
- Magnesium Sulfate, Spinal Anesthesia and Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIran
- Study dates
- Nov 2012to Apr 2013
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Candidate for lumbar disk herniation surgery
- No contraindication to the spinal anesthesia
- No history of allergy to opioids and magnesium sulfate
- No peripheral or central neuropathies
- No previous history of surgery on same disk level
Who cannot join
- Patients with intraoperative tearing of dural suc
- Occuring of inadvertent intraoperative complications such as bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Three Methods of Intrathecal Bupivacaine; Bupivacaine-Fentanyl and Bupivacaine-Fentanyl-Magnesium Sulfate on Sensory-Motor Blocks and Postoperative Pain in Patients Undergoing Lumbar Disk Herniation Surgery
The purpose of this study is to Compare three methods of intrathecal bupivacaine; bupivacaine-fentanyl; bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks and postoperative pain in patients undergoing lumbar disk herniation surgery.
Read the detailed description
- Comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks in patients undergoing lumbar disk herniation surgery
- Comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on postoperative pain in patients undergoing lumbar disk herniation surgery
- Comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on postoperative side effects in patients undergoing lumbar disk herniation surgery
- Conditions
- Lumbar Spine Disc Herniation
- Being tested
- Magnesium Sulfate, Spinal Anesthesia, Bupivacaine, Fentanyl
- Keywords
- Spinal Anesthesia, Bupivacaine, Fentanyl, Magnesium sulfate, Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Also called Magnesium sulfate 50%
Injection of 50 mg of magnesium sulfate 50% (0.1 ml),intrathecally.
Spinal AnesthesiaProcedure or surgery
Lumbar puncture was performed in sitting position,at the one level above iliac crest. Using a median approach, a 25-G Quincke needle was introduced with the needle aperture directed laterally.
BupivacaineDrug
Also called Marcaine
FentanylDrug
Also called Sublimaze
| Study group | Role | What they receive |
|---|---|---|
| Magnesium | Active comparator | Patients in group C received a premixed solution of 15 mg hyperbaric bupivacaine 0.5% (3 ml) and 25 µg fentanyl (0.5cc) and 50 mg of magnesium sulfate 50% (0.1 ml) (Pasteur Institute Co, Tehran, Iran) for spinal anesthesia Receives: Drug: Magnesium Sulfate; Procedure: Spinal Anesthesia; Drug: Bupivacaine; Drug: Fentanyl |
| Fentanyl | Active comparator | Patients in Fentanyl group received a premixed solution of of 15 mg hyperbaric bupivacaine 0.5% (3 ml) and 25 µg fentanyl (0.5cc),plus 0.1 cc preservative free 0.9% normal saline for spinal anesthesia Receives: Procedure: Spinal Anesthesia; Drug: Bupivacaine; Drug: Fentanyl |
| Bupivacaine | Active comparator | Patients in Bupivacaine group(control) received a premixed solution of 15 mg of hyperbaric bupivacaine 0.5% (3 ml), plus 0.6 cc preservative free 0.9% normal saline for spinal anesthesia Receives: Procedure: Spinal Anesthesia; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The onset of sensory block
Comparing the onset of sensory blocks to T10 (10th thoracic dermatome) assessed by pinprick test.
Measured: From intrathecal injection until the onset of sensory block assessed up to 15 minutes
The complete motor block
Time to complete motor block after intrathecal injection as assess using a modified Bromage scale
Measured: From intrathecal injection until the onset of complete motor block assessed up to 15 minutes
The sensory block regression
The sensory block regression to (T10) dermatome
Measured: From intrathecal injection until the sensory block reression to (T10) assessed up to 6 hours
The full motor recovery
Full motor recovery was defined as zero on the Bromage scale.
Measured: From intrathecal injection until the full motor recovery assessed up to 6 hours
The Pain Score
Using VAS (Visual Analogue Score) system
Measured: The first 24 hours after spinal anesthesia
Time to first analgesic requirement
Time to first analgesic requirement was measured from the time of spinal injection to the first time at which the patient complained of pain in the postoperative period
Measured: During first 24 hours after spinal anesthesia
Secondary outcomes (2)
Mean Arterial Blood Pressure
To compare blood pressure alteration and hypotension between three groups
Measured: First hour after spinal anesthesia
Heart Rate
To compare heart rate variation and bradycardia between three groups
Measured: First hour after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine Disc HerniationStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fereidoun Mortazavi Najafabadi, MD, Isfahan University of Medical Sciences
- Investigators
- Mohammad Ali Attari, MD, Study chair, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843296
- Sponsor's protocol ID
- 392022
- Status last verified
- Jun 2013
- First submitted
- 24 Apr 2013
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Three Methods of Intrathecal Bupivacaine; Bupivacaine-Fentanyl and Bupivacaine-Fentanyl-Magnesium Sulfate on Sensory-Motor Blocks and Postoperative Pain in Patients Undergoing Lumbar Disk Herniation Surgery
- ClinicalTrials.gov ID
- NCT01843296
- Acronym / sponsor ID
- 392022
- Conditions
- Lumbar Spine Disc Herniation
- Keywords
- Spinal Anesthesia, Bupivacaine, Fentanyl, Magnesium sulfate, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Apr 2013 (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.
The purpose of this study is to Compare three methods of intrathecal bupivacaine; bupivacaine-fentanyl; bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks and postoperative pain in patients undergoing lumbar disk herniation surgery.
Detailed description
- Comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks in patients undergoing lumbar disk herniation surgery
- Comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on postoperative pain in patients undergoing lumbar disk herniation surgery
- Comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on postoperative side effects in patients undergoing lumbar disk herniation surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Active comparator | Drug: Magnesium Sulfate, Procedure: Spinal Anesthesia, Drug: Bupivacaine, Drug: FentanylPatients in group C received a premixed solution of 15 mg hyperbaric bupivacaine 0.5% (3 ml) and 25 µg fentanyl (0.5cc) and 50 mg of magnesium sulfate 50% (0.1 ml) (Pasteur Institute Co, Tehran, Iran) for spinal anesthesia |
| Fentanyl | Active comparator | Procedure: Spinal Anesthesia, Drug: Bupivacaine, Drug: FentanylPatients in Fentanyl group received a premixed solution of of 15 mg hyperbaric bupivacaine 0.5% (3 ml) and 25 µg fentanyl (0.5cc),plus 0.1 cc preservative free 0.9% normal saline for spinal anesthesia |
| Bupivacaine | Active comparator | Procedure: Spinal Anesthesia, Drug: BupivacainePatients in Bupivacaine group(control) received a premixed solution of 15 mg of hyperbaric bupivacaine 0.5% (3 ml), plus 0.6 cc preservative free 0.9% normal saline for spinal anesthesia |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Candidate for lumbar disk herniation surgery
- No contraindication to the spinal anesthesia
- No history of allergy to opioids and magnesium sulfate
- No peripheral or central neuropathies
- No previous history of surgery on same disk level
Key exclusion criteria (2 listed)
- Patients with intraoperative tearing of dural suc
- Occuring of inadvertent intraoperative complications such as bleeding
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 |
|---|---|---|
| Magnesium SulfateAlso: Magnesium sulfate 50%Injection of 50 mg of magnesium sulfate 50% (0.1 ml),intrathecally. | Drug | Magnesium |
| Spinal AnesthesiaLumbar puncture was performed in sitting position,at the one level above iliac crest. Using a median approach, a 25-G Quincke needle was introduced with the needle aperture directed laterally. | Procedure or surgery | Bupivacaine, Fentanyl, Magnesium |
| BupivacaineAlso: Marcaine | Drug | Bupivacaine, Fentanyl, Magnesium |
| FentanylAlso: Sublimaze | Drug | Fentanyl, Magnesium |
Primary outcome
The onset of sensory block
Time frame: From intrathecal injection until the onset of sensory block assessed up to 15 minutes
Comparing the onset of sensory blocks to T10 (10th thoracic dermatome) assessed by pinprick test.
The complete motor block
Time frame: From intrathecal injection until the onset of complete motor block assessed up to 15 minutes
Time to complete motor block after intrathecal injection as assess using a modified Bromage scale
The sensory block regression
Time frame: From intrathecal injection until the sensory block reression to (T10) assessed up to 6 hours
The sensory block regression to (T10) dermatome
The full motor recovery
Time frame: From intrathecal injection until the full motor recovery assessed up to 6 hours
Full motor recovery was defined as zero on the Bromage scale.
The Pain Score
Time frame: The first 24 hours after spinal anesthesia
Using VAS (Visual Analogue Score) system
Time to first analgesic requirement
Time frame: During first 24 hours after spinal anesthesia
Time to first analgesic requirement was measured from the time of spinal injection to the first time at which the patient complained of pain in the postoperative period
2 secondary outcomes
Mean Arterial Blood Pressure
Time frame: First hour after spinal anesthesia
Heart Rate
Time frame: First hour after spinal anesthesia
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 2 Jul 2013.
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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.
Mohammad Ali Attari, MD study chair
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium Sulfate, Spinal Anesthesia and Bupivacaine in people with Lumbar Spine Disc Herniation, run by Isfahan 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 5 inclusion and 2 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 2 Jul 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The onset of sensory block (time frame: From intrathecal injection until the onset of sensory block assessed up to 15 minutes). The study lists 6 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 2 Jul 2013.