Lumbar Spine Disc Herniation
Conditions
Keywords
Spinal Anesthesia, Bupivacaine, Fentanyl, Magnesium sulfate, Postoperative Pain
Brief 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.
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
Interventions
DRUGMagnesium Sulfate
Injection of 50 mg of magnesium sulfate 50% (0.1 ml),intrathecally.
PROCEDURESpinal Anesthesia
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.
DRUGBupivacaine
DRUGFentanyl
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Patients with intraoperative tearing of dural suc * Occuring of inadvertent intraoperative complications such as bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first analgesic requirement | 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 |
| The full motor recovery | 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 | The first 24 hours after spinal anesthesia | Using VAS (Visual Analogue Score) system |
| The onset of sensory block | 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 | 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 | From intrathecal injection until the sensory block reression to (T10) assessed up to 6 hours | The sensory block regression to (T10) dermatome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | First hour after spinal anesthesia | To compare heart rate variation and bradycardia between three groups |
| Mean Arterial Blood Pressure | First hour after spinal anesthesia | To compare blood pressure alteration and hypotension between three groups |
Countries
Iran
Outcome results
None listed