Clinical trial NCT01843296: Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Sensory-Motor Blocks and Postoperative Pain in Lumbar Disk Herniation Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lumbar Spine Disc Herniation
Keywords: Spinal Anesthesia
Bupivacaine
Fentanyl
Magnesium sulfate
Postoperative Pain
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: The onset of sensory block
timeFrame: From intrathecal injection until the onset of sensory block assessed up to 15 minutes
measure: The complete motor block
timeFrame: From intrathecal injection until the onset of complete motor block assessed up to 15 minutes
measure: The sensory block regression
timeFrame: From intrathecal injection until the sensory block reression to (T10) assessed up to 6 hours
measure: The full motor recovery
timeFrame: From intrathecal injection until the full motor recovery assessed up to 6 hours
measure: The Pain Score
timeFrame: The first 24 hours after spinal anesthesia
measure: Time to first analgesic requirement
timeFrame: During first 24 hours after spinal anesthesia
Secondary outcomes:
measure: Mean Arterial Blood Pressure
timeFrame: First hour after spinal anesthesia
measure: Heart Rate
timeFrame: First hour after spinal anesthesia
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Alzahra
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Mohammad Ali Attari, MD
role: STUDY_CHAIR
References: