Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Sensory-Motor Blocks and Postoperative Pain in Lumbar Disk Herniation Surgery

Phase 4

Completed

• Conditions: Lumbar Spine Disc Herniation
• Interventions: Drug: Magnesium Sulfate; Procedure: Spinal Anesthesia; Drug: Bupivacaine; Drug: Fentanyl

• Registration Number: NCT01843296
• Lead Sponsor: Isfahan University of Medical Sciences

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

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2012-12
• Study Completion: 2013-04
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-04-30
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-30
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium	Spinal Anesthesia	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
Fentanyl	Spinal Anesthesia	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
Bupivacaine	Spinal Anesthesia	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
Magnesium	Magnesium Sulfate	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
Magnesium	Bupivacaine	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
Fentanyl	Bupivacaine	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
Magnesium	Fentanyl	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
Fentanyl	Fentanyl	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
Bupivacaine	Bupivacaine	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

Primary Outcome Measures

Name	Time	Method
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
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 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
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

Secondary Outcome Measures

Name	Time	Method
Mean Arterial Blood Pressure	First hour after spinal anesthesia	To compare blood pressure alteration and hypotension between three groups
Heart Rate	First hour after spinal anesthesia	To compare heart rate variation and bradycardia between three groups

Trial Locations

Locations (1)

Alzahra; 🇮🇷 Isfahan, Iran, Islamic Republic of