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

NCT01843296 | Completed Phase 4 DMC

• 1 other identifier: 392022
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spine Disc Herniation

Keywords

Spinal Anesthesia; Bupivacaine; Fentanyl; Magnesium sulfate; Postoperative Pain

Outcome Measures

Primary Outcomes (6)

• The onset of sensory block

  Comparing the onset of sensory blocks to T10 (10th thoracic dermatome) assessed by pinprick test.

  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

  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

  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.

  From intrathecal injection until the full motor recovery assessed up to 6 hours

• The Pain Score

  Using VAS (Visual Analogue Score) system

  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

  During first 24 hours after spinal anesthesia

Secondary Outcomes (2)

• Mean Arterial Blood Pressure

  First hour after spinal anesthesia

• Heart Rate

  First hour after spinal anesthesia

Study Arms (3)

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

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

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

Procedure: Spinal Anesthesia; Drug: Bupivacaine

Interventions

Magnesium Sulfate DRUG

Injection of 50 mg of magnesium sulfate 50% (0.1 ml),intrathecally.

Also known as: Magnesium sulfate 50%

Magnesium

Spinal Anesthesia PROCEDURE

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.

Bupivacaine; Fentanyl; Magnesium

Bupivacaine DRUG

Also known as: Marcaine

Bupivacaine; Fentanyl; Magnesium

Fentanyl DRUG

Also known as: Sublimaze

Fentanyl; Magnesium

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with intraoperative tearing of dural suc
• Occuring of inadvertent intraoperative complications such as bleeding

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Alzahra

Isfahan, Isfahan, Iran

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium Sulfate; Anesthesia, Spinal; Bupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohammad Ali Attari, MD

  Isfahan University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: fellowship of neuroanesthesia

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 30, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: July 2, 2013

Record last verified: 2013-06

Locations

IR (1)