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Completed

NCT Number: NCT01843296

Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Sensory-Motor Blocks and Postoperative Pain in 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.

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Key information

Conditions

Lumbar Spine Disc Herniation Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alzahra

Isfahan, Iran

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

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

Other names: Magnesium sulfate 50%

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

Drug

Other names: Marcaine

Fentanyl

Drug

Other names: Sublimaze

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. The Pain Score

    Time frame: The first 24 hours after spinal anesthesia

    Using VAS (Visual Analogue Score) system

  6. 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

Secondary outcomes

  1. Mean Arterial Blood Pressure

    Time frame: First hour after spinal anesthesia

    To compare blood pressure alteration and hypotension between three groups

  2. Heart Rate

    Time frame: First hour after spinal anesthesia

    To compare heart rate variation and bradycardia between three groups

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 30, 2013
Registry last updated
Jul 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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