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

Lumbar Spine Disc Herniation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843296
• Other study ID #: 392022
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2013
• Last updated: June 30, 2013
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Spine Disc Herniation
• Pain, Postoperative

Intervention

Drug:
• Magnesium Sulfate
Injection of 50 mg of magnesium sulfate 50% (0.1 ml),intrathecally.

Procedure:
• Spinal 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.

Drug:
• Bupivacaine

• Fentanyl

Locations

Country	Name	City	State
Iran, Islamic Republic of	Alzahra	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	The Pain Score	Using VAS (Visual Analogue Score) system	The first 24 hours after spinal anesthesia	Yes
Primary	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	Yes
Secondary	Mean Arterial Blood Pressure	To compare blood pressure alteration and hypotension between three groups	First hour after spinal anesthesia	Yes
Secondary	Heart Rate	To compare heart rate variation and bradycardia between three groups	First hour after spinal anesthesia	Yes