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Analgesic Efficacy of the Erector Spinae Plane Block Using Bupivacaine Versus Bupivacaine/Magnesium Sulphate in Patients Undergoing Lumbar Spine Surgery

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group (B)
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • orthopedic
  • neurological patients
  • undergoing posterior lumbar spine fusion
  • American Society of Anesthesiologists (ASA) physical status 1 or 2.

Exclusion Criteria:

  • Contraindications for regional blocks
  • allergic reaction to drugs.
  • Patients with a history of liver, renal, heart and vascular failure, cardiac conduction disturbance.
  • opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs and calcium channel blockers (CCB).

Sites / Locations

  • Banī Suwayf, Egypt, 11391Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group (B)

Group B MG

Arm Description

will receive The bilateral ESP blocks before surgery

will receive bilateral ESP blocks performed by each side) before surgery

Outcomes

Primary Outcome Measures

time to first request of analgesics in hours
time to first request of analgesics by the pateint in hours

Secondary Outcome Measures

Full Information

First Posted
June 11, 2020
Last Updated
July 16, 2020
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT04433624
Brief Title
Analgesic Efficacy of the Erector Spinae Plane Block Using Bupivacaine Versus Bupivacaine/Magnesium Sulphate in Patients Undergoing Lumbar Spine Surgery
Official Title
Analgesic Efficacy of the Erector Spinae Plane Block Using Bupivacaine Versus Bupivacaine/Magnesium Sulphate in Patients Undergoing Lumbar Spine Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 18, 2020 (Anticipated)
Primary Completion Date
December 10, 2020 (Anticipated)
Study Completion Date
December 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Introduction: Severe postoperative pain following spine surgery is a significant cause of morbidity, extended length of facility stay, and marked opioid usage The analgesic regime for postoperative pain usually includes paracetamol,NSAIDs and opioids. The opioid epidemic as well as the opioid side effects2 (sedation,respiratory depression, constipation, delayed patient mobilization) has led perioperative physicians to find a way of decreasing the use of opioids. Increasing the use of regional anesthesia is one of the measures to this end. Ultrasound-guided erector spinae plane block (ESP) is a-- popular, interfascial regional technique that was initially described for the management of thoracic neuropathic pain . As the erector spinae fascia extends from the nuchal fascia cranially to the sacrum caudally, local anesthetic agents extend through several levels, and the block can be effective over a large area The ESP block provides effective postoperative analgesic effect for 24 hours in patients undergoing lumbar spinal surgery Magnesium sulfate (MGS) is a noncompetitive antagonist of N-methyl, D-aspartate (NMDA) receptors with an analgesic effect and is essential for release of acetylcholine from the presynaptic terminals and, similar to calcium channel blockers (CCB), can prevent the entry of calcium into the cell It is suggested that magnesium has many important roles to play in nociception
Detailed Description
The aim of this study is to evaluate the efficacy of the Erector Spinae Plane Block using bupivacaine versus bupivacaine/magnesium sulphate in Patients Undergoing Lumbar Spine surgery Inclusion criteria: orthopedic and neurological patients undergoing posterior lumbar spine fusion [American Society of Anesthesiologists (ASA) physical status 1 or 2. Exclusion Criteria: -Contraindications for regional blocks (eg. Patient refusal Infection at the injection site, coagulopathy) allergic reaction to drugs. Patients with a history of liver, renal, heart and vascular failure, cardiac conduction disturbance. opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs and calcium channel blockers (CCB). The patients will be blinded to the study drugs and will be randomly assigned into two equal groups by opaque sealed envelope as follows: Group (B) (n=15): will receive The bilateral ESP blocks were performed by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the erector spinae muscle and the transverse processes of the lumbar vertebrae Group B MG (n=15): will receive bilateral ESP blocks performed by each side) and and 500 mg magnesium sulphate into the fascial plane between the deep surface of the erector spinae muscle and the transverse processes of the lumbar vertebrae for pain management after lumbar spinal surgery injecting 40 mL of 0.25% bupivacaine(20 mL into each side)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group (B)
Arm Type
Active Comparator
Arm Description
will receive The bilateral ESP blocks before surgery
Arm Title
Group B MG
Arm Type
Active Comparator
Arm Description
will receive bilateral ESP blocks performed by each side) before surgery
Intervention Type
Other
Intervention Name(s)
Group (B)
Intervention Description
Group (B) (n=15): will receive The bilateral ESP blocks were performed by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the erector spinae muscle and the transverse processes of the lumbar vertebrae
Primary Outcome Measure Information:
Title
time to first request of analgesics in hours
Description
time to first request of analgesics by the pateint in hours
Time Frame
change from base line for 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: orthopedic neurological patients undergoing posterior lumbar spine fusion American Society of Anesthesiologists (ASA) physical status 1 or 2. Exclusion Criteria: Contraindications for regional blocks allergic reaction to drugs. Patients with a history of liver, renal, heart and vascular failure, cardiac conduction disturbance. opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs and calcium channel blockers (CCB).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
doaa rashwan, md
Phone
00201011270763
Email
doaa_rashwan@hotmail.com
Facility Information:
Facility Name
Banī Suwayf, Egypt, 11391
City
Banī Suwayf
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doaa Rashwan, MD
Phone
01011270763
Email
doaa_rashwan@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Analgesic Efficacy of the Erector Spinae Plane Block Using Bupivacaine Versus Bupivacaine/Magnesium Sulphate in Patients Undergoing Lumbar Spine Surgery

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