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

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

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: Group (B)

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:

1. -Contraindications for regional blocks (eg. Patient refusal Infection at the injection site, coagulopathy)
2. allergic reaction to drugs.
3. Patients with a history of liver, renal, heart and vascular failure, cardiac conduction disturbance.
4. 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)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt
    • Recruiting
    • Banī Suwayf, Egypt, 11391

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (B); will receive The bilateral ESP blocks before surgery	Other: Group (B); 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
Active Comparator: Group B MG; will receive bilateral ESP blocks performed by each side) before surgery	Other: Group (B); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to first request of analgesics in hours	time to first request of analgesics by the pateint in hours	change from base line for 24 hours

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 18, 2020
• Primary Completion (Anticipated): December 10, 2020
• Study Completion (Anticipated): December 10, 2020

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 14, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: FMBSUREC/07062020/Abd El Badei

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No