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

NCT04433624 | Unknown

• 1 other identifier: FMBSUREC/07062020/Abd El Badei
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group (B)

ACTIVE COMPARATOR

will receive The bilateral ESP blocks before surgery

Other: Group (B)

Group B MG

ACTIVE COMPARATOR

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

Other: Group (B)

Interventions

Group (B) OTHER

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); Group B MG

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Banī Suwayf, Egypt, 11391

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Population Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

doaa rashwan, md

CONTACT

00201011270763; doaa_rashwan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor Doaa Rashwan

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: July 18, 2020
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

EG (1)