NCT05338320

Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia

A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia: Ultrasound Guided Erector Spinae Plane Block Versus Intrathecal Morphine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

It was proven that intrathecal opioids are considered as an effective means of pain control in several major surgical interventions including spine surgeries. Intrathecal morphine added to a spinal anesthesia reduces acute pain after spine surgeries but has side effects, including dose dependent respiratory depression, nausea, vomiting, pruritus, and sedation. Ultrasound guided Erector Spinae Plane Block (ESPB) was first described in 2016.Recent case reports suggest a positive effect of ultrasound guided ESPB on pain for multiple indications including lumbar spine fusion and scoliosis surgery, with a very low risk of complications as there are no structures in close proximity at risk of needle injury.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
PROCEDURE	Ultrasound Guided Erector Spinae Plane Block	General anesthesia and Ultrasound Guided Erector Spinae Plane Block
DRUG	Intrathecal morphine	General anesthesia and intrathecal morphine
OTHER	General anesthesia using intravenous fentanyl (1µg/kg)	General anesthesia using intravenous fentanyl (1µg/kg)

Timeline

• Start date: 2022-05-10
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2022-04-21
• Last updated: 2024-10-15

Locations

1 site across 1 country: Egypt