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

Phase 4

Completed

• Conditions: Post Operative Pain
• Interventions: Procedure: Ultrasound Guided Erector Spinae Plane Block; Drug: Intrathecal morphine; Other: General anesthesia using intravenous fentanyl (1µg/kg)

• Registration Number: NCT05338320
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-21
• Study Start: 2022-05-10
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Body mass index (BMI) 25 to 35 kg/m².
• American Society of Anesthesiologist (ASA) physical status I or II.

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Exclusion Criteria

• patient's refusal
• Altered mental status
• Known allergy to study drugs (bupivacaine or morphine)
• Local infection at site of puncture.
• Known case with any pulmonary disease
• Known case with Obstructive sleep apnea (OSA)
• Coagulopathy and /or thrombocytopenia
• Severe hepatic or kidney impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia and Ultrasound Guided Erector Spinae Plane Block	Ultrasound Guided Erector Spinae Plane Block	-
General anesthesia and intrathecal morphine	Intrathecal morphine	-
General anesthesia using intravenous fentanyl (1µg/kg)	General anesthesia using intravenous fentanyl (1µg/kg)	-

Primary Outcome Measures

Name	Time	Method
Time to first requested rescue analgesia (Minutes).	First 24 hours after surgery.	Time to first requested rescue analgesia (Minutes).

Trial Locations

Locations (1)

Ain-Shams University Hospitals; 🇪🇬 Cairo, Egypt