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

NCT05338320 | Completed Phase 4

• 1 other identifier: FMASU MD 102/2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Time to first requested rescue analgesia (Minutes).

  Time to first requested rescue analgesia (Minutes).

  First 24 hours after surgery.

Study Arms (3)

General anesthesia and Ultrasound Guided Erector Spinae Plane Block

ACTIVE COMPARATOR

Procedure: Ultrasound Guided Erector Spinae Plane Block

General anesthesia and intrathecal morphine

ACTIVE COMPARATOR

Drug: Intrathecal morphine

General anesthesia using intravenous fentanyl (1µg/kg)

OTHER

Other: General anesthesia using intravenous fentanyl (1µg/kg)

Interventions

Ultrasound Guided Erector Spinae Plane Block PROCEDURE

General anesthesia and Ultrasound Guided Erector Spinae Plane Block

General anesthesia and Ultrasound Guided Erector Spinae Plane Block

Intrathecal morphine DRUG

General anesthesia and intrathecal morphine

General anesthesia and intrathecal morphine

General anesthesia using intravenous fentanyl (1µg/kg) OTHER

General anesthesia using intravenous fentanyl (1µg/kg)

General anesthesia using intravenous fentanyl (1µg/kg)

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 21, 2022
• Study Start: May 10, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

EG (1)