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Completed

NCT Number: NCT05338320

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

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.

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Key information

Conditions

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

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain-Shams University Hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Ultrasound guided Erector Spinae Plane block

Procedure

General anesthesia and Ultrasound Guided Erector Spinae Plane Block

Intrathecal morphine

Drug

General anesthesia and intrathecal morphine

General anesthesia using intravenous fentanyl (1µg/kg)

Other

General anesthesia using intravenous fentanyl (1µg/kg)

Primary outcomes

  1. Time to first requested rescue analgesia (Minutes).

    Time frame: First 24 hours after surgery.

    Time to first requested rescue analgesia (Minutes).

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2022
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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