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
Overview
- Phase
- Phase 4
- Intervention
- Ultrasound Guided Erector Spinae Plane Block
- Conditions
- Post Operative Pain
- Sponsor
- Ain Shams University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Time to first requested rescue analgesia (Minutes).
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Ibrahim Mamdouh Esmat
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Ain Shams University
Eligibility Criteria
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
Arms & Interventions
General anesthesia and Ultrasound Guided Erector Spinae Plane Block
Intervention: Ultrasound Guided Erector Spinae Plane Block
General anesthesia and intrathecal morphine
Intervention: Intrathecal morphine
General anesthesia using intravenous fentanyl (1µg/kg)
Intervention: General anesthesia using intravenous fentanyl (1µg/kg)
Outcomes
Primary Outcomes
Time to first requested rescue analgesia (Minutes).
Time Frame: First 24 hours after surgery.
Time to first requested rescue analgesia (Minutes).