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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Post Operative Pain

Treatments: Other: General anesthesia using intravenous fentanyl (1µg/kg); Drug: Intrathecal morphine; Procedure: Ultrasound Guided Erector Spinae Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT05338320

FMASU MD 102/2022

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

General anesthesia and Ultrasound Guided Erector Spinae Plane Block

Active Comparator group

Treatment:

Procedure: Ultrasound Guided Erector Spinae Plane Block

General anesthesia and intrathecal morphine

Active Comparator group

Treatment:

Drug: Intrathecal morphine

General anesthesia using intravenous fentanyl (1µg/kg)

Other group

Treatment:

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