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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2024-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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General anesthesia and Ultrasound Guided Erector Spinae Plane Block

Group Type ACTIVE_COMPARATOR

Ultrasound Guided Erector Spinae Plane Block

Intervention Type PROCEDURE

General anesthesia and Ultrasound Guided Erector Spinae Plane Block

General anesthesia and intrathecal morphine

Group Type ACTIVE_COMPARATOR

Intrathecal morphine

Intervention Type DRUG

General anesthesia and intrathecal morphine

General anesthesia using intravenous fentanyl (1µg/kg)

Group Type OTHER

General anesthesia using intravenous fentanyl (1µg/kg)

Intervention Type OTHER

General anesthesia using intravenous fentanyl (1µg/kg)

Interventions

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Ultrasound Guided Erector Spinae Plane Block

General anesthesia and Ultrasound Guided Erector Spinae Plane Block

Intervention Type PROCEDURE

Intrathecal morphine

General anesthesia and intrathecal morphine

Intervention Type DRUG

General anesthesia using intravenous fentanyl (1µg/kg)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No