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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05338320

Enrollment

120

Registered

2022-04-21

Start date

2022-05-10

Completion date

2024-09-30

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

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.

Interventions

PROCEDUREUltrasound Guided Erector Spinae Plane Block

General anesthesia and Ultrasound Guided Erector Spinae Plane Block

DRUGIntrathecal morphine

General anesthesia and intrathecal morphine

OTHERGeneral anesthesia using intravenous fentanyl (1µg/kg)

General anesthesia using intravenous fentanyl (1µg/kg)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Time to first requested rescue analgesia (Minutes).	First 24 hours after surgery.	Time to first requested rescue analgesia (Minutes).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026