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Status unknownNCT05247021ESBUpdated Feb 18, 2022

Erector Spinae Plane Block in Spine Surgeries

A Phase 4 interventional study of erector spinae block for group E in Lumbar Disc Disease, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-02-18.

Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jan 2021, registered Jan 2022).
Phase
Phase 4
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

Aim of this study was to assess the efficacy of erector spinae plane block (ESB) for postoperative pain management in lumbar spine surgery.

02

Conditions studied

  • Lumbar Disc Disease

Keywords

  • erector spinae block
  • Lumbar disc surgery
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients American Society of Anesthesiologists physical status (ASA) I and II.
  • Both sexes.
  • Age between 20 to 60 years old.
  • Scheduled for lumbar spine surgeries.

Exclusion criteria

Exclusion Criteria:

  • Patients who received long acting opioids preoperatively.
  • Patients with bleeding disorders and coagulopathy.
  • Infection at the injection site.
  • Allergy to local anesthetics.
  • Patients with significant cognitive dysfunction.
  • Patients with diabetic neuropathy.
  • Patients with uncontrolled hypertension or diabetes.
  • Patients with advanced cardiac, respiratory, hepatic or renal disease.
  • Patients with viral hepatitis or HIV.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    erector spinae block group (E)

    patients will receive bilateral ultrasound guided erector spinae block before the lumbar spine surgery starts.(20ml of bupivacaine 0.25%) after receiving general anesthesia

    Procedure: erector spinae block for group E

  • No intervention
    control group (C)

    patients will receive standard general anesthesia for lumbar spine surgery according to hospital protocol.

Interventions

  • Procedureerector spinae block for group E

    . The patient will be placed in the prone position. A high-frequency linear probe or a curved array probe, depending on the BMI of the patient, will be placed in longitudinal alignment, 2-3cm lateral to the vertebral column. The transverse processes of the vertebrae at the level of surgery, the erector spinae muscle, and the psoas muscle will be identified. A 5- or 8-cm 22-G ultrasound needle will be inserted with an in-plane technique in a cephalad-to-caudal direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, 20ml of bupivacaine 0.25% will be injected behind the erector spinae muscle. The same procedure will be repeated on the contralateral side.

06

What researchers measure

Primary outcomes

  1. the postoperative 24 hours morphine consumption

    the analgesic effect of erector spine block will be assessed postoperative by numeric rating scale (NRS), if NRS is more than 3 the patient will receive a rescue dose of 5 milligrams of morphine

    Time frame: 24 hours postoperative

Secondary outcomes

  1. Mean Blood pressure in mmHg

    Measure mean blood pressure of patients postoperative every 4 hours

    Time frame: 24 hours postoperative

  2. Heart rate

    Measure heart of the patients postoperative every 4 hours

    Time frame: 24 hours postoperative

  3. Patient satisfaction

    Measure patient satisfaction by asking the patient if he is satisfied or not " yes or no"

    Time frame: 24 hours postoperative

  4. First time of mobilization to a chair

    Measure the time to first mobilization to a chair in minutes

    Time frame: 24 hours postoperative

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603. PubMed 31033625 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05247021
Lead sponsor
Ain Shams University
Responsible party
Sponsor
First posted
Feb 18, 2022
Start date
Jan 22, 2021
Primary completion
Apr 22, 2022 (estimated)
Completion
Jun 2022 (estimated)
Last update
Feb 18, 2022

Study contacts

amgad A hamdi, MSc
Contact
amgadhamdi@med.asu.edu.eg
01002400389 ext. +2
ossama mansour, professor
study chair · faculty of medicine , ain shams university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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