NCT05247021

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 18, 2022

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

January 11, 2022

Last Update Submit

February 9, 2022

Conditions

Lumbar Disc Disease

Keywords

erector spinae blockLumbar disc surgery

Outcome Measures

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

    24 hours postoperative

Secondary Outcomes (4)

  • Mean Blood pressure in mmHg

    24 hours postoperative

  • Heart rate

    24 hours postoperative

  • Patient satisfaction

    24 hours postoperative

  • First time of mobilization to a chair

    24 hours postoperative

Study Arms (2)

erector spinae block group (E)

EXPERIMENTAL

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

control group (C)

NO INTERVENTION

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

Interventions

erector spinae block for group EPROCEDURE

. 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.

erector spinae block group (E)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31033625BACKGROUND

MeSH Terms

Conditions

Intervertebral disc disease

Study Officials

  • ossama mansour, professor

    faculty of medicine , ain shams university

    STUDY CHAIR

Central Study Contacts

amgad A hamdi, MSc

CONTACT

01002400389amgadhamdi@med.asu.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

February 18, 2022

Study Start

January 22, 2021

Primary Completion

April 22, 2022

Study Completion

June 1, 2022

Last Updated

February 18, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)