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Erector Spinae Plane Block in Spine Surgeries (ESB)

Primary Purpose

Lumbar Disc Disease

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
erector spinae block for group E
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Disease focused on measuring erector spinae block, Lumbar disc surgery

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

erector spinae block group (E)

control group (C)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean Blood pressure in mmHg
Measure mean blood pressure of patients postoperative every 4 hours
Heart rate
Measure heart of the patients postoperative every 4 hours
Patient satisfaction
Measure patient satisfaction by asking the patient if he is satisfied or not " yes or no"
First time of mobilization to a chair
Measure the time to first mobilization to a chair in minutes

Full Information

First Posted
January 11, 2022
Last Updated
February 9, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05247021
Brief Title
Erector Spinae Plane Block in Spine Surgeries
Acronym
ESB
Official Title
Bilateral Ultrasound Guided Erector Spinae Plane Block for Postoperative Pain Management in Lumbar Spine Surgery ( a Controlled Study Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
April 22, 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Disease
Keywords
erector spinae block, Lumbar disc surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
erector spinae block group (E)
Arm Type
Experimental
Arm Description
patients will receive bilateral ultrasound guided erector spinae block before the lumbar spine surgery starts.(20ml of bupivacaine 0.25%) after receiving general anesthesia
Arm Title
control group (C)
Arm Type
No Intervention
Arm Description
patients will receive standard general anesthesia for lumbar spine surgery according to hospital protocol.
Intervention Type
Procedure
Intervention Name(s)
erector spinae block for group E
Intervention Description
. 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.
Primary Outcome Measure Information:
Title
the postoperative 24 hours morphine consumption
Description
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 Outcome Measure Information:
Title
Mean Blood pressure in mmHg
Description
Measure mean blood pressure of patients postoperative every 4 hours
Time Frame
24 hours postoperative
Title
Heart rate
Description
Measure heart of the patients postoperative every 4 hours
Time Frame
24 hours postoperative
Title
Patient satisfaction
Description
Measure patient satisfaction by asking the patient if he is satisfied or not " yes or no"
Time Frame
24 hours postoperative
Title
First time of mobilization to a chair
Description
Measure the time to first mobilization to a chair in minutes
Time Frame
24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amgad A hamdi, MSc
Phone
01002400389
Ext
+2
Email
amgadhamdi@med.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ossama mansour, professor
Organizational Affiliation
faculty of medicine , ain shams university
Official's Role
Study Chair
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
amgad A hamdi, MSc
Phone
01002400389
Ext
+2
Email
amgadhamdi@med.asu.edu.eg
First Name & Middle Initial & Last Name & Degree
amr g sayed, MD
Phone
01005013194
Ext
+2
Email
dramrgaber7@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31033625
Citation
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.
Results Reference
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Erector Spinae Plane Block in Spine Surgeries

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