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Efficacy of Erector Spinae Plane Block in Lower Limb Surgery in PediatricNCT05369455

Erector Spinae Plane Block in Pediatric Lower Limb Surgery

A study testing erector spinae plane block and ultrasound guided caudal block in people with Efficacy of Erector Spinae Plane Block in Lower Limb Surgery in Pediatric, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Anesthesia will be induced in all patients using Fentanyl 1µg,propofol 2mg/kg and cisatracurium 0.15 mg/kg IV to facilitate endotracheal intubation, maintenance of anaesthesia afterward will be achieved by isoflurane1.5-2% in oxygen and air mixture, cisatracurium0.03 mg/kg. Read more about this study

Who is it for?
Ages 2 to 18 yearsHealthy volunteers can take part
What is being tested?
erector spinae plane block and ultrasound guided caudal block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
9 Dec 2021to 30 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • aged 2-15years old,
  • classified by the American society of anesthesiologists as ASA I and II
  • who will be scheduled for elective lower limb surgery will be enrolled in our study.

Who cannot join

  • Parents refusal,
  • spine or chest wall deformity,
  • coagulation disorders, ,
  • known respiratory and cardiac disorders, renal or hepatic insufficiency
  • known allergy to study drugs, uncooperative patients.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Tanta University Hospitals

    Tanta, 31511

Other trials in Egypt

About this study

Official title: Impact of Ultrasound Guided Erector Spine Plane & Caudal Block For Postoperative Analgesia In Pediatric Lower Limb Surgeries

Anesthesia will be induced in all patients using Fentanyl 1µg,propofol 2mg/kg and cisatracurium 0.15 mg/kg IV to facilitate endotracheal intubation, maintenance of anaesthesia afterward will be achieved by isoflurane1.5-2% in oxygen and air mixture, cisatracurium0.03 mg/kg.

In both groups , ultrasound guided block will be performed by an experienced anesthesiologist who has no subsequent role in the study after induction of anesthesia and before starting of surgery in lateral position, sterilized and covered with sterile sheets. Aseptic precautions is taken by wearing sterile gowns and gloves A sterile preparation of the ultrasound probe is obligatory. Outcome parameters will be assessed by another anesthesiologist blinded to the groups of assignment.

Read more

Group 1: group of ultrasound guided Erector spine plane block:

Group 11: group of ultrasound guided Cauda block:

Read the detailed description

Ethical considerations:

  • After approval from institutional ethics committee, an informed consent will be obtained from all parents of participants in this research. All data of patients will be confidential with secret codes and private file for each patient, and all given data will be used for the current medical research only.
  • Any unexpected risks appear during the course of the research will be cleared to the participants and ethical committee on time and proper measures will be taken to overcome or minimize these risks Patients will be randomized into two equal groups at a ratio of 1:1 to receive either Erector spine plane block (Group I n= 25) or Caudal block (Group II n= 25).

Randomization will be performed using sealed opaque envelopes indicating the group of assignment. A blinded nurse, who will not participate in the study or data collection, read the number contained in the envelope and made group assignments.

A preoperative evaluation in form of history taking, clinical examination and routine laboratory investigations, On arrival to the operating room, an intravenous (IV) cannula 24-22 gauge will be inserted and standard monitoring in terms of electrocardiogram (ECG), non-invasive blood pressure, capnograph and pulse oximeter for oxygen saturation (SpO2) will be connected to each participants. Patient received ,05mg midazolam and 4 mg ondansetron.

Anesthesia will be induced in all patients using Fentanyl 1µg,propofol 2mg/kg and cisatracurium 0.15 mg/kg IV to facilitate endotracheal intubation, maintenance of anaesthesia afterward will be achieved by isoflurane1.5-2% in oxygen and air mixture, cisatracurium0.03 mg/kg.

In both groups , ultrasound guided block will be performed by an experienced anesthesiologist who has no subsequent role in the study after induction of anesthesia and before starting of surgery in lateral position, sterilized and covered with sterile sheets. Aseptic precautions is taken by wearing sterile gowns and gloves A sterile preparation of the ultrasound probe is obligatory. Outcome parameters will be assessed by another anesthesiologist blinded to the groups of assignment.

Group 1: Technique of ultrasound guided Erector spine plane block:

The pa¬tient will be placed in in left lateral decubitus and the ultrasound-guided ESP block was performed at the(T12-L4) level on the left side.A 18_20 needle was inserted with the bevel in cephalo- caudal direction and 0.5 ml Kg of 0.25% Bupivacaine were injected Group 11: Technique of ultrasound guided Cauda block: With the patient in the left lateral decubitus position and the hips and knees flexed, the sacral hiatus can be identified using ultrasound First of all, the posterior superior iliac spines are palpated via anatomical landmarks, the line between both spines representing the base of an equilateral triangle the tip of which indicates the position of the sacral hiatus. The sacro coccygeal ligament can be palpated between the two sacral cornua, which is where the needle should penetrate the skin at an approximate 45 angle. Once the ligament has been passed, a flatter angle is adjusted by descending the needle before it can be advanced to the correct final position. Local anesthesia 0.5 ml Kg of 0.25% Bupivacaine were injected. Before application of local anesthetic , cautious aspiration or passive drainage is required to rule out an inadvertent intravascular or spinal needle location. Ultrasound guidance, by comparison ,offers two key advantages: it helps to identify small anatomical structures, and allows the spread of the local anesthetic to be seen by placing it longitudinally in a position slightly Para median to the lumbar spine .

Being tested
erector spinae plane block, ultrasound guided caudal block
Keywords
erector spinae -block-pediatric -lower limb

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erector spinae plane blockProcedure or surgery

    determine the efficacy and safety of ultra-sound guided erector spine plane block for providing postoperative analgesia in pediatric patients scheduled for lower limb surgeries as regard pain score , duration of analgesia and total postoperative analgesic requirement as a primary outcome as well as their safety as regard hemodynamics, adverse events local complications as secondary outcomes.

  • ultrasound guided caudal blockProcedure or surgery

    determine the efficacy and safety of ultra-sound guided caudal block for providing postoperative analgesia in pediatric patients scheduled for lower limb surgeries as regard pain score , duration of analgesia and total postoperative analgesic requirement as a primary outcome as well as their safety as regard hemodynamics, adverse events local complications as secondary outcomes.

Study groups in NCT05369455
Study groupRoleWhat they receive
group 1Experimentalgroup of ultrasound guided Erector spine plane block:
Receives: Procedure: erector spinae plane block
group 2Active comparatorgroup of ultrasound guided Caudal block:
Receives: Procedure: ultrasound guided caudal block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain score

    pain will be assessed using Face, Legs, Activity, Cry, and Consolability (FLACC) or Numeric Rating Scale (NRS) scores

    Measured: in first 24 hours postoperatively

Secondary outcomes (1)
  1. total postoperative analgesic requirement

    amount of postoperative analgesia (non steroidal )

    Measured: first 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2022
  2. Study start9 Dec 2021
  3. Primary completion10 May 2022
  4. Study completion30 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05369455
Sponsor's protocol ID
35040/11/21
Status last verified
Oct 2022
First submitted
23 Apr 2022
Last updated
19 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing erector spinae plane block and ultrasound guided caudal block in people with Efficacy of Erector Spinae Plane Block in Lower Limb Surgery in Pediatric, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain score (time frame: in first 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.

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