CClinicalTrials.gg
CompletedNCT05289401Updated Mar 21, 2022

Analgesic Effect of Ultrasound Guided Errector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Open Renal Surgeries.

An interventional study of ultrasound guided blocks in Analgesia , Open Renal Surgeries, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2022-03-21.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2021, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
2 Years to 6 Years
Sex
All
01

Study summary

comparison between the erector spinae block and caudal block with the aid of the of ultra sound in children as regard time of request of rescue analgesia , degree of intra and post operative pain relief , effect of hemodynamic stability and incidences of complication in open renal surgeries .

Read the detailed description

Open Renal surgeries (pyeloplasty and nephrectomy) is associated with significant postoperative pain. Adequate postoperative analgesia is important to allow for early mobilization and discharge of the patients .Systemic opioids are usually not sufficient for pain control after renal surgeries in children. The use of opioid in pediatrics has many side effects such as somnolence, vomiting, and up to respiratory depression.

Neuraxial analgesia is usually required in these operations in combination with general anesthesia. Neuraxial analgesia decreases morbidity, mortality, opiate exposure, shortens post anesthesia recovery room time and hospital stay. However, it is usually associated with many complications as urinary retention and excessive motor block.

Caudal block is the most commonly used neuraxial anesthesia in pediatric patients. It can be used for analgesia in different renal surgeries providing adequate pain relief in the post- operative period .

Paediatric regional anaesthesia (PRA) is one of the most valuable and safe tools to treat perioperative pain and is an essential part of modern anaesthetic practice. It offers many advantages to both the patient and the hospital. It provides excellent pain relief and allows caregivers to use multimodal analgesic techniques and decrease the use of opioids without the complications of neuraxial anesthesia. Considerable progress has been made in the practice of PRA over the past few years including availability of information on safety and incorporation of ultrasound guidance. Novel regional anaesthesia (RA) techniques, especially the anterolateral and the posterolateral trunk blocks, show promise .

The erector spinae plane block (ESPB), one of the posterolateral trunk blocks, was first described by Forero et al. in 2016 and has been used by many anaesthesiologists for perioperative pain relief 4. Its mechanism of action is spreading of local anesthetic into multiple paravertebral spaces after injection into the interfascial space between the transverse process of the vertebrae and the erector spinae muscle. It can be used for postoperative analgesia for longer period and decrease the use of opioids with less complications in several pediatric surgeries including nephrectomy and pyeloplasty.

For this reason, ESPB efficacy will be compared to the caudal block efficacy seeking for a simple, safe and effective regional analgesic technique for renal surgeries in children.

Electrical Cardiometry is a method for the non-invasive determination of stroke volume (SV), cardiac output (CO), stroke volume variation (SVV) and other hemodynamic parameters in adults, children, and neonates and it has been validated against "gold standard" methods such as thermodilution. Several potential mechanisms have been suggested for the action of the ESPB such as paravertebral spread as well as epidural spread of local anesthetic. These mechanisms raise the concern of the possible negative hemodynamic consequences of the ESPB which were not properly investigated .

02

Conditions studied

  • Analgesia , Open Renal Surgeries

Keywords

  • erector spinae block , caudal block
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
2 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients 2-6 years old.
  • American society of anesthesiologists classification (ASA) I and II .
  • Patients undergoing unilateral open renal surgeries.

Exclusion criteria

Exclusion Criteria:

  • Refusal of block.
  • Bleeding disorders (platelets count \< 150,000; INR >1.5; PC\< 60%).
  • Skin lesion, wounds or infection at the puncture site.
  • Known allergy to local anesthetic drugs.
  • Contraindications to neuraxial block as sepsis, severe aortic stenosis, increased intracranial pressure.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    ESPB

    Unilateral erector spinae block will be performed in the lateral position . 0.5 mL/Kg of bupivacaine 0.125% will be injected taking care not to exceed the maximum recommended dose (2 mg/kg of bupivacaine)

    Other: ultrasound guided blocks

  • Active comparator
    CB

    caudal block performed in lateral position . bolus of 1.2 ml/Kg bupivacaine 0.125% .

    Other: ultrasound guided blocks

Interventions

  • Otherultrasound guided blocks

    Ultrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric

06

What researchers measure

Primary outcomes

  1. primary outcome

    The first time to require rescue analgesia in minutes (from the time of erector spinae block or caudal injection to the first registration of CHEOPS pain score more than 6)

    Time frame: at the time of transfer from PACU and then at 1, 2, 3, 4, 6, 8 and 12 hours postoperatively

Secondary outcomes

  1. secondary outcome

    Total analgesia consumption in each group in the first 12 hours post-operative period

    Time frame: at time of transfer to PACU and then at 1, 2, 3, 4, 6, 8 and 12 hours.

07

Study locations

1 site
  • Cairo University
    Cairo, C 11211, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05289401
Lead sponsor
Cairo University
Responsible party
Chahenda Salem (M.Sc, Cairo University) — Principal investigator
First posted
Mar 21, 2022
Start date
Jan 1, 2021
Primary completion
Feb 1, 2022
Completion
Mar 1, 2022
Last update
Mar 21, 2022

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion