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Ultrasound Guided Paravertebral Block Versus Erector Spinae Block for Postoperative Analgesia After Inguinal Hernia Repair in Pediatric Patients

Ultrasound Guided Paravertebral Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Inguinal Hernia Repair in Pediatric Patients: a Randomized Clinical Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06752252
Enrollment
158
Registered
2024-12-30
Start date
2024-12-30
Completion date
2025-12-30
Last updated
2025-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Postoperative

Keywords

postoperative analgesia, ultrasound guided paravertebral block, ultrasound guided erector spinae plane block, inguinal hernia repair in pediatric

Brief summary

The aim of the study is to compare postoperative analgesia in pediatric patients undergoing inguinal hernia repair by comparing the efficacy of ultrasound guided paravertebral block versus ultrasound guided erector spinae plane block.

Detailed description

* To assess the total amount of rescue analgesic consumption in the first 24 hours post-operatively in each group. * To measure the time of first request of rescue analgesia and to assess pain intensity at rest (static) and after movement or coughing (dynamic) using 10 points Modified Objective Pain Score (MOPS). * To record the incidence of complications (hematoma, local anesthetic toxicity, pneumothorax, infection, hypotension, epidural or intrathecal spread). * Over all parent's satisfaction: The parents will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

Interventions

after sterilization and identifying the level of T10 ,linear ultrasound probe will be placed in the midline over the spinous process at the chosen level, then the probe will be moved laterally to view the lamina and hyperechoic transverse process ,the pleural should be visible as a bright white line .The needle should be inserted in -plane from lateral to medial and the needle tip should end in a hypoechoic triangular space. Correct needle placement should be confirmed by anterior displacement of pleura with injection of small volume of saline then 0.5 ml/kg of a mixture of 0.25 ℅ bupivacaine and 1℅ lidocaine (1:1) will be injected

After sterilization, the linear ultrasound probe will be placed over transverse process of T10 ,after optimizing the image in sagittal or transverse scanning ,A 50 mm 22-G needle will be placed under the erector spinae muscle in -in plane orientation until it contacted T8 transverse process in the cranial caudal direction ,after hydro dissection and confirmation that the tip of the needle is between the transverse process and the fascia of the erector spinae muscle group, 0.5 ml/kg of a mixture of 0.25 ℅bupivacaine and 1℅ lidocaine (1:1) will be injected

will receive standard general anesthesia with pain management protocol without regional block.

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

anesthetist not sharing in the study will assess patients

Intervention model description

Postoperative analgesia after inguinal hernia repair in pediatric by ultrasound guided paravertebral block or erector spinae block

Eligibility

Sex/Gender
ALL
Age
24 Months to 12 Years
Healthy volunteers
Yes

Inclusion criteria

1 - Parents acceptance 2\. Age: preschool and school age child (24 months-12 years old). 3\. Sex: both sex (males or females). 4\. Physical status: ASA 1& II. 5\. Type of operation: elective unilateral inguinal hernia repair

Exclusion criteria

1- Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site) 2\. Patients with known history of allergy to the study drugs (bupivacaine and lidocaine). 3\. Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases.

Design outcomes

Primary

MeasureTime frameDescription
The total amount of rescue analgesia (Ibuprofen consumption)for 24 hours postoperativeThe total consumption of rescue analgesia (Ibuprofen consumption) postoperative

Secondary

MeasureTime frameDescription
Pain intensity at rest (static) and after movement or coughing (dynamic)0 minutes immediate postoperative ( on arrival to PACU), 30 minutes, 1hs, 2hs, 4hs, 8hs, 12 hrs and 24hs postoperativelyby using 10 points Modified Objective Pain Score (MOPS)(0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10= sever pain)
The time to first request of rescue analgesia (Ibuprofen)for 24 hours postoperativethe time from giving block till time of first request of ibuprofen when MOPS \> 3 at rest or after movement
The total number of patients requiring additional dose of intraoperative fentanyl.during operation periodNumber of patients receive additional dose of intra operative fentanyl ( increase in the mean blood pressure or heart rate 20% above base line readings, fentanyl in a dose 0.5 mcg/kg will be given to the patient)
To record the incidence of complications24 hours postoperativeTo record the incidence of complications (hematoma, local anesthetic toxicity, pneumothorax, infection, hypotension, epidural or intrathecal spread)
Over all parent's satisfaction24 hours postoperativeThe parents will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)

Countries

Egypt

Contacts

Primary ContactDina Sadek Salem, MD
dinamaghraby@yahoo.com0109933513
Backup ContactFatima Ahmed, MD
01018951337

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026