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NCT Number: NCT06752252

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

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.

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Key information

Conditions

Analgesia, Postoperative Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

24 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Human Medicine, Zagazig University, El Sharkia, Egypt

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About this study

  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1 - Parents acceptance

  • Age: preschool and school age child (24 months-12 years old).
  • Sex: both sex (males or females).
  • Physical status: ASA 1& II.
  • 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)

  • Patients with known history of allergy to the study drugs (bupivacaine and lidocaine).
  • Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases.

Treatment and study plan

ultrasound guided paravertebral block

Procedure

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

Ultrasound guided Erector Spinae Plane block

Procedure

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

control group C

Procedure

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

Primary outcomes

  1. The total amount of rescue analgesia (Ibuprofen consumption)

    Time frame: for 24 hours postoperative

    The total consumption of rescue analgesia (Ibuprofen consumption) postoperative

Secondary outcomes

  1. Pain intensity at rest (static) and after movement or coughing (dynamic)

    Time frame: 0 minutes immediate postoperative ( on arrival to PACU), 30 minutes, 1hs, 2hs, 4hs, 8hs, 12 hrs and 24hs postoperatively

    by using 10 points Modified Objective Pain Score (MOPS)(0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10= sever pain)

  2. The time to first request of rescue analgesia (Ibuprofen)

    Time frame: for 24 hours postoperative

    the time from giving block till time of first request of ibuprofen when MOPS > 3 at rest or after movement

  3. The total number of patients requiring additional dose of intraoperative fentanyl.

    Time frame: during operation period

    Number 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)

  4. To record the incidence of complications

    Time frame: 24 hours postoperative

    To record the incidence of complications (hematoma, local anesthetic toxicity, pneumothorax, infection, hypotension, epidural or intrathecal spread)

  5. Over all parent's satisfaction

    Time frame: 24 hours postoperative

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Sadek Salem, MD

CONTACT

[email protected]

0109933513 ext. 002

Fatima Ahmed, MD

CONTACT

01018951337 ext. 002

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2024
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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