Analgesia, PostoperativeNCT06752252
Ultrasound Guided Paravertebral Block Versus Erector Spinae Block for Postoperative Analgesia After Inguinal Hernia Repair in Pediatric Patients
A study testing ultrasound guided paravertebral block and Ultrasound guided erector spinae plane block in people with Analgesia, Postoperative, run by Zagazig University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Postoperative
- What is being tested?
- ultrasound guided paravertebral block and Ultrasound guided erector spinae plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 Dec 2024to 30 Dec 2025
- Phase
- Interventional
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 24 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Fatima Ahmed, MD contact
Egypt2 sites, 2 recruiting
- Recruiting
faculty of human medicine, Zagazig university hospitals
El Sharkia
Ahmed Hegab, MD, 01000089347 ext. 002
- Recruiting
Faculty of Human Medicine, Zagazig University
El Sharkia
Ahmed Hegab, MD, 01000089347 ext. 002, dinamaghraby@yahoo.com
FATIMAH MAHMOUD, MD, 01018951337 ext. 002
About this study
Official title: Ultrasound Guided Paravertebral Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Inguinal Hernia Repair in Pediatric Patients: a Randomized Clinical Trial
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.
Read the 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).
- Conditions
- Analgesia, Postoperative
- Being tested
- ultrasound guided paravertebral block, Ultrasound guided erector spinae plane block, control group C
- Keywords
- postoperative analgesia, ultrasound guided paravertebral block, ultrasound guided erector spinae plane block, inguinal hernia repair in pediatric
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided paravertebral blockProcedure or surgery
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 blockProcedure or surgery
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 CProcedure or surgery
will receive standard general anesthesia with pain management protocol without regional block.
| Study group | Role | What they receive |
|---|---|---|
| Group paravertebral (PVB) block | Active comparator | In the lateral decubitus and 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 Receives: Procedure: ultrasound guided paravertebral block |
| Group erector spinae plane (ESP) block | Active comparator | In the lateral decubitus position ,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 and the surgery will be started after 15 min Receives: Procedure: Ultrasound guided erector spinae plane block |
| Control group (group C) | Active comparator | will receive standard general anesthesia with pain management protocol without regional block. Pain management protocol for all patients will include IV paracetamol 15 mg/kg every 6 hrs. (max dose for children <50 kg is 60 mg/kg daily and if body weight ≥ 50 kg max dose is 4 gm daily) . Ibuprofen will be given as rescue analgesia 10 mg/kg IV if MOPS was > 3 at rest or after movement and can be repeated every 6 hrs not exceeding 400 mg/dose and max daily dose 40 mg/kg. Receives: Procedure: control group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total amount of rescue analgesia (Ibuprofen consumption)
The total consumption of rescue analgesia (Ibuprofen consumption) postoperative
Measured: for 24 hours postoperative
Secondary outcomes (5)
Pain intensity at rest (static) and after movement or coughing (dynamic)
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)
Measured: 0 minutes immediate postoperative ( on arrival to PACU), 30 minutes, 1hs, 2hs, 4hs, 8hs, 12 hrs and 24hs postoperatively
The time to first request of rescue analgesia (Ibuprofen)
the time from giving block till time of first request of ibuprofen when MOPS > 3 at rest or after movement
Measured: for 24 hours postoperative
The total number of patients requiring additional dose of intraoperative fentanyl.
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)
Measured: during operation period
To record the incidence of complications
To record the incidence of complications (hematoma, local anesthetic toxicity, pneumothorax, infection, hypotension, epidural or intrathecal spread)
Measured: 24 hours postoperative
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)
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start30 Dec 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Postoperative analgesia after inguinal hernia repair in pediatric by ultrasound guided paravertebral block or erector spinae block
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Abdelhameed Elsadek Salem, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752252
- Sponsor's protocol ID
- 866
- Status last verified
- Dec 2024
- First submitted
- 21 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No