Hip SurgeryNCT05460442
Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Pediatric Hip Surgery
A study testing Caudal Block group, Pericapsular nerve group block and Fascia iliaca group in people with Hip Surgery and Pericapsular Nerve, run by Tanta University at 1 site in Egypt.
Trial summary
This compares the postoperative analgesic effect of ultrasound-guided pericapsular nerve group block (PENG) with ultrasound-guided fascia iliaca compartment block in pediatric patients undergoing hip surgery. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Hip Surgery, Pericapsular Nerve, Fascia Iliaca
- What is being tested?
- Caudal Block group, Pericapsular nerve group block and Fascia iliaca group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2022to 29 Jul 2023
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients
- aged 1-6 years old
- both sexes,
- American Society of Anesthesiologists (ASA) physical activity class I-II
- scheduled for elective hip surgery under general anesthesia.
Who cannot join
- Children with the severe systemic disease with American Society of Anesthesiologists physical activity class III or IV.
- Children with previous neurological or spinal disorders.
- Coagulation disorder.
- Infection at the block injection site.
- History of allergy to local anesthetics.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University hospitals
Tanta
Ahmed Elsaied, M.B.B.CH, 1062612327 ext. +20, ahmed161971_pg@med.tanta.edu.eg
About this study
Official title: Comparison of Ultrasound-Guided Pericapsular Nerve Group Block Versus Ultrasound-Guided Fascia Iliaca Block for Pediatric Hip Surgery
This compares the postoperative analgesic effect of ultrasound-guided pericapsular nerve group block (PENG) with ultrasound-guided fascia iliaca compartment block in pediatric patients undergoing hip surgery.
Read the detailed description
Surgeries involving hip joints in pediatric patients are associated with severe intraoperative and postoperative pain despite the use of systemic opioids.
Caudal block is the most commonly used method of regional anesthesia in children to control intraoperative and postoperative pain in surgeries involving lower limbs. However, there have been many side effects of caudal block such as hypotension, urine retention, excessive motor block, technical failure, nausea, and vomiting which may limit its use.
There are several techniques of ultrasound-guided regional anesthesia that are used to control acute pain in hip surgery with fewer side effects such as a lumbar plexus block, femoral nerve block, or a fascia iliaca compartment block.
The fascia iliaca compartment block (FICB) was described in 1989. It remains a popular regional anesthetic technique for surgical procedures involving the hip joint and femur. Local anesthetic (LA) is injected proximally beneath the fascia iliaca to block the femoral nerve (FN), obturator nerve (ON), and lateral cutaneous nerve of the thigh (LCNT) simultaneously.
The pericapsular nerve group (PENG) block was introduced to block the articular branches of the femoral, obturator, and accessory obturator nerves which provide sensory innervation to the hip. This regional anesthetic technique was described in 2018 for acute analgesia related to hip fractures.
- Conditions
- Hip Surgery, Pericapsular Nerve, Fascia Iliaca
- Being tested
- Caudal Block group, Pericapsular nerve group block, Fascia iliaca group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal Block groupProcedure or surgery
Patients will be placed in the lateral decubitus position. After local sterilization with povidone-iodine, the sacral hiatus will be visualized at the level of the sacral Cornus by ultrasound. The needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament. At this level, after confirming the absence of blood or cerebrospinal fluid on aspiration, bupivacaine 0.25% (0.5 mL/kg) will be injected over 1 minute
Pericapsular nerve group blockProcedure or surgery
Patients will receive ultrasound-guided Pericapsular nerve group block in the supine position after proper sterilization of the groin region. The needle will be inserted in-plane with the transducer. The Pericapsular nerve group block group will receive 0.5 mL/kg of (0.25%) bupivacaine after a negative aspiration
Fascia iliaca groupProcedure or surgery
Patients will receive Ultrasound-Guided fascia iliaca compartment block in the supine position after sterilization of groin area. The needle will be inserted in-plane with the transducer. The needle tip will be advanced through the fascia iliaca and inserted further cephalad just below the fascia iliaca into the iliacus muscle. 0.5 mL/kg of (0.25%) bupivacaine will be injected and visualized moving cephalad away from the needle tip
| Study group | Role | What they receive |
|---|---|---|
| Caudal Block group | Experimental | 25 patients will receive ultrasound-guided caudal block with bupivacaine 0.25% (0.5 mL/kg) after induction of anesthesia. Receives: Procedure: Caudal Block group |
| Pericapsular nerve group block | Experimental | 25 patients will receive ipsilateral ultrasound-guided Pericapsular nerve group block with bupivacaine 0.25% (0.5 mL/kg) after induction of anesthesia. Receives: Procedure: Pericapsular nerve group block |
| Fascia iliaca group | Experimental | 25 patients will receive ipsilateral ultrasound-guided Fascia iliaca compartment block with bupivacaine 0.25% (0.5 m. L/kg) after induction of anesthesia. Receives: Procedure: Fascia iliaca group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioids consumption
Total Opioids consumption in first 24 hour postoperatively will be recorded
Measured: 24 hours postoperatively
Secondary outcomes (5)
Postoperative pain
Postoperative pain which will be assessed by face, legs, activity, and cry consolability scale [FLACC]
Measured: At post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours.
Time to first rescue analgesia
Time of administration of first rescue analgesia will be recorded.
Measured: 24 hours Postoperatively
Adverse effects
Adverse effects: hypotension, Bradycardia, hematoma, and local anesthetic toxicity will be observed and treated accordingly.
Measured: 24 hours Postoperatively
Heart rate
Perioperative heart rate will be observed
Measured: Intraoperative then at post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours
Mean arterial blood pressure
Perioperative mean arterial blood pressure will be observed
Measured: Intraoperative then at post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start15 Jul 2022
- Primary completion20 Jul 2023 (estimated)
- Study completion29 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip SurgeryStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsaied Mohamed Hosny Alam, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460442
- Sponsor's protocol ID
- 35436/4/22
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available under a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Pericapsular Nerve Group Block Versus Ultrasound-Guided Fascia Iliaca Block for Pediatric Hip Surgery
- ClinicalTrials.gov ID
- NCT05460442
- Acronym / sponsor ID
- 35436/4/22
- Conditions
- Hip Surgery, Pericapsular Nerve, Fascia Iliaca
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 29 Jul 2023 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This compares the postoperative analgesic effect of ultrasound-guided pericapsular nerve group block (PENG) with ultrasound-guided fascia iliaca compartment block in pediatric patients undergoing hip surgery.
Detailed description
Surgeries involving hip joints in pediatric patients are associated with severe intraoperative and postoperative pain despite the use of systemic opioids.
Caudal block is the most commonly used method of regional anesthesia in children to control intraoperative and postoperative pain in surgeries involving lower limbs. However, there have been many side effects of caudal block such as hypotension, urine retention, excessive motor block, technical failure, nausea, and vomiting which may limit its use.
There are several techniques of ultrasound-guided regional anesthesia that are used to control acute pain in hip surgery with fewer side effects such as a lumbar plexus block, femoral nerve block, or a fascia iliaca compartment block.
The fascia iliaca compartment block (FICB) was described in 1989. It remains a popular regional anesthetic technique for surgical procedures involving the hip joint and femur. Local anesthetic (LA) is injected proximally beneath the fascia iliaca to block the femoral nerve (FN), obturator nerve (ON), and lateral cutaneous nerve of the thigh (LCNT) simultaneously.
The pericapsular nerve group (PENG) block was introduced to block the articular branches of the femoral, obturator, and accessory obturator nerves which provide sensory innervation to the hip. This regional anesthetic technique was described in 2018 for acute analgesia related to hip fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caudal Block group | Experimental | Procedure: Caudal Block group25 patients will receive ultrasound-guided caudal block with bupivacaine 0.25% (0.5 mL/kg) after induction of anesthesia. |
| Pericapsular nerve group block | Experimental | Procedure: Pericapsular nerve group block25 patients will receive ipsilateral ultrasound-guided Pericapsular nerve group block with bupivacaine 0.25% (0.5 mL/kg) after induction of anesthesia. |
| Fascia iliaca group | Experimental | Procedure: Fascia iliaca group25 patients will receive ipsilateral ultrasound-guided Fascia iliaca compartment block with bupivacaine 0.25% (0.5 m. L/kg) after induction of anesthesia. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Pediatric patients
- aged 1-6 years old
- both sexes,
- American Society of Anesthesiologists (ASA) physical activity class I-II
- scheduled for elective hip surgery under general anesthesia.
Key exclusion criteria (5 listed)
- Children with the severe systemic disease with American Society of Anesthesiologists physical activity class III or IV.
- Children with previous neurological or spinal disorders.
- Coagulation disorder.
- Infection at the block injection site.
- History of allergy to local anesthetics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caudal Block groupPatients will be placed in the lateral decubitus position. After local sterilization with povidone-iodine, the sacral hiatus will be visualized at the level of the sacral Cornus by ultrasound. The needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament. At this level, after confirming the absence of blood or cerebrospinal fluid on aspiration, bupivacaine 0.25% (0.5 mL/kg) will be injected over 1 minute | Procedure or surgery | Caudal Block group |
| Pericapsular nerve group blockPatients will receive ultrasound-guided Pericapsular nerve group block in the supine position after proper sterilization of the groin region. The needle will be inserted in-plane with the transducer. The Pericapsular nerve group block group will receive 0.5 mL/kg of (0.25%) bupivacaine after a negative aspiration | Procedure or surgery | Pericapsular nerve group block |
| Fascia iliaca groupPatients will receive Ultrasound-Guided fascia iliaca compartment block in the supine position after sterilization of groin area. The needle will be inserted in-plane with the transducer. The needle tip will be advanced through the fascia iliaca and inserted further cephalad just below the fascia iliaca into the iliacus muscle. 0.5 mL/kg of (0.25%) bupivacaine will be injected and visualized moving cephalad away from the needle tip | Procedure or surgery | Fascia iliaca group |
Primary outcome
Total Opioids consumption
Time frame: 24 hours postoperatively
Total Opioids consumption in first 24 hour postoperatively will be recorded
5 secondary outcomes
Postoperative pain
Time frame: At post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours.
Time to first rescue analgesia
Time frame: 24 hours Postoperatively
Adverse effects
Time frame: 24 hours Postoperatively
Heart rate
Time frame: Intraoperative then at post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours
Mean arterial blood pressure
Time frame: Intraoperative then at post anesthesia care unit then after 30 minutes 2, 4, 6, 12, 24 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: Yes. The data will be available under a reasonable request from the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal Block group, Pericapsular nerve group block and Fascia iliaca group in people with Hip Surgery and Pericapsular Nerve, 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 5 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: status not confirmed, as of the sponsor's last update on 19 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Alam, M.B.B.CH (1062612327 ext. +20, ahmed161971_pg@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioids consumption (time frame: 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 Jul 2022.