Post Operative Pain After Pediatric Hip SurgeryNCT04336085
Comparison of Ultrasound Guided Caudal Block and Ultrasound Guided Pericapsular Nerve Group Block for Pediatric Hip Surgery
A study testing caudal block and pericapsular nerve group block in people with Post Operative Pain After Pediatric Hip Surgery, run by Tanta University at 1 site in Egypt.
Trial summary
Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Post Operative Pain After Pediatric Hip Surgery
- What is being tested?
- caudal block and pericapsular nerve group block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2020to 30 Nov 2025
- 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
- 1- American Society of Anaestheologists physical activity class I and II. 2-aged between 1 year to 6 years. 3- undergoing pediatric elective hip surgery.
Who cannot join
- 1-Children with severe systemic disease with American Society of Anaestheologists physical activity class III or IV.
- 2-children with previous neurological or spinal disorders. 3-coagulation disorder. 4-infection at the block injection site. 5-history of allergy to local anesthetics. 6-bilateral hip surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia. The reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization. Ultrasound guided caudal block has many advantages as it is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, epidural space and the distribution of the local anesthetic agent within the epidural space. So, the success rate of caudal block is increase .
Pericapsular nerve group (PENG) block has been recently recommended by Girón-Arango et al. for use as postoperative analgesia in hip surgeries (8) It is a new regional anesthesia method in the region between the anterior inferior iliac spine (AIIS) and ilio-pubic eminence
Read the detailed description
Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia. The reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization. (1,2) Single shot caudal block has been the widely used to provide intraoperative and postoperative analgesia especially in pediatric surgery below the umbilical level, by block the region between T10 and S5 dermatomes. (3,4) The success rate of classic caudal epidural anesthesia method in pediatric patients has been reported to be about 75%. (5) Because there are many anatomical variations have been reported for sacral hiatus and sacral cornua.
Ultrasound guided caudal block has many advantages as it is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, epidural space and the distribution of the local anesthetic agent within the epidural space. So, the success rate of caudal block is increase (6) However caudal block has adverse effects such as hypotension, postoperative nausea, vomiting, urinary retention, excessive motor block, and pruritus that limit the use of caudal block in children. (7) Regional anesthetic techniques seem to be a better choice for improving acute pain management in these patients, with fewer adverse effects. Pericapsular nerve group (PENG) block has been recently recommended by Girón-Arango et al. for use as postoperative analgesia in hip surgeries (8) It is a new regional anesthesia method in the region between the anterior inferior iliac spine (AIIS) and ilio-pubic eminence (IPE).
The anterior capsule is the most richly innervated section of the joint suggesting these nerves should be the main targets for hip analgesia. (9) To the best of our knowledge, there are no previously published data comparing the pericapsular nerve group (PENG) block with caudal block techniques.
- Being tested
- caudal block, pericapsular nerve group block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudal blockProcedure or surgery
Caudal block will be performed using ultrasound guidance, the sacral hiatus will be visualized at the level of the sacral cornus by employing the linear transducer of ultrasound machine the ultrasound transducer will be rotated to 90 degree to obtain longitudinal views of the sacrococcygeal ligament and sacral hiatus and will be subsequently placed between the two cornua. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament.
pericapsular nerve group blockProcedure or surgery
In PENG group, the patient will be placed in supine position. The ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be visualized using a linear ultrasound probe. A 22-gauge, 50-mm needle will be introduced in a lateral to medial fashion in an in-plane approach to place the tip of the needle in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, a total volume of 1 mL/kg local anesthetic solution will be injected.
| Study group | Role | What they receive |
|---|---|---|
| caudal group | Experimental | Caudal block using ultrasound guidance. the sacral hiatus will be visualized at the level of the sacral cornus by employing the linear transducer of ultrasound machine and the depth and gain will be adjusted for optimal visual quality.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. Receives: Procedure: caudal block |
| PENG group | Experimental | The ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be visualized using a linear ultrasound probe. the needle will be introduced in a lateral to medial fashion in an in-plane approach to place the tip of the needle in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Receives: Procedure: pericapsular nerve group block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total doses of postoperative analgesic requirement
Total doses of postoperative morphine analgesic requirement
Measured: postoperative first day
Secondary outcomes (2)
Evaluation of the pain scores
Evaluation of the pain scores by FLACC scale
Measured: postoperative first day
Time to first rescue analgesic demand after surgery
Measured: postoperative first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start15 Apr 2020
- Primary completion15 Apr 2024
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain After Pediatric 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tarek abdel hay mostafa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336085
- Sponsor's protocol ID
- pericapsular nerve group block
- Status last verified
- Aug 2026
- First submitted
- 3 Apr 2020
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Guided Caudal Block and Ultrasound Guided Pericapsular Nerve Group Block for Pediatric Hip Surgery
- ClinicalTrials.gov ID
- NCT04336085
- Acronym / sponsor ID
- pericapsular nerve group block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 7 Apr 2020 (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.
Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia. The reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization. Ultrasound guided caudal block has many advantages as it is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, epidural space and the distribution of the local anesthetic agent within the epidural space. So, the success rate of caudal block is increase .
Pericapsular nerve group (PENG) block has been recently recommended by Girón-Arango et al. for use as postoperative analgesia in hip surgeries (8) It is a new regional anesthesia method in the region between the anterior inferior iliac spine (AIIS) and ilio-pubic eminence
Detailed description
Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia. The reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization. (1,2) Single shot caudal block has been the widely used to provide intraoperative and postoperative analgesia especially in pediatric surgery below the umbilical level, by block the region between T10 and S5 dermatomes. (3,4) The success rate of classic caudal epidural anesthesia method in pediatric patients has been reported to be about 75%. (5) Because there are many anatomical variations have been reported for sacral hiatus and sacral cornua.
Ultrasound guided caudal block has many advantages as it is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, epidural space and the distribution of the local anesthetic agent within the epidural space. So, the success rate of caudal block is increase (6) However caudal block has adverse effects such as hypotension, postoperative nausea, vomiting, urinary retention, excessive motor block, and pruritus that limit the use of caudal block in children. (7) Regional anesthetic techniques seem to be a better choice for improving acute pain management in these patients, with fewer adverse effects. Pericapsular nerve group (PENG) block has been recently recommended by Girón-Arango et al. for use as postoperative analgesia in hip surgeries (8) It is a new regional anesthesia method in the region between the anterior inferior iliac spine (AIIS) and ilio-pubic eminence (IPE).
The anterior capsule is the most richly innervated section of the joint suggesting these nerves should be the main targets for hip analgesia. (9) To the best of our knowledge, there are no previously published data comparing the pericapsular nerve group (PENG) block with caudal block techniques.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| caudal group | Experimental | Procedure: caudal blockCaudal block using ultrasound guidance. the sacral hiatus will be visualized at the level of the sacral cornus by employing the linear transducer of ultrasound machine and the depth and gain will be adjusted for optimal visual quality.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. |
| PENG group | Experimental | Procedure: pericapsular nerve group blockThe ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be visualized using a linear ultrasound probe. the needle will be introduced in a lateral to medial fashion in an in-plane approach to place the tip of the needle in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1- American Society of Anaestheologists physical activity class I and II. 2-aged between 1 year to 6 years. 3- undergoing pediatric elective hip surgery.
Key exclusion criteria (2 listed)
- 1-Children with severe systemic disease with American Society of Anaestheologists physical activity class III or IV.
- 2-children with previous neurological or spinal disorders. 3-coagulation disorder. 4-infection at the block injection site. 5-history of allergy to local anesthetics. 6-bilateral hip surgery.
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 blockCaudal block will be performed using ultrasound guidance, the sacral hiatus will be visualized at the level of the sacral cornus by employing the linear transducer of ultrasound machine the ultrasound transducer will be rotated to 90 degree to obtain longitudinal views of the sacrococcygeal ligament and sacral hiatus and will be subsequently placed between the two cornua. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament. | Procedure or surgery | caudal group |
| pericapsular nerve group blockIn PENG group, the patient will be placed in supine position. The ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be visualized using a linear ultrasound probe. A 22-gauge, 50-mm needle will be introduced in a lateral to medial fashion in an in-plane approach to place the tip of the needle in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, a total volume of 1 mL/kg local anesthetic solution will be injected. | Procedure or surgery | PENG group |
Primary outcome
Total doses of postoperative analgesic requirement
Time frame: postoperative first day
Total doses of postoperative morphine analgesic requirement
2 secondary outcomes
Evaluation of the pain scores
Time frame: postoperative first day
Time to first rescue analgesic demand after surgery
Time frame: postoperative first day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and pericapsular nerve group block in people with Post Operative Pain After Pediatric Hip Surgery, 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 11 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total doses of postoperative analgesic requirement (time frame: postoperative first day). 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 11 Aug 2026.