Postoperative Pain in Paediatric Hip SurgeryNCT05981781
Ultrasound Guided Pericapsular Nerve Group Block Versus Ultrasound Guided Caudal Block for Postoperative Pain in Paediatric Hip Surgery
A study testing ultrasound guided peng block in paediatric hip surgery and ultrasound guided caudal epidural block in paediatric hip surgery in people with Postoperative Pain in Paediatric Hip Surgery and PENG Block, run by Alexandria University at 1 site in Egypt.
Trial summary
Aim of the study is to evaluate postoperative analgesic effect of ultrasound guided PENG block in comparison to ultrasound guided caudal epidural anaesthesia for hip surgeries in paediatrics Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Postoperative Pain in Paediatric Hip Surgery, PENG Block, Caudal Block
- What is being tested?
- ultrasound guided peng block in paediatric hip surgery and ultrasound guided caudal epidural block in paediatric hip surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2023to 31 Jul 2024
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- paediatric patients belonging to American society of anesthesiologists (ASA)class1 or 2, aged 2-8 years scheduled for hip surgery
Who cannot join
- parent refusal skin infection at site of injection bleeding disorder or receiving anticoagulants history of allergy or contraindicaion to local anaesthetics neurological disease as cerebral palsy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Alexandria, Alexandria, Egypt, 21111
About this study
Aim of the study is to evaluate postoperative analgesic effect of ultrasound guided PENG block in comparison to ultrasound guided caudal epidural anaesthesia for hip surgeries in paediatrics
Read the detailed description
Hip surgeries in paediatric patients such as open hip surgery for correction of developmental dysplasia of the hip (DDH) lead to extensive injuries and severe pain. Multimodal analgesia is required to provide intraoperative and postoperative analgesia and to prevent the undesirable side effects of opioids including sedation, nausea, vomiting and constipation.
Perioperative pain control is of paramount importance during paediatric hip surgery. Inadequate analgesia can contribute to patient and parental dissatisfaction, prolonged recovery, and increased length of hospital stay. As such, regional anaesthesia is advantageous in providing sufficient analgesia while reducing the adverse effects of opioids. The use of regional anaesthesia in the paediatric population has increased over the last decade as it offers several potential advantages in the provision of postoperative analgesia including a reduction in parenteral opioids, decreased exposure to general anaesthetic agents, and shortened hospital stay. Such techniques may be particularly valuable following painful orthopedic procedures including hip and femur surgery.
Neuraxial techniques (caudal and intrathecal), lumbar plexus blockade, and combined femoral nerve and fascia iliaca blockade have been shown in a myriad of paediatric studies to exhibit opioid-sparing effects and lower postoperative pain scores in patients who are suffering from hip pain.
Caudal block is a common technique used for perioperative pain relief in paediatric lower limb surgeries but despite the success of neuraxial blocks in decreasing postoperative pain scores in paediatric patients undergoing hip surgery, positioning requirements, bilateral sensory and motor blockade, and urinary retention limit their use.
Among peripheral nerve block techniques used for relieving pain associated with hip fracture, ultrasound-guided femoral nerve (FN) block, fascia iliaca compartment (FIC) block and 3-in-1 FN block are widely used. However, these techniques have often failed to provide adequate block of the obturator nerve (ON) and the accessory obturator nerve (AON).
The pericapsular nerve group (PENG) block is an ultrasound guided approach, first described by Girón-Arango et al.(11) in 2018 for the anaesthetizing the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. It is a plane block involving one injection, performed under ultrasound guidance, of a high volume of local anaesthetic into the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. It was suggested that the articular branches of ON were blocked successfully due to the proximity of the target area to the subpectineal plane.
PENG block has been initially used as an alternative regional anaesthetic technique for the management of acute pain after hip fracture , but its applications are expanding, suggesting a potential role for analgesia after elective hip surgery. Previous studies concluded that this technique could provide an effective blockade of the articular branches of FN, ON and AON, with a potential motor-sparing effect.
- Being tested
- ultrasound guided peng block in paediatric hip surgery, ultrasound guided caudal epidural block in paediatric hip surgery
- Keywords
- PENG block, caudal block, hip surgery, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided peng block in paediatric hip surgeryProcedure or surgery
On the supine position, under strict aseptic technique, a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed in the transverse plane along the anterior inferior iliac spine (AIIS) to identify the iliopsoas muscle, femoral artery, and femoral nerve. The probe will be then rotated, and aligned with the pubic ramus to visualize the AIIS, iliopubic eminence (IPE), femoral artery, psoas muscle, and the superior pubic ramus.
Under direct visualization, a needle will be advanced in-plane, lateral to medial between the psoas tendon and pubic ramus until the needle contacts the IPE. The needle will be slightly withdrawn, and following negative aspiration, 0.5 ml/kg of bupivacaine 0.25% will be injected.
ultrasound guided caudal epidural block in paediatric hip surgeryProcedure or surgery
On lateral decubitus position, under strict aseptic technique, the sacral hiatus will be visualized at the level of the sacral cornua by employing a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed transversely at the midline to obtain a transverse view of the two cornua, sacrococcygeal ligament, sacral bone, and sacral hiatus. At this level, the ultrasound transducer will be rotated to 90 degree to obtain longitudinal views of the sacrococcygeal ligament and sacral hiatus and subsequently placed between the two cornua. A needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament. (17) At this level, after confirming absence of blood or cerebrospinal fluid on aspiration, bupivacaine 0.25% (0.5 mL/kg) will be injected over 1 minute while observing an ultrasound longitudinal image.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided peng block in paediatric hip surgery | Active comparator | Patients will receive US-guided PENG block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia. Receives: Procedure: ultrasound guided peng block in paediatric hip surgery |
| ultrasound guided caudal epidural block in paediatric hip surgery | Active comparator | Patients will receive US-guided caudal block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia. Receives: Procedure: ultrasound guided caudal epidural block in paediatric hip surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption
compare between both groups as regard postoperative opioid consumption
Measured: 24 hours
Secondary outcomes (5)
postoperative analgesia
postoperative analgesia by using FLACC scale
Measured: 24 hours
duration of postoperative analgesia
Measured: 24 hours
heamodynamics
changes in heart rate
Measured: 24 hours
incidence of complications
hypotension, bradycardia, nausea, vomiting, urinary retention, and pruritis
Measured: 24 hours
parent satisfaction
Using a 5 point score (0= very dissatisfied, 1= dissatisfied, 2= neither satisfied nor dissatisfied, 3= satisfied, 4= very satisfied)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start15 May 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain in Paediatric Hip SurgeryStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Model description
- Double blinded randomized study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabab Saber, professor, Study director, Alexandria UniversityAly Mahmoud, lecturer, Study director, Alexandria UniversityAhmed Mansour, professor, Study director, Alexandria Universityyomna Said, MBBCH, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981781
- Sponsor's protocol ID
- 0107623
- Status last verified
- Apr 2023
- First submitted
- 10 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data results and statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Pericapsular Nerve Group Block Versus Ultrasound Guided Caudal Block for Postoperative Pain in Paediatric Hip Surgery
- ClinicalTrials.gov ID
- NCT05981781
- Acronym / sponsor ID
- 0107623
- Keywords
- PENG block, caudal block, hip surgery, postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 8 Aug 2023 (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.
Aim of the study is to evaluate postoperative analgesic effect of ultrasound guided PENG block in comparison to ultrasound guided caudal epidural anaesthesia for hip surgeries in paediatrics
Detailed description
Hip surgeries in paediatric patients such as open hip surgery for correction of developmental dysplasia of the hip (DDH) lead to extensive injuries and severe pain. Multimodal analgesia is required to provide intraoperative and postoperative analgesia and to prevent the undesirable side effects of opioids including sedation, nausea, vomiting and constipation.
Perioperative pain control is of paramount importance during paediatric hip surgery. Inadequate analgesia can contribute to patient and parental dissatisfaction, prolonged recovery, and increased length of hospital stay. As such, regional anaesthesia is advantageous in providing sufficient analgesia while reducing the adverse effects of opioids. The use of regional anaesthesia in the paediatric population has increased over the last decade as it offers several potential advantages in the provision of postoperative analgesia including a reduction in parenteral opioids, decreased exposure to general anaesthetic agents, and shortened hospital stay. Such techniques may be particularly valuable following painful orthopedic procedures including hip and femur surgery.
Neuraxial techniques (caudal and intrathecal), lumbar plexus blockade, and combined femoral nerve and fascia iliaca blockade have been shown in a myriad of paediatric studies to exhibit opioid-sparing effects and lower postoperative pain scores in patients who are suffering from hip pain.
Caudal block is a common technique used for perioperative pain relief in paediatric lower limb surgeries but despite the success of neuraxial blocks in decreasing postoperative pain scores in paediatric patients undergoing hip surgery, positioning requirements, bilateral sensory and motor blockade, and urinary retention limit their use.
Among peripheral nerve block techniques used for relieving pain associated with hip fracture, ultrasound-guided femoral nerve (FN) block, fascia iliaca compartment (FIC) block and 3-in-1 FN block are widely used. However, these techniques have often failed to provide adequate block of the obturator nerve (ON) and the accessory obturator nerve (AON).
The pericapsular nerve group (PENG) block is an ultrasound guided approach, first described by Girón-Arango et al.(11) in 2018 for the anaesthetizing the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. It is a plane block involving one injection, performed under ultrasound guidance, of a high volume of local anaesthetic into the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. It was suggested that the articular branches of ON were blocked successfully due to the proximity of the target area to the subpectineal plane.
PENG block has been initially used as an alternative regional anaesthetic technique for the management of acute pain after hip fracture , but its applications are expanding, suggesting a potential role for analgesia after elective hip surgery. Previous studies concluded that this technique could provide an effective blockade of the articular branches of FN, ON and AON, with a potential motor-sparing effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded randomized study
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided peng block in paediatric hip surgery | Active comparator | Procedure: ultrasound guided peng block in paediatric hip surgeryPatients will receive US-guided PENG block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia. |
| ultrasound guided caudal epidural block in paediatric hip surgery | Active comparator | Procedure: ultrasound guided caudal epidural block in paediatric hip surgeryPatients will receive US-guided caudal block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- paediatric patients belonging to American society of anesthesiologists (ASA)class1 or 2, aged 2-8 years scheduled for hip surgery
Key exclusion criteria (1 listed)
- parent refusal skin infection at site of injection bleeding disorder or receiving anticoagulants history of allergy or contraindicaion to local anaesthetics neurological disease as cerebral palsy
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 |
|---|---|---|
| ultrasound guided peng block in paediatric hip surgeryOn the supine position, under strict aseptic technique, a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed in the transverse plane along the anterior inferior iliac spine (AIIS) to identify the iliopsoas muscle, femoral artery, and femoral nerve. The probe will be then rotated, and aligned with the pubic ramus to visualize the AIIS, iliopubic eminence (IPE), femoral artery, psoas muscle, and the superior pubic ramus. Under direct visualization, a needle will be advanced in-plane, lateral to medial between the psoas tendon and pubic ramus until the needle contacts the IPE. The needle will be slightly withdrawn, and following negative aspiration, 0.5 ml/kg of bupivacaine 0.25% will be injected. | Procedure or surgery | ultrasound guided peng block in paediatric hip surgery |
| ultrasound guided caudal epidural block in paediatric hip surgeryOn lateral decubitus position, under strict aseptic technique, the sacral hiatus will be visualized at the level of the sacral cornua by employing a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed transversely at the midline to obtain a transverse view of the two cornua, sacrococcygeal ligament, sacral bone, and sacral hiatus. At this level, the ultrasound transducer will be rotated to 90 degree to obtain longitudinal views of the sacrococcygeal ligament and sacral hiatus and subsequently placed between the two cornua. A needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament. (17) At this level, after confirming absence of blood or cerebrospinal fluid on aspiration, bupivacaine 0.25% (0.5 mL/kg) will be injected over 1 minute while observing an ultrasound longitudinal image. | Procedure or surgery | ultrasound guided caudal epidural block in paediatric hip surgery |
Primary outcome
postoperative opioid consumption
Time frame: 24 hours
compare between both groups as regard postoperative opioid consumption
5 secondary outcomes
postoperative analgesia
Time frame: 24 hours
duration of postoperative analgesia
Time frame: 24 hours
heamodynamics
Time frame: 24 hours
incidence of complications
Time frame: 24 hours
parent satisfaction
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: Yes. Data results and statistical analysis
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.
Rabab Saber, professor study director
Alexandria University
Aly Mahmoud, lecturer study director
Alexandria University
Ahmed Mansour, professor study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided peng block in paediatric hip surgery and ultrasound guided caudal epidural block in paediatric hip surgery in people with Postoperative Pain in Paediatric Hip Surgery and PENG Block, run by Alexandria 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 1 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 8 Aug 2023. 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 Yomna Said, MBBCH (01065677956, yomna.said7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative opioid consumption (time frame: 24 hours). 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 8 Aug 2023.