Pediatric Postoperative PainNCT05444309
Ultrasound Guided Pericapsular Nerve Group Block Versus Quadratus Lumborum Block
A study testing Quadratus lumborum (QL) block group and Pericapsular Nerve Group (PENG) block group in people with Pediatric Postoperative Pain, run by Zagazig University at 1 site in Egypt.
Trial summary
Hip surgeries in pediatrics consider as one of the common nowadays surgeries with sever postoperative pain so pain management is essential to decrease postoperative complications, early mobilization and hospital discharge. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Pediatric Postoperative Pain
- What is being tested?
- Quadratus lumborum (QL) block group and Pericapsular Nerve Group (PENG) block group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 10 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Physical status: ASA I-II
- Scheduled for open unilateral hip surgery
Who cannot join
- Parent's refusal
- Allergy to local anesthetics drugs
- Psychological, mental disorders or metabolic disease
- Patients with bleeding disorder, liver disease or sepsis
- Local infection or pervious surgery at site of anesthetic injection procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Pericapsular Nerve Group Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Pediatric Hip Surgeries
Hip surgeries in pediatrics consider as one of the common nowadays surgeries with sever postoperative pain so pain management is essential to decrease postoperative complications, early mobilization and hospital discharge. Traditional use of opioids is associated with many adverse effects such as sedation, dizziness, nausea, vomiting, constipation and respiratory depression.
Previous studies reported that Quadratus Lumborum (QL) Block and Pericapsular Nerve Group (PENG) Block are effective postoperative analgesia in hip surgeries.
In this study we will compare between QL block and PENG Block for effective postoperative analgesia to reduce opioids consumption and subsequently avoid opioid-related adverse effects, early mobilization and early hospital discharge.
Read the detailed description
Developmental dysplasia of the hip (DDH) is a common disease of the pediatrics patients with a rate of incidence 3 to 5 per 1000 children and open surgical reduction of congenital hip dislocation (CHD) is commonly done in paediatrics.
One of the most important challenges in pediatric hip surgeries is postoperative pain management which may result in impaired patient rehabilitation and prolonged hospitalizations.
Opioids are commonly used for postoperative analgesia in various surgeries but their use is associated with many complications such as sedation, dizziness, nausea, vomiting, constipation and respiratory depression. Many types of peripheral nerve blocks, such as the femoral nerve block (FNB) and the lumbar plexus block (LPB), are used for lower limb surgeries as well as anterior quadratus lumborum block (QLB) and Pericapsular nerve group (PENG) block that provide effective postoperative analgesia in lower limb surgeries.
Quadratus Lumborum (QL) block was first described by Rafael Blanco at the 2007 annual meeting of the European Society of Regional Anesthesia (ESRA). The basic concept of the QL block is the deposition of a local anesthetic solution adjacent to the anterolateral aspect of the QL muscle. The spread pattern obtained is similar to that of the landmark-based TAP block, in that there is subsequent extension into the thoracic paravertebral space. Borglum et al. originally described placing the needle tip anterior to the QL muscle using their transmuscular approach.
This technique was later refined by applying a posterior approach, named the "Shamrock method" (with the erector spinae, QL, and psoas muscles as the leaves and the L4 transverse process as the stem). Administering local anesthesia between the QL and psoas muscles ensures a reliable spread into the thoracic paravertebral space.
There are different quadratus lumborum blocks (anterior, posterior and lateral blocks) with different mechanisms of action according to injectate spread. However, there is insufficient evidence to recommend one approach and transducer positioning over another for individual patient populations and specific surgical types.
Pericapsular nerve group (PENG) block is relatively a recent regional technique based on blocking the articular branches to the hip joint with a single injection and is used for perioperative analgesia in hip surgery.
The pericapsular nerve group block (PENG) is a regional anesthetic technique described in 2018, developed primarily in total hip arthroplasties (THA) for postoperative analgesia with motor sparing benefits. The block is thought to provide more complete analgesia to the hip by depositing local anesthetic within the myofascial plane of the psoas muscle and superior pubic ramus.
- Conditions
- Pediatric Postoperative Pain
- Being tested
- Quadratus lumborum (QL) block group, Pericapsular Nerve Group (PENG) block group
- Keywords
- Pericapsular Nerve Group Block, Quadratus Lumborum Block, postoperative analgesia, pediatric hip surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum (QL) block groupProcedure or surgery
Also called Group Q
patient will receive 0.5 mg/kg of bupivacaine 0.25% through the quadratus lumborum block approach
Pericapsular Nerve Group (PENG) block groupProcedure or surgery
Also called Group P
patient will receive 0.5 mg/kg of bupivacaine 0.25% through the Pericapsular Nerve Group (PENG) block
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block group | Active comparator | The child will be positioned in the lateral position, with the operative side non-dependent. Under complete aseptic precautions, QL block will be given by anterior approach at the level of L4. A linear high-frequency probe of Sonosite M Turbo ultrasonography will be applied vertically above the iliac crest, and a 22G, 80 mm spinal needle will be inserted in the plane from the posterior edge of the probe through the QL muscle in an anteromedial direction. The needle tip will be placed between the Psoas major (PM) muscle and the QL muscle.
After negative aspiration, injection of 0.5 mL of normal saline to the space between PM and QL muscles .
An injection of 0.5 mg/kg of 0.25% bupivacaine into the fascial plane and the local anesthetic appears to press down the PM muscle in the ultrasound image, the patients will be repositioned to a supine position immediately after the block. Receives: Procedure: Quadratus lumborum (QL) block group |
| Pericapsular Nerve Group (PENG) block group | Active comparator | PENG block will be done while the child in supine position. Then, a high-frequency (8-15 MHz) ultrasound linear probe of Sonosite M Turbo ultrasonography (FUJIFILM Sonosite, Inc., Bothell, WA, USA) will be placed over the anterosuperior iliac spine and then rotating it 45 degrees to acquire images from lateral to medial of the anterior inferior iliac spine, iliopubic eminence, psoas tendon, and the femoral artery.
Then, a 22G, 80 mm spinal needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly.
After negative aspiration and a test does (0.5 mL of normal saline), an injection of 0.5 mg/kg of 0.25% bupivacaine into the space between the psoas tendon and the iliopubic eminence. Receives: Procedure: Pericapsular Nerve Group (PENG) block group |
| control group | No intervention | The child will not receive any block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of sensory block
It is the time from the end of block performance till the first patient's complain of pain
Measured: within 24 hour postoperative
Secondary outcomes (2)
Pain assessment
using Modified Objective Pain Scale (MOPS) a scale of 0-10, where 0= No pain and 10= Maximum worst pain.
Measured: immediately postoperative and then at 2, 4, 6, 12 & 24 hours after surgery
total amount of post-operative rescue analgesia needed
total amount of post-operative rescue analgesia in the form of ibuprofen syrup needed
Measured: in the first postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Aug 2022
- Primary completion1 May 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pediatric Postoperative PainStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- The patients will be divided randomly by a computer-generated randomization table into three equal groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rehab Abd-Allah Wahdan, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444309
- Sponsor's protocol ID
- 22-6-2022
- Status last verified
- Jul 2023
- First submitted
- 29 Jun 2022
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after the completion of the study and publication
Publications
Bialik V, Bialik GM, Blazer S, Sujov P, Wiener F, Berant M. Developmental dysplasia of the hip: a new approach to incidence. Pediatrics. 1999 Jan;103(1):93-9. doi: 10.1542/peds.103.1.93.
PubMed 9917445Gurkan Y, Aksu C, Kus A, Toker K, Solak M. One operator's experience of ultrasound guided lumbar plexus block for paediatric hip surgery. J Clin Monit Comput. 2017 Apr;31(2):331-336. doi: 10.1007/s10877-016-9869-x. Epub 2016 Mar 31.
PubMed 27033707Kikuchi M, Mihara T, Mizuno Y, Fujimoto H, Arai S, Nomura T, Goto T. Anterior quadratus lumborum block for postoperative recovery after total hip arthroplasty: a study protocol for a single-center, double-blind, randomized controlled trial. Trials. 2020 Feb 5;21(1):142. doi: 10.1186/s13063-020-4090-0.
PubMed 32024551Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
PubMed 28154824Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.
PubMed 30688787Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657Merella F, Canchi-Murali N, Mossetti V. General principles of regional anaesthesia in children. BJA Educ. 2019 Oct;19(10):342-348. doi: 10.1016/j.bjae.2019.06.003. Epub 2019 Aug 24. No abstract available.
PubMed 33456856Orozco S, Munoz D, Jaramillo S, Herrera AM. Pediatric use of Pericapsular Nerve Group (PENG) block for hip surgical procedures. J Clin Anesth. 2019 Nov;57:143-144. doi: 10.1016/j.jclinane.2019.04.010. Epub 2019 Apr 22. No abstract available.
PubMed 31022606
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Pericapsular Nerve Group Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Pediatric Hip Surgeries
- ClinicalTrials.gov ID
- NCT05444309
- Acronym / sponsor ID
- 22-6-2022
- Conditions
- Pediatric Postoperative Pain
- Keywords
- Pericapsular Nerve Group Block, Quadratus Lumborum Block, postoperative analgesia, pediatric hip surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 5 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.
Hip surgeries in pediatrics consider as one of the common nowadays surgeries with sever postoperative pain so pain management is essential to decrease postoperative complications, early mobilization and hospital discharge. Traditional use of opioids is associated with many adverse effects such as sedation, dizziness, nausea, vomiting, constipation and respiratory depression.
Previous studies reported that Quadratus Lumborum (QL) Block and Pericapsular Nerve Group (PENG) Block are effective postoperative analgesia in hip surgeries.
In this study we will compare between QL block and PENG Block for effective postoperative analgesia to reduce opioids consumption and subsequently avoid opioid-related adverse effects, early mobilization and early hospital discharge.
Detailed description
Developmental dysplasia of the hip (DDH) is a common disease of the pediatrics patients with a rate of incidence 3 to 5 per 1000 children and open surgical reduction of congenital hip dislocation (CHD) is commonly done in paediatrics.
One of the most important challenges in pediatric hip surgeries is postoperative pain management which may result in impaired patient rehabilitation and prolonged hospitalizations.
Opioids are commonly used for postoperative analgesia in various surgeries but their use is associated with many complications such as sedation, dizziness, nausea, vomiting, constipation and respiratory depression. Many types of peripheral nerve blocks, such as the femoral nerve block (FNB) and the lumbar plexus block (LPB), are used for lower limb surgeries as well as anterior quadratus lumborum block (QLB) and Pericapsular nerve group (PENG) block that provide effective postoperative analgesia in lower limb surgeries.
Quadratus Lumborum (QL) block was first described by Rafael Blanco at the 2007 annual meeting of the European Society of Regional Anesthesia (ESRA). The basic concept of the QL block is the deposition of a local anesthetic solution adjacent to the anterolateral aspect of the QL muscle. The spread pattern obtained is similar to that of the landmark-based TAP block, in that there is subsequent extension into the thoracic paravertebral space. Borglum et al. originally described placing the needle tip anterior to the QL muscle using their transmuscular approach.
This technique was later refined by applying a posterior approach, named the "Shamrock method" (with the erector spinae, QL, and psoas muscles as the leaves and the L4 transverse process as the stem). Administering local anesthesia between the QL and psoas muscles ensures a reliable spread into the thoracic paravertebral space.
There are different quadratus lumborum blocks (anterior, posterior and lateral blocks) with different mechanisms of action according to injectate spread. However, there is insufficient evidence to recommend one approach and transducer positioning over another for individual patient populations and specific surgical types.
Pericapsular nerve group (PENG) block is relatively a recent regional technique based on blocking the articular branches to the hip joint with a single injection and is used for perioperative analgesia in hip surgery.
The pericapsular nerve group block (PENG) is a regional anesthetic technique described in 2018, developed primarily in total hip arthroplasties (THA) for postoperative analgesia with motor sparing benefits. The block is thought to provide more complete analgesia to the hip by depositing local anesthetic within the myofascial plane of the psoas muscle and superior pubic ramus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- The patients will be divided randomly by a computer-generated randomization table into three equal groups
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum block group | Active comparator | Procedure: Quadratus lumborum (QL) block groupThe child will be positioned in the lateral position, with the operative side non-dependent. Under complete aseptic precautions, QL block will be given by anterior approach at the level of L4. A linear high-frequency probe of Sonosite M Turbo ultrasonography will be applied vertically above the iliac crest, and a 22G, 80 mm spinal needle will be inserted in the plane from the posterior edge of the probe through the QL muscle in an anteromedial direction. The needle tip will be placed between the Psoas major (PM) muscle and the QL muscle. After negative aspiration, injection of 0.5 mL of normal saline to the space between PM and QL muscles . An injection of 0.5 mg/kg of 0.25% bupivacaine into the fascial plane and the local anesthetic appears to press down the PM muscle in the ultrasound image, the patients will be repositioned to a supine position immediately after the block. |
| Pericapsular Nerve Group (PENG) block group | Active comparator | Procedure: Pericapsular Nerve Group (PENG) block groupPENG block will be done while the child in supine position. Then, a high-frequency (8-15 MHz) ultrasound linear probe of Sonosite M Turbo ultrasonography (FUJIFILM Sonosite, Inc., Bothell, WA, USA) will be placed over the anterosuperior iliac spine and then rotating it 45 degrees to acquire images from lateral to medial of the anterior inferior iliac spine, iliopubic eminence, psoas tendon, and the femoral artery. Then, a 22G, 80 mm spinal needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. After negative aspiration and a test does (0.5 mL of normal saline), an injection of 0.5 mg/kg of 0.25% bupivacaine into the space between the psoas tendon and the iliopubic eminence. |
| control group | No intervention | –The child will not receive any block. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Physical status: ASA I-II
- Scheduled for open unilateral hip surgery
Key exclusion criteria (5 listed)
- Parent's refusal
- Allergy to local anesthetics drugs
- Psychological, mental disorders or metabolic disease
- Patients with bleeding disorder, liver disease or sepsis
- Local infection or pervious surgery at site of anesthetic injection procedures.
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 |
|---|---|---|
| Quadratus lumborum (QL) block groupAlso: Group Qpatient will receive 0.5 mg/kg of bupivacaine 0.25% through the quadratus lumborum block approach | Procedure or surgery | Quadratus lumborum block group |
| Pericapsular Nerve Group (PENG) block groupAlso: Group Ppatient will receive 0.5 mg/kg of bupivacaine 0.25% through the Pericapsular Nerve Group (PENG) block | Procedure or surgery | Pericapsular Nerve Group (PENG) block group |
Primary outcome
duration of sensory block
Time frame: within 24 hour postoperative
It is the time from the end of block performance till the first patient's complain of pain
2 secondary outcomes
Pain assessment
Time frame: immediately postoperative and then at 2, 4, 6, 12 & 24 hours after surgery
total amount of post-operative rescue analgesia needed
Time frame: in the first postoperative 24 hours
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 14 Jul 2023.
- Background: PubMed 9917445Bialik V, Bialik GM, Blazer S, Sujov P, Wiener F, Berant M. Developmental dysplasia of the hip: a new approach to incidence. Pediatrics. 1999 Jan;103(1):93-9. doi: 10.1542/peds.103.1.93.
- Background: PubMed 27033707Gurkan Y, Aksu C, Kus A, Toker K, Solak M. One operator's experience of ultrasound guided lumbar plexus block for paediatric hip surgery. J Clin Monit Comput. 2017 Apr;31(2):331-336. doi: 10.1007/s10877-016-9869-x. Epub 2016 Mar 31.
- Background: PubMed 32024551Kikuchi M, Mihara T, Mizuno Y, Fujimoto H, Arai S, Nomura T, Goto T. Anterior quadratus lumborum block for postoperative recovery after total hip arthroplasty: a study protocol for a single-center, double-blind, randomized controlled trial. Trials. 2020 Feb 5;21(1):142. doi: 10.1186/s13063-020-4090-0.
- Background: PubMed 28154824Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
- Background: PubMed 30688787Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.
- Background: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Background: PubMed 33456856Merella F, Canchi-Murali N, Mossetti V. General principles of regional anaesthesia in children. BJA Educ. 2019 Oct;19(10):342-348. doi: 10.1016/j.bjae.2019.06.003. Epub 2019 Aug 24. No abstract available.
- Background: PubMed 31022606Orozco S, Munoz D, Jaramillo S, Herrera AM. Pediatric use of Pericapsular Nerve Group (PENG) block for hip surgical procedures. J Clin Anesth. 2019 Nov;57:143-144. doi: 10.1016/j.jclinane.2019.04.010. Epub 2019 Apr 22. No abstract available.
- Individual participant dataSharing planned: Yes. planned after the completion of the study and publication
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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.
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 Quadratus lumborum (QL) block group and Pericapsular Nerve Group (PENG) block group in people with Pediatric Postoperative Pain, run by Zagazig 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 2 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: finished, as of the sponsor's last update on 14 Jul 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?
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?
duration of sensory block (time frame: within 24 hour postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05444309, which also lists 8 linked publications.
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 14 Jul 2023.