AnalgesiaNCT04423419
Peri-articular Nerve Group Block Versus Fascia Iliaca Block on Postoperative Pain After Hip Arthroscopy
A study testing PENG block, fascia iliaca block and IV analgesia in people with Analgesia, run by Assiut University.
Trial summary
The study aims to evaluate the efficacy of pericapsular nerve group block versus fascia iliaca block in reducing post operative pain within the first 24 hours following hip arthroscopy Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- PENG block, fascia iliaca block and IV analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 1 Apr 2022
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age 16-60 years old ASA physical status I or II scheduled for hip arthroscopy
Who cannot join
- pregnancy or breast feeding
- neurological deficits or neuropathy
- opioid addict
- local skin infections, bleeding diathesis, and coagulopathy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: the Efficacy of Peri-articular Nerve Group Block(PENG Block)Versus Fascia Iliaca Block on Immediate Post Operative Pain and Opioid Consumption After Hip Arthroscopy
The study aims to evaluate the efficacy of pericapsular nerve group block versus fascia iliaca block in reducing post operative pain within the first 24 hours following hip arthroscopy
Read the detailed description
In recent decades hip arthroscopy gained popularity and the number of procedures increase every year , due to the widening range of indications, as femoroacetabular impingement, labral tears, chondral injuries, loose bodies, osteonecrosis and septic arthritis Pain after hip arthroscopy due to several factors. divided in two regions. First the intra-articular where pain originates from the joint capsule (capsulotomy), a repaired labrum or bony resection. Outside the joint caused by traction, the portal tracts and extravasation of irrigation , soft tissue swelling.
the hip joint found to be innervated from the femoral nerve for its anterior part, the obturator nerve for its antero-medial part, the sciatic nerve for its posterior part, and the nerve to the quadratus femoris muscle for its postero-medial par
Pericapsular Nerve Group (PENG) Block aims to block the articular branches of the accessory obturator and femoral nerve Also, it could spread to block the obturator nerve and its articular branches the high articular branches from FN and AON are found between the anterior inferior iliac spine(AIIS) and the ilio pubic eminence (IPE), whereas the ON is located close to the inferomedial acetabulum.
The fascia iliaca compartment is a virtual space anteriorly limited by the posterior surface of the fascia iliaca, posteriorly by the iliacus muscle and is cranially in continuation with the space between quadratus lumborum muscle and its fascia . Three important nerves for hip innervation are located in this space, the femoral nerve, obturator nerve and lateral femoral cutaneous nerve
- Conditions
- Analgesia
- Being tested
- PENG block, fascia iliaca block, IV analgesia
- Keywords
- post operative pain, hip arthroscopy
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG blockProcedure or surgery
Also called injection of local anasthetics drug in peri-articular nerves of hip joint
The US probe placed in a transverse plane over the AIIS . the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle was inserted from lateral to medial to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic drug was injected while observing for adequate fluid spread for a total volume of 20 mL of Bupivacain 0.25%
fascia iliaca blockProcedure or surgery
Also called injection of local anathetics drug in fascia ilica space
ultrasound guidance landmarks are the anterior superior iliac spine and the pubic tubercle (inguinal ligament). The injection site along the lateral one-third of aline joining the anterior superior iliac spine (ASIS) and pubic tubercle (PT) targeting the compartment between fascia iliaca and fascia lata ,the total volume of injection is 20ml of Bupivacain 0.25%
IV analgesiaOther
Also called no block
IV analgesia
| Study group | Role | What they receive |
|---|---|---|
| A | Other | will undergo Peri -articular nerve group block for hip joint under ultrasound guide as analgesia post operative after hip arthroscopy Receives: Procedure: PENG block |
| B | Other | will undergo ultrasound guided fascia iliaca block as postoperative analgesia after hip arthroscopy Receives: Procedure: fascia iliaca block |
| C | Other | will receive ordinary IV analgesia during operation hip arthroscopy Receives: Other: IV analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the efficacy of pericapsular nerve group block versus fascia iliaca block in reducing post operative pain within the first 24 hours following hip arthroscopy
by question the patient about pain and its degree using visual analogue pain score( VAS score),it takes score from (0-10) according to severity of pain ,higher score indicates greater pain intensity.
Measured: 24 hours
Secondary outcomes (1)
duration of the analgesic effect of the block
evaluate duration of the analgesic effect of the block by calculating The time passed from block to the patient first analgesia request and total cumulative doses of analgesia
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 posted9 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- group A will undergo PENG block group B will undergo fascia iliaca block groupC will receive iv analgesia
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safa Sayed Noaman, Assiut University
- Investigators
- essam sharkawy, lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423419
- Sponsor's protocol ID
- postoperative pain
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1_ Colvin AC, Harrast J, Harner C. Trends in hip arthroscopy. J Bone Joint Surg Am 2012; 94: e23. 2_ Tan CO, Chong YM, Tran P et al. Surgical predictors of acute postoperative pain after hip arthroscopy. BMC Anesthesiol 2015; 15:96. 3- Jerry G. Xing,*yMD, MSc, FRCSC, Faraj W. Abdallah,zMD, Richard Brull,§MD, FRCPC,Stephanie Oldfield,§Andrew Dold,yMD, M. Lucas Murnaghan,||MD, MEd, FRCSC,and Daniel B. Whelan,{MD, FRCSC Preoperative Femoral Nerve Block for Hip Arthroscopy Randomized, Triple-Masked Controlled Trial The American Journal of Sports Medicine 2015 4_, Gardner E. The innervation of the hip joint. Anat Rec. 1948;101:353-371. 5_ Girón-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular nerve group (PENG) block for hip fracture. RegAnesth Pain Med. 2018; 43(8):859-63. 6_ Bhatia A, Hoydonckx Y, Peng P, Cohen SP. Radiofrequency procedures to relieve chronic hip pain. An evidence-based narrative review. Reg Anesth Pain Med. 2018;43:72-83. 7_S.M.White,R.Griffiths,J.Holloway,andA.Shannon,"AnaesthesiaforproximalfemoralfractureintheUK:firstreportfrom theNHShipfractureanaesthesianetwork,"Anaesthesia,vol.65, no.3,pp.243-248,2010.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Efficacy of Peri-articular Nerve Group Block(PENG Block)Versus Fascia Iliaca Block on Immediate Post Operative Pain and Opioid Consumption After Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT04423419
- Acronym / sponsor ID
- postoperative pain
- Conditions
- Analgesia
- Keywords
- post operative pain, hip arthroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 9 Jun 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.
The study aims to evaluate the efficacy of pericapsular nerve group block versus fascia iliaca block in reducing post operative pain within the first 24 hours following hip arthroscopy
Detailed description
In recent decades hip arthroscopy gained popularity and the number of procedures increase every year , due to the widening range of indications, as femoroacetabular impingement, labral tears, chondral injuries, loose bodies, osteonecrosis and septic arthritis Pain after hip arthroscopy due to several factors. divided in two regions. First the intra-articular where pain originates from the joint capsule (capsulotomy), a repaired labrum or bony resection. Outside the joint caused by traction, the portal tracts and extravasation of irrigation , soft tissue swelling.
the hip joint found to be innervated from the femoral nerve for its anterior part, the obturator nerve for its antero-medial part, the sciatic nerve for its posterior part, and the nerve to the quadratus femoris muscle for its postero-medial par
Pericapsular Nerve Group (PENG) Block aims to block the articular branches of the accessory obturator and femoral nerve Also, it could spread to block the obturator nerve and its articular branches the high articular branches from FN and AON are found between the anterior inferior iliac spine(AIIS) and the ilio pubic eminence (IPE), whereas the ON is located close to the inferomedial acetabulum.
The fascia iliaca compartment is a virtual space anteriorly limited by the posterior surface of the fascia iliaca, posteriorly by the iliacus muscle and is cranially in continuation with the space between quadratus lumborum muscle and its fascia . Three important nerves for hip innervation are located in this space, the femoral nerve, obturator nerve and lateral femoral cutaneous nerve
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- group A will undergo PENG block group B will undergo fascia iliaca block groupC will receive iv analgesia
| Arm | Type | Receives |
|---|---|---|
| A | Other | Procedure: PENG blockwill undergo Peri -articular nerve group block for hip joint under ultrasound guide as analgesia post operative after hip arthroscopy |
| B | Other | Procedure: fascia iliaca blockwill undergo ultrasound guided fascia iliaca block as postoperative analgesia after hip arthroscopy |
| C | Other | Other: IV analgesiawill receive ordinary IV analgesia during operation hip arthroscopy |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- age 16-60 years old ASA physical status I or II scheduled for hip arthroscopy
Key exclusion criteria (4 listed)
- pregnancy or breast feeding
- neurological deficits or neuropathy
- opioid addict
- local skin infections, bleeding diathesis, and coagulopathy
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 |
|---|---|---|
| PENG blockAlso: injection of local anasthetics drug in peri-articular nerves of hip jointThe US probe placed in a transverse plane over the AIIS . the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle was inserted from lateral to medial to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic drug was injected while observing for adequate fluid spread for a total volume of 20 mL of Bupivacain 0.25% | Procedure or surgery | A |
| fascia iliaca blockAlso: injection of local anathetics drug in fascia ilica spaceultrasound guidance landmarks are the anterior superior iliac spine and the pubic tubercle (inguinal ligament). The injection site along the lateral one-third of aline joining the anterior superior iliac spine (ASIS) and pubic tubercle (PT) targeting the compartment between fascia iliaca and fascia lata ,the total volume of injection is 20ml of Bupivacain 0.25% | Procedure or surgery | B |
| IV analgesiaAlso: no blockIV analgesia | Other | C |
Primary outcome
evaluate the efficacy of pericapsular nerve group block versus fascia iliaca block in reducing post operative pain within the first 24 hours following hip arthroscopy
Time frame: 24 hours
by question the patient about pain and its degree using visual analogue pain score( VAS score),it takes score from (0-10) according to severity of pain ,higher score indicates greater pain intensity.
1 secondary outcome
duration of the analgesic effect of the block
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 9 Jun 2020.
- Background1_ Colvin AC, Harrast J, Harner C. Trends in hip arthroscopy. J Bone Joint Surg Am 2012; 94: e23. 2_ Tan CO, Chong YM, Tran P et al. Surgical predictors of acute postoperative pain after hip arthroscopy. BMC Anesthesiol 2015; 15:96. 3- Jerry G. Xing,*yMD, MSc, FRCSC, Faraj W. Abdallah,zMD, Richard Brull,§MD, FRCPC,Stephanie Oldfield,§Andrew Dold,yMD, M. Lucas Murnaghan,||MD, MEd, FRCSC,and Daniel B. Whelan,{MD, FRCSC Preoperative Femoral Nerve Block for Hip Arthroscopy Randomized, Triple-Masked Controlled Trial The American Journal of Sports Medicine 2015 4_, Gardner E. The innervation of the hip joint. Anat Rec. 1948;101:353-371. 5_ Girón-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular nerve group (PENG) block for hip fracture. RegAnesth Pain Med. 2018; 43(8):859-63. 6_ Bhatia A, Hoydonckx Y, Peng P, Cohen SP. Radiofrequency procedures to relieve chronic hip pain. An evidence-based narrative review. Reg Anesth Pain Med. 2018;43:72-83. 7_S.M.White,R.Griffiths,J.Holloway,andA.Shannon,"AnaesthesiaforproximalfemoralfractureintheUK:firstreportfrom theNHShipfractureanaesthesianetwork,"Anaesthesia,vol.65, no.3,pp.243-248,2010.
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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.
essam sharkawy, lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing PENG block, fascia iliaca block and IV analgesia in people with Analgesia, run by Assiut University.
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 4 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 safaa noaman, resident (201030333468, safa2gmsy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the efficacy of pericapsular nerve group block versus fascia iliaca block in reducing post operative pain within the first 24 hours following hip arthroscopy (time frame: 24 hours). 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 NCT04423419, which also lists 1 linked publication.
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 9 Jun 2020.