Post Operative Pain, ChronicNCT05050487
Pericapsular Nerve Group Block Versus Lumber Erector Spinae Plane Block for Pain Management After Total Hip Arthroplasty
A study testing PENG block and lumbar erector spinae plane block in people with Post Operative Pain, Chronic, run by Assiut University.
Trial summary
Pain is a major problem that has to be dealt with in case of hip fracture, as it presents an obstacle for examination, positioning for receiving neuroaxial anesthesia and postoperative mobility and physiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Operative Pain, Chronic
- What is being tested?
- PENG block and lumbar erector spinae plane block
- Type of treatment
- 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
- 30 Jun 2022to 30 Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA grade 1\&2 \&3
- Adult patients (Age >18 yrs)
- Eligible patients were aged 18 years or older, were admitted for hip arthroplasty (THA or HA) for femoral neck fracture, and had undergone a preoperative RA technique (PENG block or lumbar erector spinae plane block)
Who cannot join
- Patients with chronic pain before surgery (taking opioids)
- Patients with multiple trauma
- Patients who could not assess pain reliably (dementia)
- Patients who in anticoagulation
- Patient refused
- Infection at the side of injection
Trial locations and contacts
No sites are listed yet.
About this study
Pain is a major problem that has to be dealt with in case of hip fracture, as it presents an obstacle for examination, positioning for receiving neuroaxial anesthesia and postoperative mobility and physiotherapy. With the introduction of ultrasound in regional anesthesia and peripheral nerve blocks, regional analgesia float to the surface as a substitute for opioids with less side effects Lumbar erector spinae plane block has emerged as a reliable analgesic option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed pericapsular nerve group block or PENG block, that selectively targets the articular branches of the femoral and obturator nerves while sparing their motor components
Read the detailed description
Pain is a major problem that has to be dealt with in case of hip fracture, as it presents an obstacle for examination, positioning for receiving neuroaxial anesthesia and postoperative mobility and physiotherapy. With the introduction of ultrasound in regional anesthesia and peripheral nerve blocks, regional analgesia float to the surface as a substitute for opioids with less side effects Lumbar erector spinae plane block has emerged as a reliable analgesic option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed pericapsular nerve group block or PENG block, that selectively targets the articular branches of the femoral and obturator nerves while sparing their motor components The pericapsular nerve group (PENG) block is an ultrasound-guided approach first de-scribed by Giron-Arango et al. for the blockade of the articular branches of the femoral (FN), obturator (ON) and accessory obturator (AON) nerve that provide sensory innervation to the an¬terior hip capsule. It has been developed as an alternative regional anesthesia technique for the management of acute pain after hip fractures, but its applications are expanding.
Currently, the PENG block has been used to control and reduce pain in hip-related procedures.
There are reports of PENG blocks used as surgical anesthetic techniques for hip arthroplasty (in combination with local anesthetic and intravenous analgesics) or hip arthroscopy (in combination with lateral femoral cutaneous nerve [LFCN] block). There is a report of a PENG block used as analgesic technique for sickle cell disease vaso-occlusive crisis and a PENG radiofrequency ablation for osteoarthritis analgesia. There are also reports about the use of a PENG block for non-hip related interventions, such as leg vein ligation and stripping, medial thigh surgery, prevention of adductor muscle spasm during transurethral resection of bladder and below-knee amputation in association with popliteal sciatic nerve block.These latter cases further extended the application of the PENG block beyond the hip-related area.
So far, most of the reports describe preoperative or postoperative single-shot blocks, while there are only few case reports of continuous PENG blocks.
Due to the novelty of this technique, there are still ongoing debates about the best injection point as well as the best anesthetic concentration and the total volume to be injected.
Defined in the last decade, erector spinae plane block (ESPB) is one of the more frequently used interfacial plans, and it has been the most discussed block among the recently defined techniques. Lumbar ESPB administered at lumbar levels is relatively novel and is a new horizon for regional anesthesia and pain practice.(14)
- Conditions
- Post Operative Pain, Chronic
- Being tested
- PENG block, lumbar erector spinae plane block
- Medical subject headings
- 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 pericapsular nerve group block
The PENG block is performed under US guid¬ance, . The pa¬tient is placed in the supine position a curvilinear low-fre¬quency ultrasound probe (2-5 MHz) is initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe approximately 30-45 degrees . .
The needle, usually a 22-G80-mm echogenic device, is inserted from lateral to medial with an in-plane approach to place the tip in the plane between the psoas tendon anteriorly and the pu¬bic ramus posteriorly .
After needle insertion and following negative aspiration, the local anesthetic is injected . The volume used of 20 ml of(L-bupivacaine; concentration 0,25% ) . This fascial plane appeared to continue in the hip pericapsular plane.
lumbar erector spinae plane blockProcedure or surgery
Also called ESPB
The lumbar erector spinae block is performed under US guid¬ance, after adequate skin disinfection The patient is placed in the lateral decubitus position according to the selected site of surgical intervention.
The 4th lumbar vertebral level will determined The convex USG transducer was placed at the mid-vertebral line in the sagittal plane. The transducer was shifted from the midline, 3.5-4 cm laterally to the side of the surgery to visualize the erector spinae muscle and transverse process . 0.5-1 ml of the prepared LA solution (20 ml bupivacaine 0.25%). All LA was administered to this location between the transverse process and the erector spinae muscle.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | patient will recieve pericapsular nerve group block Receives: Procedure: PENG block |
| treatement | Experimental | patient will receive lumbar erector spinae plane block Receives: Procedure: lumbar erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
the time passed from block to the patient's first analgesic request in hours
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start30 Jun 2022 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, ChronicStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trail
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdeltwab Younis Tamam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050487
- Sponsor's protocol ID
- T1991
- Status last verified
- Apr 2022
- First submitted
- 10 Sep 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group Block Versus Lumber Erector Spinae Plane Block for Pain Management After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05050487
- Acronym / sponsor ID
- T1991
- Conditions
- Post Operative Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 20 Sep 2021 (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.
Pain is a major problem that has to be dealt with in case of hip fracture, as it presents an obstacle for examination, positioning for receiving neuroaxial anesthesia and postoperative mobility and physiotherapy. With the introduction of ultrasound in regional anesthesia and peripheral nerve blocks, regional analgesia float to the surface as a substitute for opioids with less side effects Lumbar erector spinae plane block has emerged as a reliable analgesic option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed pericapsular nerve group block or PENG block, that selectively targets the articular branches of the femoral and obturator nerves while sparing their motor components
Detailed description
Pain is a major problem that has to be dealt with in case of hip fracture, as it presents an obstacle for examination, positioning for receiving neuroaxial anesthesia and postoperative mobility and physiotherapy. With the introduction of ultrasound in regional anesthesia and peripheral nerve blocks, regional analgesia float to the surface as a substitute for opioids with less side effects Lumbar erector spinae plane block has emerged as a reliable analgesic option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed pericapsular nerve group block or PENG block, that selectively targets the articular branches of the femoral and obturator nerves while sparing their motor components The pericapsular nerve group (PENG) block is an ultrasound-guided approach first de-scribed by Giron-Arango et al. for the blockade of the articular branches of the femoral (FN), obturator (ON) and accessory obturator (AON) nerve that provide sensory innervation to the an¬terior hip capsule. It has been developed as an alternative regional anesthesia technique for the management of acute pain after hip fractures, but its applications are expanding.
Currently, the PENG block has been used to control and reduce pain in hip-related procedures.
There are reports of PENG blocks used as surgical anesthetic techniques for hip arthroplasty (in combination with local anesthetic and intravenous analgesics) or hip arthroscopy (in combination with lateral femoral cutaneous nerve [LFCN] block). There is a report of a PENG block used as analgesic technique for sickle cell disease vaso-occlusive crisis and a PENG radiofrequency ablation for osteoarthritis analgesia. There are also reports about the use of a PENG block for non-hip related interventions, such as leg vein ligation and stripping, medial thigh surgery, prevention of adductor muscle spasm during transurethral resection of bladder and below-knee amputation in association with popliteal sciatic nerve block.These latter cases further extended the application of the PENG block beyond the hip-related area.
So far, most of the reports describe preoperative or postoperative single-shot blocks, while there are only few case reports of continuous PENG blocks.
Due to the novelty of this technique, there are still ongoing debates about the best injection point as well as the best anesthetic concentration and the total volume to be injected.
Defined in the last decade, erector spinae plane block (ESPB) is one of the more frequently used interfacial plans, and it has been the most discussed block among the recently defined techniques. Lumbar ESPB administered at lumbar levels is relatively novel and is a new horizon for regional anesthesia and pain practice.(14)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trail
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Procedure: PENG blockpatient will recieve pericapsular nerve group block |
| treatement | Experimental | Procedure: lumbar erector spinae plane blockpatient will receive lumbar erector spinae plane block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA grade 1\&2 \&3
- Adult patients (Age >18 yrs)
- Eligible patients were aged 18 years or older, were admitted for hip arthroplasty (THA or HA) for femoral neck fracture, and had undergone a preoperative RA technique (PENG block or lumbar erector spinae plane block)
Key exclusion criteria (6 listed)
- Patients with chronic pain before surgery (taking opioids)
- Patients with multiple trauma
- Patients who could not assess pain reliably (dementia)
- Patients who in anticoagulation
- Patient refused
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: pericapsular nerve group blockThe PENG block is performed under US guid¬ance, . The pa¬tient is placed in the supine position a curvilinear low-fre¬quency ultrasound probe (2-5 MHz) is initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe approximately 30-45 degrees . . The needle, usually a 22-G80-mm echogenic device, is inserted from lateral to medial with an in-plane approach to place the tip in the plane between the psoas tendon anteriorly and the pu¬bic ramus posteriorly . After needle insertion and following negative aspiration, the local anesthetic is injected . The volume used of 20 ml of(L-bupivacaine; concentration 0,25% ) . This fascial plane appeared to continue in the hip pericapsular plane. | Procedure or surgery | treatment |
| lumbar erector spinae plane blockAlso: ESPBThe lumbar erector spinae block is performed under US guid¬ance, after adequate skin disinfection The patient is placed in the lateral decubitus position according to the selected site of surgical intervention. The 4th lumbar vertebral level will determined The convex USG transducer was placed at the mid-vertebral line in the sagittal plane. The transducer was shifted from the midline, 3.5-4 cm laterally to the side of the surgery to visualize the erector spinae muscle and transverse process . 0.5-1 ml of the prepared LA solution (20 ml bupivacaine 0.25%). All LA was administered to this location between the transverse process and the erector spinae muscle. | Procedure or surgery | treatement |
Primary outcome
Duration of analgesia
Time frame: 24 hour
the time passed from block to the patient's first analgesic request in hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PENG block and lumbar erector spinae plane block in people with Post Operative Pain, Chronic, 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 3 inclusion and 6 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 28 Apr 2022. 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 Abdeltwab Younis (01098518513, abdeltwabyonis91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of analgesia (time frame: 24 hour). 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 28 Apr 2022.