Lumbar Erector Spinae Plane BlockPhase 4NCT05930171
Combined Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block in Patients Undergoing Hip Surgeries
A Phase 4 study testing Ultrasound guided L-ESPB and PENG block using Bupivacaine and Postoperative conventional analgesia in form of Acetaminophen in people with Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block (PENG Block), run by Menoufia University at 1 site in Egypt.
Trial summary
The investigators are going to evaluate the postoperative analgesic efficacy of combined LESPB and PENG block after hip surgeries. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Erector Spinae Plane Block, Pericapsular Nerve Group Block (PENG Block)
- What is being tested?
- Ultrasound guided L-ESPB and PENG block using Bupivacaine and Postoperative conventional analgesia in form of Acetaminophen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Dec 2023
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 years old
- American Society of Anesthesiologists (ASA) class I to III
- Both sex
- Scheduled for hip surgery.
Who cannot join
- Refusal to participate
- Allergy to any of the study drugs
- Bleeding disorder
- Localized infection
- Neurological disease
- Renal impairment
Show all 10Show fewer
- Psychological disorders
- Opioid dependent
- Intellectual disability (patients unable to express pain with visual analogue)
- Morbid obesity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Combined Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block in Patients Undergoing Hip Surgeries
The investigators are going to evaluate the postoperative analgesic efficacy of combined LESPB and PENG block after hip surgeries.
Read the detailed description
Hip surgeries are very common surgeries and has high postoperative pain potential. There are different ways to execute postoperative analgesia and each of them has advantages and disadvantages. As the patients submitted to this procedure are usually older and with multiple comorbidities, analgesia options with better profile of adverse effects should be preferred. Peripheral nerve block with long-acting local anesthetics is very suitable in this situation, in comparison with systemic or neuraxial opioids.
Pain control after total hip arthroplasty (THA) can be challenging because of complex innervation of the hip joint from both the lumbar and sacral nerve plexus. pain was the cause of 12% of unplanned hospital patient admissions, 60% of these patients were admitted for orthopedic concerns. The consequences of severe postoperative pain are prolonged hospital stay, increase hospital readmission, precipitation in the use of opioids with subsequent increase in postoperative nausea and vomiting, and overall low patient satisfaction. Furthermore, postoperative pain can seriously impact the physical and mental health of the patient and lead to secondary complications such as nausea, vomiting, slowed bowel movements, muscle spasms, thrombosis, cardiopulmonary complications and delayed recovery of organ functions.
The hip joint is innervated by the articular branches of multiple nerves that emerge from the lumbosacral plexus (L2-S1). The nerve supply to a specific region of the joint typically corresponds to the innervation of the muscle that crosses it :-
- The femoral nerve innervates the anterior aspect
- The obturator nerve supplies the inferior aspect
- The superior gluteal nerve supplies the superior aspect
- The nerve to the quadratus femoris innervates the posterior aspect.
Hip joint capsular innervation was found to consistently involve the femoral and obturator nerves, which supply the anterior capsule, and the nerve to the quadratus femoris, which supplies the posterior capsule.
Lumbar erector spinae plane block (LESPB) local anesthetics spread to lumbar paravertebral space and lumbar nerve roots, reaching the nerves responsible for the innervation of the hip joint lumbar plexus nerves - femoral, obturator and lateral femoral cutaneous nerves - providing analgesia for hip surgery. LESPB can be a block easier to perform than other options for hip surgery analgesia, such as posterior lumbar plexus.
(L-ESPB) is an effective analgesic technique after hip surgeries. However, an insufficient sensorial blockade of the medial part of the thigh which is innervated by the obturator nerve.
The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. It has been successfully used as an alternative regional anaesthesia 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.
After all the investigators hypothesize that combination of LESPB and PENG block can be more effective in pain control after hip surgeries.
- Being tested
- Ultrasound guided L-ESPB and PENG block using Bupivacaine, Postoperative conventional analgesia in form of Acetaminophen
- Keywords
- Lumbar Erector Spinae Plane Block, Pericapsular Nerve Group Block, Hip Surgeries, L-ESPB, PENG block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided L-ESPB and PENG block using BupivacaineProcedure or surgery
Also called Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block
Combined Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block in Patients Undergoing Hip Surgeries
Postoperative conventional analgesia in form of AcetaminophenDrug
Also called Conventional analgesia
Postoperative conventional analgesia in form of acetaminophen 15 mg/kg/6hrs
| Study group | Role | What they receive |
|---|---|---|
| Group A: L-ESPB and PENG | Active comparator | receiving after end of hip surgery (PENG) block first and (LESPB) at lumber 4 vertebrae level Receives: Procedure: Ultrasound guided L-ESPB and PENG block using Bupivacaine |
| Group B: conventional analgesia | Active comparator | receiving postoperative conventional analgesia in form of acetaminophen 15 mg/kg/6hrs Receives: Drug: Postoperative conventional analgesia in form of Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)
Measured: at 1 hour after the block
Postoperative pain intensity
Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)
Measured: at 3 hour after the block
Postoperative pain intensity
Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)
Measured: at 6 hour after the block
Postoperative pain intensity
Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)
Measured: at 12 hour after the block
Postoperative pain intensity
Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)
Measured: at 24 hour after the block
Secondary outcomes (8)
Vital signs
Heart Rate
Measured: assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
Vital signs
Arterial Blood Pressure
Measured: assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
Vital signs
Arterial Oxygen Saturation
Measured: assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
Time to first analgesic administration
Time to first analgesic administration
Measured: 24 hours postoperative
Total Analgesic Requirements
Total analgesic requirements in 24 hours postoperative
Measured: 24 hours postoperative
Patient satisfaction
patients will be asked to assess their satisfaction :-
- I Very satisfied.
- II sometimes satisfied.
- III Neither satisfied nor dissatisfied.
- IV Somewhat dissatisfied.
- V Very dissatisfied.
Measured: 24 hours after the block
Adverse events
Either hematoma, infection, postoperative nausea, vomiting orlocal anesthetic systemic toxicity
Measured: 24 hours after the block
Block failure (patients still feeling pain immediately after 1 hour from block)
Block failure (patients still feeling pain immediately after 1 hour from block)
Measured: 1 hour after the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Feb 2023
- Primary completion1 Aug 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Lumbar Erector Spinae Plane BlockStudies of the same condition, open and under way.
- More trials run by Menoufia 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Walash, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930171
- Sponsor's protocol ID
- Lumbar ESPB and PENG block
- Status last verified
- Dec 2023
- First submitted
- 4 Jun 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahiskalioglu A, Tulgar S, Celik M, Ozer Z, Alici HA, Aydin ME. Lumbar Erector Spinae Plane Block as a Main Anesthetic Method for Hip Surgery in High Risk Elderly Patients: Initial Experience with a Magnetic Resonance Imaging. Eurasian J Med. 2020 Feb;52(1):16-20. doi: 10.5152/eurasianjmed.2020.19224.
PubMed 32158307Santonastaso DP, De Chiara A, Kraus E, Bagaphou TC, Tognu A, Agnoletti V. Ultrasound guided erector spinae plane block: an alternative technique for providing analgesia after total hip arthroplasty surgery? Minerva Anestesiol. 2019 Jul;85(7):801-802. doi: 10.23736/S0375-9393.19.13459-1. Epub 2019 Mar 12. No abstract available.
PubMed 30871306Tulgar S, Kose HC, Selvi O, Senturk O, Thomas DT, Ermis MN, Ozer Z. Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Hip and Proximal Femur Surgery: A Prospective Randomized Feasibility Study. Anesth Essays Res. 2018 Oct-Dec;12(4):825-831. doi: 10.4103/aer.AER_142_18.
PubMed 30662115Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
PubMed 29522966Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. No abstract available.
PubMed 29149734Giron-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 30063657Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Pericapsular nerve group block: an overview. Minerva Anestesiol. 2021 Apr;87(4):458-466. doi: 10.23736/S0375-9393.20.14798-9. Epub 2021 Jan 12.
PubMed 33432791Lin DY, Morrison C, Brown B, Saies AA, Pawar R, Vermeulen M, Anderson SR, Lee TS, Doornberg J, Kroon HM, Jaarsma RL. Pericapsular nerve group (PENG) block provides improved short-term analgesia compared with the femoral nerve block in hip fracture surgery: a single-center double-blinded randomized comparative trial. Reg Anesth Pain Med. 2021 May;46(5):398-403. doi: 10.1136/rapm-2020-102315. Epub 2021 Feb 26.
PubMed 33637625Del Buono R, Padua E, Pascarella G, Soare CG, Barbara E. Continuous PENG block for hip fracture: a case series. Reg Anesth Pain Med. 2020 Oct;45(10):835-838. doi: 10.1136/rapm-2020-101446. Epub 2020 Aug 12.
PubMed 32796133Roy R, Agarwal G, Pradhan C, Kuanar D. Total postoperative analgesia for hip surgeries, PENG block with LFCN block. Reg Anesth Pain Med. 2019 Mar 28:rapm-2019-100454. doi: 10.1136/rapm-2019-100454. Online ahead of print. No abstract available.
PubMed 30923252Kukreja P, Schuster B, Northern T, Sipe S, Naranje S, Kalagara H. Pericapsular Nerve Group (PENG) Block in Combination With the Quadratus Lumborum Block Analgesia for Revision Total Hip Arthroplasty: A Retrospective Case Series. Cureus. 2020 Dec 23;12(12):e12233. doi: 10.7759/cureus.12233.
PubMed 33500856
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Combined Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block in Patients Undergoing Hip Surgeries
- ClinicalTrials.gov ID
- NCT05930171
- Acronym / sponsor ID
- Lumbar ESPB and PENG block
- Keywords
- Lumbar Erector Spinae Plane Block, Pericapsular Nerve Group Block, Hip Surgeries, L-ESPB, PENG block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 5 Jul 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.
The investigators are going to evaluate the postoperative analgesic efficacy of combined LESPB and PENG block after hip surgeries.
Detailed description
Hip surgeries are very common surgeries and has high postoperative pain potential. There are different ways to execute postoperative analgesia and each of them has advantages and disadvantages. As the patients submitted to this procedure are usually older and with multiple comorbidities, analgesia options with better profile of adverse effects should be preferred. Peripheral nerve block with long-acting local anesthetics is very suitable in this situation, in comparison with systemic or neuraxial opioids.
Pain control after total hip arthroplasty (THA) can be challenging because of complex innervation of the hip joint from both the lumbar and sacral nerve plexus. pain was the cause of 12% of unplanned hospital patient admissions, 60% of these patients were admitted for orthopedic concerns. The consequences of severe postoperative pain are prolonged hospital stay, increase hospital readmission, precipitation in the use of opioids with subsequent increase in postoperative nausea and vomiting, and overall low patient satisfaction. Furthermore, postoperative pain can seriously impact the physical and mental health of the patient and lead to secondary complications such as nausea, vomiting, slowed bowel movements, muscle spasms, thrombosis, cardiopulmonary complications and delayed recovery of organ functions.
The hip joint is innervated by the articular branches of multiple nerves that emerge from the lumbosacral plexus (L2-S1). The nerve supply to a specific region of the joint typically corresponds to the innervation of the muscle that crosses it :-
- The femoral nerve innervates the anterior aspect
- The obturator nerve supplies the inferior aspect
- The superior gluteal nerve supplies the superior aspect
- The nerve to the quadratus femoris innervates the posterior aspect.
Hip joint capsular innervation was found to consistently involve the femoral and obturator nerves, which supply the anterior capsule, and the nerve to the quadratus femoris, which supplies the posterior capsule.
Lumbar erector spinae plane block (LESPB) local anesthetics spread to lumbar paravertebral space and lumbar nerve roots, reaching the nerves responsible for the innervation of the hip joint lumbar plexus nerves - femoral, obturator and lateral femoral cutaneous nerves - providing analgesia for hip surgery. LESPB can be a block easier to perform than other options for hip surgery analgesia, such as posterior lumbar plexus.
(L-ESPB) is an effective analgesic technique after hip surgeries. However, an insufficient sensorial blockade of the medial part of the thigh which is innervated by the obturator nerve.
The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. It has been successfully used as an alternative regional anaesthesia 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.
After all the investigators hypothesize that combination of LESPB and PENG block can be more effective in pain control after hip surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: L-ESPB and PENG | Active comparator | Procedure: Ultrasound guided L-ESPB and PENG block using Bupivacainereceiving after end of hip surgery (PENG) block first and (LESPB) at lumber 4 vertebrae level |
| Group B: conventional analgesia | Active comparator | Drug: Postoperative conventional analgesia in form of Acetaminophenreceiving postoperative conventional analgesia in form of acetaminophen 15 mg/kg/6hrs |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-70 years old
- American Society of Anesthesiologists (ASA) class I to III
- Both sex
- Scheduled for hip surgery.
Key exclusion criteria (10 listed)
- Refusal to participate
- Allergy to any of the study drugs
- Bleeding disorder
- Localized infection
- Neurological disease
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 L-ESPB and PENG block using BupivacaineAlso: Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group BlockCombined Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block in Patients Undergoing Hip Surgeries | Procedure or surgery | Group A: L-ESPB and PENG |
| Postoperative conventional analgesia in form of AcetaminophenAlso: Conventional analgesiaPostoperative conventional analgesia in form of acetaminophen 15 mg/kg/6hrs | Drug | Group B: conventional analgesia |
Primary outcome
Postoperative pain intensity
Time frame: at 1 hour after the block
Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)
Postoperative pain intensity
Time frame: at 3 hour after the block
Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)
Postoperative pain intensity
Time frame: at 6 hour after the block
Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)
Postoperative pain intensity
Time frame: at 12 hour after the block
Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)
Postoperative pain intensity
Time frame: at 24 hour after the block
Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)
8 secondary outcomes
Vital signs
Time frame: assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
Vital signs
Time frame: assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
Vital signs
Time frame: assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements
Time to first analgesic administration
Time frame: 24 hours postoperative
Total Analgesic Requirements
Time frame: 24 hours postoperative
Patient satisfaction
Time frame: 24 hours after the block
Adverse events
Time frame: 24 hours after the block
Block failure (patients still feeling pain immediately after 1 hour from block)
Time frame: 1 hour after the block
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 28 Dec 2023.
- Background: PubMed 32158307Ahiskalioglu A, Tulgar S, Celik M, Ozer Z, Alici HA, Aydin ME. Lumbar Erector Spinae Plane Block as a Main Anesthetic Method for Hip Surgery in High Risk Elderly Patients: Initial Experience with a Magnetic Resonance Imaging. Eurasian J Med. 2020 Feb;52(1):16-20. doi: 10.5152/eurasianjmed.2020.19224.
- Background: PubMed 30871306Santonastaso DP, De Chiara A, Kraus E, Bagaphou TC, Tognu A, Agnoletti V. Ultrasound guided erector spinae plane block: an alternative technique for providing analgesia after total hip arthroplasty surgery? Minerva Anestesiol. 2019 Jul;85(7):801-802. doi: 10.23736/S0375-9393.19.13459-1. Epub 2019 Mar 12. No abstract available.
- Background: PubMed 30662115Tulgar S, Kose HC, Selvi O, Senturk O, Thomas DT, Ermis MN, Ozer Z. Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Hip and Proximal Femur Surgery: A Prospective Randomized Feasibility Study. Anesth Essays Res. 2018 Oct-Dec;12(4):825-831. doi: 10.4103/aer.AER_142_18.
- Background: PubMed 29522966Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
- Background: PubMed 29149734Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. 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 33432791Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Pericapsular nerve group block: an overview. Minerva Anestesiol. 2021 Apr;87(4):458-466. doi: 10.23736/S0375-9393.20.14798-9. Epub 2021 Jan 12.
- Background: PubMed 33637625Lin DY, Morrison C, Brown B, Saies AA, Pawar R, Vermeulen M, Anderson SR, Lee TS, Doornberg J, Kroon HM, Jaarsma RL. Pericapsular nerve group (PENG) block provides improved short-term analgesia compared with the femoral nerve block in hip fracture surgery: a single-center double-blinded randomized comparative trial. Reg Anesth Pain Med. 2021 May;46(5):398-403. doi: 10.1136/rapm-2020-102315. Epub 2021 Feb 26.
- Background: PubMed 32796133Del Buono R, Padua E, Pascarella G, Soare CG, Barbara E. Continuous PENG block for hip fracture: a case series. Reg Anesth Pain Med. 2020 Oct;45(10):835-838. doi: 10.1136/rapm-2020-101446. Epub 2020 Aug 12.
- Background: PubMed 30923252Roy R, Agarwal G, Pradhan C, Kuanar D. Total postoperative analgesia for hip surgeries, PENG block with LFCN block. Reg Anesth Pain Med. 2019 Mar 28:rapm-2019-100454. doi: 10.1136/rapm-2019-100454. Online ahead of print. No abstract available.
- Background: PubMed 33500856Kukreja P, Schuster B, Northern T, Sipe S, Naranje S, Kalagara H. Pericapsular Nerve Group (PENG) Block in Combination With the Quadratus Lumborum Block Analgesia for Revision Total Hip Arthroplasty: A Retrospective Case Series. Cureus. 2020 Dec 23;12(12):e12233. doi: 10.7759/cureus.12233.
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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 Phase 4 study testing Ultrasound guided L-ESPB and PENG block using Bupivacaine and Postoperative conventional analgesia in form of Acetaminophen in people with Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block (PENG Block), run by Menoufia 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 4 inclusion and 10 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 28 Dec 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative pain intensity (time frame: at 1 hour after the block). The study lists 5 primary outcomes in all. 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 NCT05930171, which also lists 11 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 28 Dec 2023.