Pericapsular Nerve Group Block (PENG Block)Phase 2NCT04899388
Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block
A Phase 2 study testing Pericapsular Nerve Block, Lumbar Erector Spinae Plane Block and Fentanyl in people with Pericapsular Nerve Group Block (PENG Block) and Lumbar Erector Spinae Plane Block, run by Zagazig University at 1 site in Egypt.
Trial summary
assess and compare the efficacy of pericapsular nerve group block wersus lumber erector spinae plane block in reducing postoperative pain within the first 24 hours after hip surgeries. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Pericapsular Nerve Group Block (PENG Block), Lumbar Erector Spinae Plane Block
- What is being tested?
- Pericapsular Nerve Block, Lumbar Erector Spinae Plane Block and Fentanyl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 20 Feb 2022
- Phase
- Phase 2
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 to 75 years old. American Society of anesthesiologists physical status II and III. Body mass index of 25 to 30 kg/m2.
Who cannot join
- Altered mental status. History of trauma or multiple fractures Uncontrolled hypertension and or diabetes. Coagulopathy. Preexisting advanced kidney, liver, or heart disease. Allergies or contraindications to the study drugs. Chronic use of opioids or corticosteroids.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Aculty of Medicine,Zagazig University
Zagazig, Sharqia Province, 44519
About this study
Official title: Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block as Postoperative Analgesia in Hip Surgeries: A Randomized Controlled Trial
assess and compare the efficacy of pericapsular nerve group block wersus lumber erector spinae plane block in reducing postoperative pain within the first 24 hours after hip surgeries.
Read the detailed description
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3groups each one containing 23 patients ,PENG group (n =23 ): The patients will receive Pericapsular Nerve Group Block (PENG Block) before positioning for spinal anesthesia.
ESPS group E (n =23 ): The patients will receive Lumbar Erector Spinae Plane Block before positioning for spinal anesthesia.
Control group C(n =23 ): patients received spinal anesthesia without any block.
- Being tested
- Pericapsular Nerve Block, Lumbar Erector Spinae Plane Block, Fentanyl
- Keywords
- Lumbar Erector Spinae Plane Block, Pericapsular Nerve Group Block (PENG Block)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular Nerve BlockProcedure or surgery
Also called PENG
regional anaesthia
Lumbar Erector Spinae Plane BlockProcedure or surgery
Also called LESB
regional anaesthia
FentanylDrug
intavenous
| Study group | Role | What they receive |
|---|---|---|
| PENG | Active comparator | the patients lied in the supine position. The probe was originally placed in a transverse plane above the anterior superior iliac spine in the ipsilateral surgical site and then counterclockwise rotated about 45 degrees to line up with the pubic ramus. The iliopubic eminence, iliopsoas muscle and tendon, femoral artery, and pectineus muscle were all visible in this view. By an in-plane technique, from lateral to medial, a 22-gauge, 80-mm needle was placed in the musculofascial plane between both the psoas tendon anteriorly and the pubic ramus posteriorly .The local anesthetic medication was delivered after negative aspiration while looking out for proper fluid distribution for a total volume of 20 mL of Bupivacaine 0.25% Receives: Procedure: Pericapsular Nerve Block |
| ESPB | Active comparator | TThe patient was positioned at the lateral decubitus posture in the ipsilateral surgical site. The convex USG transducer was moved from the midline to the side of the operation and positioned 4-6 cm lateral to the L3 spinous process in a longitudinal parasagittal plane. The needle was advanced using the in-plane superior-to-inferior approach. The needle was advanced with the tip introduced up to the plane anterior to the "erector spinae muscle" and the posterior surface of the L3 transverse process. 0.5-1 ml of normal saline was administered for hydrodissection and to ensure proper placement .If there was any resistance during administering local anesthesia, the needle was modified by drawing it back a few millimeters. the prepared local anesthetic solution 20 ml bupivacaine 0.25 % was delivered through the point between both the transverse process and the erector spinae muscle Receives: Procedure: Lumbar Erector Spinae Plane Block |
| control | Placebo comparator | patients received spinal anesthesia without any block Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to first postoperative rescue analgesia
the time to ask for the first postoperative analgesia (morphine) when the patient is reporting NRS ≥ 3
Measured: 24 hours postoperative
Secondary outcomes (6)
Block performance time (min)
time from placement of ultrasound probe on the patient's skin to the end of local anesthetic injection
Measured: immediately before surgery
onset of sensory block
the time between the end of the injection of local anesthetic (bupivacaine) and the loss of pin prick sensation using a sterile 25G needle in the operating field.
Measured: after the block
pain intensity
using an 11point numeric rating scale (NRS)(11) : 0: no pain,10=worst imaginable pain) 1-3Mild Pain (nagging, annoying, interfering little with activities of daily living (ADLs).
4-6Moderate Pain (interferes significantly with activities of daily living(ADLs) 7-10Severe Pain (disabling; unable to perform ADLs) at rest and during movement (during45-degree passive flexion of the hip with the ipsilateral knee flexed)
Measured: 30 minutes after the end of surgery ,3,6,12 hours postoperative.
The total dose of rescue analgesia
The total dose of rescue analgesia
Measured: 24 hours postoperative
adverse effects
nausea, vomiting ,hypotension ,bradycardia and hematoma
Measured: 24 hours postoperative
Patient satisfaction
related to block performance, post-operative pain relief was evaluated by an 11- point satisfaction score (0=unsatisfied and 10 = most satisfied), and the score was divided as follows 0-3 (not satisfied), 4-6 (partly satisfied), and 7-10 (highly satisfied).
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Jun 2021
- Primary completion30 Dec 2021
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pericapsular Nerve Group Block (PENG Block)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mohamed Medhat, Zagazig University
- Investigators
- Howida A kamal, M.D, Study director, zagazig UMarwa m Medhat, M.D, Principal investigator, zagazig U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899388
- Sponsor's protocol ID
- 6818
- Status last verified
- Jun 2023
- First submitted
- 19 Mar 2021
- Last updated
- 26 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block as Postoperative Analgesia in Hip Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04899388
- Acronym / sponsor ID
- 6818
- Keywords
- Lumbar Erector Spinae Plane Block, Pericapsular Nerve Group Block (PENG Block)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 24 May 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.
assess and compare the efficacy of pericapsular nerve group block wersus lumber erector spinae plane block in reducing postoperative pain within the first 24 hours after hip surgeries.
Detailed description
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3groups each one containing 23 patients ,PENG group (n =23 ): The patients will receive Pericapsular Nerve Group Block (PENG Block) before positioning for spinal anesthesia.
ESPS group E (n =23 ): The patients will receive Lumbar Erector Spinae Plane Block before positioning for spinal anesthesia.
Control group C(n =23 ): patients received spinal anesthesia without any block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PENG | Active comparator | Procedure: Pericapsular Nerve Blockthe patients lied in the supine position. The probe was originally placed in a transverse plane above the anterior superior iliac spine in the ipsilateral surgical site and then counterclockwise rotated about 45 degrees to line up with the pubic ramus. The iliopubic eminence, iliopsoas muscle and tendon, femoral artery, and pectineus muscle were all visible in this view. By an in-plane technique, from lateral to medial, a 22-gauge, 80-mm needle was placed in the musculofascial plane between both the psoas tendon anteriorly and the pubic ramus posteriorly .The local anesthetic medication was delivered after negative aspiration while looking out for proper fluid distribution for a total volume of 20 mL of Bupivacaine 0.25% |
| ESPB | Active comparator | Procedure: Lumbar Erector Spinae Plane BlockTThe patient was positioned at the lateral decubitus posture in the ipsilateral surgical site. The convex USG transducer was moved from the midline to the side of the operation and positioned 4-6 cm lateral to the L3 spinous process in a longitudinal parasagittal plane. The needle was advanced using the in-plane superior-to-inferior approach. The needle was advanced with the tip introduced up to the plane anterior to the "erector spinae muscle" and the posterior surface of the L3 transverse process. 0.5-1 ml of normal saline was administered for hydrodissection and to ensure proper placement .If there was any resistance during administering local anesthesia, the needle was modified by drawing it back a few millimeters. the prepared local anesthetic solution 20 ml bupivacaine 0.25 % was delivered through the point between both the transverse process and the erector spinae muscle |
| control | Placebo comparator | Drug: Fentanylpatients received spinal anesthesia without any block |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Aged 65 to 75 years old. American Society of anesthesiologists physical status II and III. Body mass index of 25 to 30 kg/m2.
Key exclusion criteria (1 listed)
- Altered mental status. History of trauma or multiple fractures Uncontrolled hypertension and or diabetes. Coagulopathy. Preexisting advanced kidney, liver, or heart disease. Allergies or contraindications to the study drugs. Chronic use of opioids or corticosteroids.
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 |
|---|---|---|
| Pericapsular Nerve BlockAlso: PENGregional anaesthia | Procedure or surgery | PENG |
| Lumbar Erector Spinae Plane BlockAlso: LESBregional anaesthia | Procedure or surgery | ESPB |
| Fentanylintavenous | Drug | control |
Primary outcome
the time to first postoperative rescue analgesia
Time frame: 24 hours postoperative
the time to ask for the first postoperative analgesia (morphine) when the patient is reporting NRS ≥ 3
6 secondary outcomes
Block performance time (min)
Time frame: immediately before surgery
onset of sensory block
Time frame: after the block
pain intensity
Time frame: 30 minutes after the end of surgery ,3,6,12 hours postoperative.
The total dose of rescue analgesia
Time frame: 24 hours postoperative
adverse effects
Time frame: 24 hours postoperative
Patient satisfaction
Time frame: 24 hours postoperative
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 26 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Pericapsular Nerve Group Block (PENG Block)
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Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
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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.
Howida A kamal, M.D study director
zagazig U
Marwa m Medhat, M.D principal investigator
zagazig U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pericapsular Nerve Block, Lumbar Erector Spinae Plane Block and Fentanyl in people with Pericapsular Nerve Group Block (PENG Block) and Lumbar Erector Spinae Plane Block, 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 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
the time to first postoperative rescue analgesia (time frame: 24 hours postoperative). 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 26 Jun 2023.