Pain, PostoperativeNCT06144931
Efficacy of Pericapsular Nerve Group (PENG) Block for Hip Surgeries
A study testing PENG Block in people with Pain, Postoperative, run by Suez Canal University at 1 site in Egypt.
Trial summary
To study the efficacy of the PENG block on the duration of postoperative analgesia. There are two groups of patients, who are undergoing hip joint surgeries, one group (Control Group) will receive spinal anesthesia only while the other group (PENG Group) will receive PENG block before spinal anesthesia. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- PENG Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Mar 2024
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hip fracture who will be subjected to surgical treatment
- ASA physical status 1, 2
Who cannot join
- Patients with chronic pain before surgery (taking opioids).
- Patients with multiple trauma
- Patients who could not assess pain reliably (dementia).
- Substance abuse and prolonged intake of sedative drugs.
- Morbid obese patients (BMI>35).
- Patients who have open wounds or infection at the site of the block.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Suez Canal University
Ismailia
Aiman A. Al-Touny, MD, 01008185785, aimantouny@yahoo.com
Mariam Khattabi, M.B.B.CH
About this study
Official title: The Impact of Pericapsular Nerve Group Block on The Duration of Post-Operative Analgesia Following Hip Joint Surgeries
To study the efficacy of the PENG block on the duration of postoperative analgesia. There are two groups of patients, who are undergoing hip joint surgeries, one group (Control Group) will receive spinal anesthesia only while the other group (PENG Group) will receive PENG block before spinal anesthesia.
Read the detailed description
Research Question:
Is PENG block effective in prolonging the duration of postoperative analgesia when compared to patients undergoing spinal anesthesia only?
Research Hypothesis:
PENG block is effective in prolonging the duration of postoperative analgesia and reducing postoperative pain.
Aim:
To improve the outcome of hip joint surgeries by decreasing the postoperative pain and early mobilization by performing PENG block to patients undergoing hip joint surgeries.
Method of randomization:
This clinical trial will be randomized through computer software that generates random number table and patients will be allocated randomly to one of the two groups.
Sample size:
The sample size was determined by using the following equation:(Charan J et al. 2013) N =(2 δ^(2 ) 〖(Z_α+ Z_β)〗^2)/D^2 δ=Standard deviation of the outcome = 6.7 (Pascarella et al., 2021). Z_α= The value for a type I error of 5% = 1.96 Z_β=The value for a type II error of 20% = 0.84 D^2= The effect size = 36 (Pascarella et al., 2021).
By calculation:
N = 19 per group. So, the total sample size is 38.
Procedures:
After getting the informed consent from the patient, the patient will be allocated into one of the study groups according to randomization.
ASA standard monitors will be attached to the patient, a wide pore cannula (18G) will be inserted then a premedication with 50 -100 mcg of fentanyl and 1-2 mg midazolam intravenously will be given.
PENG group: PENG block will done under complete aseptic condition with 20 ml 0.25% bupivacaine diluted with normal saline Control group: no block will be done. Both groups will be anesthetized using spinal anesthesia with Bupivacaine
Study Variables:
Independent variables: age, sex, weight, height, body mass index (BMI), elective or emergency surgery, duration of surgery, American Society of Anesthesiologists physical status classification (ASA score), occupation, fracture site, type of trauma, timing (operating room entry- PENG block time- start of spinal anesthesia- start of surgery- end of surgery ).
Dependent variables: Postoperative pain, adverse events, and postoperative motor assessment, hemodynamics, the first request of analgesia \& total analgesia required, adverse events such as nausea vomiting \& sedation, pain scores at preparation room, after PENG block, during sitting for spinal anesthesia, at end of the surgery, postoperative intervals(rest \& movement).
- Conditions
- Pain, Postoperative
- Being tested
- PENG Block
- Keywords
- PENG, Hip Joint Surgeries, postoperative analgesia
- 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
With the patient in the supine position, the ultrasound probe is placed on a transverse plane over the anterior superior iliac spine (ASIS). Once the ASIS is identified, the transducer is aligned with the pubic ramus and rotated at approximately 45 degrees, parallel to the inguinal crease. The transducer then slides medially along this axis until the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), and the psoas tendon is clearly identified, serving as anatomic landmarks. Sliding the probe distally or gently tilting the caudal will expose the head of the femur. Returning to the initial starting position, a standard 22 gauge spinal needle is inserted in-plane, from lateral to medial, in the plane between the psoas tendon and the pubic ramus. 20 ml 0.25% bupivacaine diluted with preservative free normal saline then deposited in this plane, lifting the psoas tendon. Care should be taken to avoid puncturing the psoas tendon.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients in this group will be operated under spinal anesthesia |
| PENG Group | Active comparator | Patients in this group will undergo PENG block guided by ultrasound then spinal anesthesia will performed Receives: Procedure: PENG Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of first request of analgesia in both groups
The time of first request of analgesia in both groups in minutes
Measured: 24 hours postoperative
Secondary outcomes (4)
Evaluate the morphine consumption over the first 24 hours.
total dose of morphine in the first hours after surgery
Measured: 24 hours postoperative
Evaluate the regaining of motor function of quadriceps muscle in both groups
Evaluate the motor function of quadriceps muscle by Medical research council (MRC) scale
Measured: 24 hours postoperative
The incidence of occurrence of side effects related to the technique and medications in both groups
Nausea, vomiting
Measured: 24 hours postoperative
difference in Visual Analogue Score (VAS) pain score in the first 24 hours postoperative between the two groups
VAS pain score from 0-10 while 0 means no pain and 10 means the worst pain, at preparation room, after PENG block, during sitting for spinal anesthesia, at end of surgery, postoperative intervals(rest \& movement).
Measured: first 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 posted22 Nov 2023
- Study start1 Jun 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiman Ahmad Al-Touny, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144931
- Sponsor's protocol ID
- 4972#
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pericapsular Nerve Group Block on The Duration of Post-Operative Analgesia Following Hip Joint Surgeries
- ClinicalTrials.gov ID
- NCT06144931
- Acronym / sponsor ID
- 4972#
- Conditions
- Pain, Postoperative
- Keywords
- PENG, Hip Joint Surgeries, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 22 Nov 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.
To study the efficacy of the PENG block on the duration of postoperative analgesia. There are two groups of patients, who are undergoing hip joint surgeries, one group (Control Group) will receive spinal anesthesia only while the other group (PENG Group) will receive PENG block before spinal anesthesia.
Detailed description
Research Question:
Is PENG block effective in prolonging the duration of postoperative analgesia when compared to patients undergoing spinal anesthesia only?
Research Hypothesis:
PENG block is effective in prolonging the duration of postoperative analgesia and reducing postoperative pain.
Aim:
To improve the outcome of hip joint surgeries by decreasing the postoperative pain and early mobilization by performing PENG block to patients undergoing hip joint surgeries.
Method of randomization:
This clinical trial will be randomized through computer software that generates random number table and patients will be allocated randomly to one of the two groups.
Sample size:
The sample size was determined by using the following equation:(Charan J et al. 2013) N =(2 δ^(2 ) 〖(Z_α+ Z_β)〗^2)/D^2 δ=Standard deviation of the outcome = 6.7 (Pascarella et al., 2021). Z_α= The value for a type I error of 5% = 1.96 Z_β=The value for a type II error of 20% = 0.84 D^2= The effect size = 36 (Pascarella et al., 2021).
By calculation:
N = 19 per group. So, the total sample size is 38.
Procedures:
After getting the informed consent from the patient, the patient will be allocated into one of the study groups according to randomization.
ASA standard monitors will be attached to the patient, a wide pore cannula (18G) will be inserted then a premedication with 50 -100 mcg of fentanyl and 1-2 mg midazolam intravenously will be given.
PENG group: PENG block will done under complete aseptic condition with 20 ml 0.25% bupivacaine diluted with normal saline Control group: no block will be done. Both groups will be anesthetized using spinal anesthesia with Bupivacaine
Study Variables:
Independent variables: age, sex, weight, height, body mass index (BMI), elective or emergency surgery, duration of surgery, American Society of Anesthesiologists physical status classification (ASA score), occupation, fracture site, type of trauma, timing (operating room entry- PENG block time- start of spinal anesthesia- start of surgery- end of surgery ).
Dependent variables: Postoperative pain, adverse events, and postoperative motor assessment, hemodynamics, the first request of analgesia \& total analgesia required, adverse events such as nausea vomiting \& sedation, pain scores at preparation room, after PENG block, during sitting for spinal anesthesia, at end of the surgery, postoperative intervals(rest \& movement).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients in this group will be operated under spinal anesthesia |
| PENG Group | Active comparator | Procedure: PENG BlockPatients in this group will undergo PENG block guided by ultrasound then spinal anesthesia will performed |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with hip fracture who will be subjected to surgical treatment
- ASA physical status 1, 2
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).
- Substance abuse and prolonged intake of sedative drugs.
- Morbid obese patients (BMI>35).
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 BlockWith the patient in the supine position, the ultrasound probe is placed on a transverse plane over the anterior superior iliac spine (ASIS). Once the ASIS is identified, the transducer is aligned with the pubic ramus and rotated at approximately 45 degrees, parallel to the inguinal crease. The transducer then slides medially along this axis until the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), and the psoas tendon is clearly identified, serving as anatomic landmarks. Sliding the probe distally or gently tilting the caudal will expose the head of the femur. Returning to the initial starting position, a standard 22 gauge spinal needle is inserted in-plane, from lateral to medial, in the plane between the psoas tendon and the pubic ramus. 20 ml 0.25% bupivacaine diluted with preservative free normal saline then deposited in this plane, lifting the psoas tendon. Care should be taken to avoid puncturing the psoas tendon. | Procedure or surgery | PENG Group |
Primary outcome
The time of first request of analgesia in both groups
Time frame: 24 hours postoperative
The time of first request of analgesia in both groups in minutes
4 secondary outcomes
Evaluate the morphine consumption over the first 24 hours.
Time frame: 24 hours postoperative
Evaluate the regaining of motor function of quadriceps muscle in both groups
Time frame: 24 hours postoperative
The incidence of occurrence of side effects related to the technique and medications in both groups
Time frame: 24 hours postoperative
difference in Visual Analogue Score (VAS) pain score in the first 24 hours postoperative between the two groups
Time frame: first 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG Block in people with Pain, Postoperative, run by Suez Canal 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 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 22 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of first request of analgesia in both groups (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 22 Nov 2023.