Pain, AcuteNCT05358587
PENG Block With Two Diffirent Volume
A study testing Ultrasound guided PENG block with 20 mL Local Anesthetic solution and Ultrasound guided PENG block with 30 mL Local Anesthetic solution in people with Pain, Acute and Postoperative Pain, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Pain, Acute, Postoperative Pain, Hip Fractures
- What is being tested?
- Ultrasound guided PENG block with 20 mL Local Anesthetic solution and Ultrasound guided PENG block with 30 mL Local Anesthetic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2022to 4 Jan 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for total hip replacement surgery under spinal anesthesia
- ASA(American Society of Anesthesiology) 1-3
- Receiving consent that accept regional analgesia
Who cannot join
- contraindications for spinal anesthesia and PENG block
- impaired cognition or dementia
- multiple fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Perioperative Analgesic Efficacy of PENG Block Applications With Two Different Volumes in Patients Undergoing Hip Surgery
Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.
Read the detailed description
Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.
60 ASA I-III patients between 35-90 years of age who will be operated for femoral head/neck fractures will be included in the study. US-guided block procedure will be applied 30 minutes before the start of surgery. The patients will be divided into two groups, Group I, PENG block 20ml bupivacaine (n:30) and Group II, PENG block 30ml bupivacaine (n:30) using the closed envelope method in the operating room. Randomization will be performed by one of the researchers for each patient. Randomization information of patients will be used for all follow-up and data collection. The anesthetist applying the block will not take any part in collecting the data or performing the analysis. Numerical rating scale (NRS) will be used to evaluate pain. Patients will be given spinal anesthesia 30 minutes after PENG block. The primary outcome measure was determined as pain during positioning. NRS scores will be recorded after entering the operating room before, immediately before, during, and immediately after any analgesic intervention. Secondary outcome measures will be determined as the time required for LA performance (measured from the start of the position maneuvers to removal of the spinal needle), the quality of the patient position for LA performance ("unsatisfactory", "satisfactory", "good", "very good" to define SA). Questionnary 15 test will be applied to the patients 24 hours after the operation to measure patient satisfaction and to measure patient satisfaction.
- Conditions
- Pain, Acute, Postoperative Pain, Hip Fractures
- Being tested
- Ultrasound guided PENG block with 20 mL Local Anesthetic solution, Ultrasound guided PENG block with 30 mL Local Anesthetic solution
- Medical subject headings
- Acute Pain, Pain, Postoperative, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided PENG block with 20 mL Local Anesthetic solutionOther
In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %). Block will be performed 30 minutes before spinal anesthesia.
Ultrasound guided PENG block with 30 mL Local Anesthetic solutionOther
In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %). Block will be performed 30 minutes before spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| PENG (20 mL) | Experimental | In this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %) Receives: Other: Ultrasound guided PENG block with 20 mL Local Anesthetic solution |
| PENG (30 mL) | Experimental | In this group, US guided PENG block will be performed with 30 ml of Bupivacaine solution (0.25 %) Receives: Other: Ultrasound guided PENG block with 30 mL Local Anesthetic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores on the Numeric Rating Scale (NRS)
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 30 minutes after intervention (PENG block) ]
Secondary outcomes (5)
Duration of spinal anesthesia performance
It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal
Measured: up to ten minutes
Quality of patient's position
The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"
Measured: up to ten minutes
analgesic consumption
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.
Measured: 24 hours
Quality of recovery 15 scale
Postoperative Quality of Recovery 15 in Turkish scale
Measured: 24 hours after surgery
Quadriceps weakness
Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Measured: postoperative 6th and 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start9 May 2022
- Primary completion29 Dec 2023
- Study completion4 Jan 2024
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 Pain, AcuteStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Ertas, Samsun University
- Investigators
- Gamze Ertas, specialist, Principal investigator, samsun university, samsun training and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358587
- Sponsor's protocol ID
- PENG_55
- Status last verified
- Jan 2024
- First submitted
- 20 Apr 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6.
PubMed 34873023
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Perioperative Analgesic Efficacy of PENG Block Applications With Two Different Volumes in Patients Undergoing Hip Surgery
- ClinicalTrials.gov ID
- NCT05358587
- Acronym / sponsor ID
- PENG_55
- Conditions
- Pain, Acute, Postoperative Pain, Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 3 May 2022 (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.
Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.
Detailed description
Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.
60 ASA I-III patients between 35-90 years of age who will be operated for femoral head/neck fractures will be included in the study. US-guided block procedure will be applied 30 minutes before the start of surgery. The patients will be divided into two groups, Group I, PENG block 20ml bupivacaine (n:30) and Group II, PENG block 30ml bupivacaine (n:30) using the closed envelope method in the operating room. Randomization will be performed by one of the researchers for each patient. Randomization information of patients will be used for all follow-up and data collection. The anesthetist applying the block will not take any part in collecting the data or performing the analysis. Numerical rating scale (NRS) will be used to evaluate pain. Patients will be given spinal anesthesia 30 minutes after PENG block. The primary outcome measure was determined as pain during positioning. NRS scores will be recorded after entering the operating room before, immediately before, during, and immediately after any analgesic intervention. Secondary outcome measures will be determined as the time required for LA performance (measured from the start of the position maneuvers to removal of the spinal needle), the quality of the patient position for LA performance ("unsatisfactory", "satisfactory", "good", "very good" to define SA). Questionnary 15 test will be applied to the patients 24 hours after the operation to measure patient satisfaction and to measure patient satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG (20 mL) | Experimental | Other: Ultrasound guided PENG block with 20 mL Local Anesthetic solutionIn this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %) |
| PENG (30 mL) | Experimental | Other: Ultrasound guided PENG block with 30 mL Local Anesthetic solutionIn this group, US guided PENG block will be performed with 30 ml of Bupivacaine solution (0.25 %) |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for total hip replacement surgery under spinal anesthesia
- ASA(American Society of Anesthesiology) 1-3
- Receiving consent that accept regional analgesia
Key exclusion criteria (3 listed)
- contraindications for spinal anesthesia and PENG block
- impaired cognition or dementia
- multiple fractures
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 PENG block with 20 mL Local Anesthetic solutionIn this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %). Block will be performed 30 minutes before spinal anesthesia. | Other | PENG (20 mL) |
| Ultrasound guided PENG block with 30 mL Local Anesthetic solutionIn this group, US guided PENG block will be performed with 20 ml of Bupivacaine solution (0.25 %). Block will be performed 30 minutes before spinal anesthesia. | Other | PENG (30 mL) |
Primary outcome
Pain scores on the Numeric Rating Scale (NRS)
Time frame: 30 minutes after intervention (PENG block) ]
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
5 secondary outcomes
Duration of spinal anesthesia performance
Time frame: up to ten minutes
Quality of patient's position
Time frame: up to ten minutes
analgesic consumption
Time frame: 24 hours
Quality of recovery 15 scale
Time frame: 24 hours after surgery
Quadriceps weakness
Time frame: postoperative 6th and 24th hours
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 5 Jan 2024.
- Results publication: PubMed 34873023Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6.
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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.
Gamze Ertas, specialist principal investigator
samsun university, samsun training and research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided PENG block with 20 mL Local Anesthetic solution and Ultrasound guided PENG block with 30 mL Local Anesthetic solution in people with Pain, Acute and Postoperative Pain, run by Samsun University at 1 site in Turkey (Türkiye).
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 3 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 5 Jan 2024. 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 Turkey (Türkiye). 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?
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?
Pain scores on the Numeric Rating Scale (NRS) (time frame: 30 minutes after intervention (PENG block) ]). 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 NCT05358587, 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 5 Jan 2024.