Pain, AcuteNCT04871061
Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients
A study testing PENG Block and Conventional opioid analgesia (Fentanyl) in people with Pain, Acute, run by Cigli Regional Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate of analgesic effects of pericapsullar nerve group block which is performed preoperatively to assist positioning patients for performance of spinal anesthesia. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- PENG Block and Conventional opioid analgesia (Fentanyl)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2021to 5 Jul 2021
- 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
- hip fracture
- aged between 35 and 90 years old
Who cannot join
- contraindications for spinal anesthesia and PENG block
- impaired cognition or dementia
- multiple fractures
- any previous analgesic administration during the last 12 hours
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate of analgesic effects of pericapsullar nerve group block which is performed preoperatively to assist positioning patients for performance of spinal anesthesia.
- Conditions
- Pain, Acute
- Being tested
- PENG Block, Conventional opioid analgesia (Fentanyl)
- Keywords
- hip fracture, postoperative analgesia, positioning pain
- Medical subject headings
- Acute Pain, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BlockProcedure or surgery
Pericapsular Nerve Group Block
Conventional opioid analgesia (Fentanyl)Drug
standardised intravenous opioid
| Study group | Role | What they receive |
|---|---|---|
| PENG Block | Active comparator | For patients with hip fracture and having hip surgery this study evaluates the analgesic effects of Pericapsular Nerve Group (PENG) block for positioning before spinal anesthesia. Receives: Procedure: PENG Block |
| Control | Active comparator | in this group, standardised opioid doses (drug: Fentanyl) will be used for analgesia for positioning pain Receives: Drug: Conventional opioid analgesia (Fentanyl) |
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: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
Secondary outcomes (3)
Duration of spinal anesthesia performance
It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal
Measured: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
Quality of patient's position
The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"
Measured: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start6 May 2021
- Primary completion1 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cigli Regional Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Aygün, Cigli Regional Training Hospital
- Investigators
- Hakan Aygun, MD, Study director, Cigli RTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871061
- Sponsor's protocol ID
- PENG55
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133.
PubMed 25068412Aygun H, Tulgar S, Yigit Y, Tasdemir A, Kurt C, Genc C, Bilgin S, Senoglu N, Koksal E. Effect of ultrasound-guided pericapsular nerve group (PENG) block on pain during patient positioning for central nervous blockade in hip surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Sep 15;23(1):316. doi: 10.1186/s12871-023-02245-3.
PubMed 37715173
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT04871061
- Acronym / sponsor ID
- PENG55
- Conditions
- Pain, Acute
- Keywords
- hip fracture, postoperative analgesia, positioning pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cigli Regional Training HospitalUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 4 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.
The purpose of this study is to evaluate of analgesic effects of pericapsullar nerve group block which is performed preoperatively to assist positioning patients for performance of spinal anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG Block | Active comparator | Procedure: PENG BlockFor patients with hip fracture and having hip surgery this study evaluates the analgesic effects of Pericapsular Nerve Group (PENG) block for positioning before spinal anesthesia. |
| Control | Active comparator | Drug: Conventional opioid analgesia (Fentanyl)in this group, standardised opioid doses (drug: Fentanyl) will be used for analgesia for positioning pain |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hip fracture
- aged between 35 and 90 years old
Key exclusion criteria (4 listed)
- contraindications for spinal anesthesia and PENG block
- impaired cognition or dementia
- multiple fractures
- any previous analgesic administration during the last 12 hours
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 BlockPericapsular Nerve Group Block | Procedure or surgery | PENG Block |
| Conventional opioid analgesia (Fentanyl)standardised intravenous opioid | Drug | Control |
Primary outcome
Pain scores on the Numeric Rating Scale (NRS)
Time frame: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 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").
3 secondary outcomes
Duration of spinal anesthesia performance
Time frame: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
Quality of patient's position
Time frame: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
Analgesic consumption
Time frame: 24 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 14 Apr 2022.
- Results publication: PubMed 25068412Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133.
- Derived from this study: PubMed 37715173Aygun H, Tulgar S, Yigit Y, Tasdemir A, Kurt C, Genc C, Bilgin S, Senoglu N, Koksal E. Effect of ultrasound-guided pericapsular nerve group (PENG) block on pain during patient positioning for central nervous blockade in hip surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Sep 15;23(1):316. doi: 10.1186/s12871-023-02245-3.
Related trials for Pain, Acute
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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.
Hakan Aygun, MD study director
Cigli RTH
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 and Conventional opioid analgesia (Fentanyl) in people with Pain, Acute, run by Cigli Regional Training Hospital 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 2 inclusion and 4 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 14 Apr 2022. 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: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 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 NCT04871061, which also lists 2 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 14 Apr 2022.