Pain, PostoperativeNCT06226675
'The Effect of Adding LFCN Block to PENG
A study testing PENG Block and LFCN block in people with Pain, Postoperative and Pain, Acute, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The incidence of femoral neck fracture in Europe is 330/10000 per year. It is increasing every year due to the aging of the population. In patients 55 years and older, hip fracture-related mortality is estimated to be between 4% and 16% at one month and between 11% and 43% at one year after surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Pain, Acute, Nerve Block
- What is being tested?
- PENG Block and LFCN block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Apr 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years old,
- ASA I-II-III risk group
- patients undergoing hip fracture surgery under spinal anesthesia
- Patients whose informed consent was read and consent was obtained from them and their representatives.
Who cannot join
- Those who do not want to participate in the study,
- ASA IV-V patients
- Those with coagulation disorders
- Allergic to local anesthetics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University
Zonguldak, Kozlu, 67600
About this study
Official title: The Effect of Adding Lateral Femoral Cutaneous Nerve Block to PENG Block on Postoperative Opioid Consumption in Hip Surgery
The incidence of femoral neck fracture in Europe is 330/10000 per year. It is increasing every year due to the aging of the population. In patients 55 years and older, hip fracture-related mortality is estimated to be between 4% and 16% at one month and between 11% and 43% at one year after surgery. The reduced risk of postoperative complications associated with the use of regional anesthesia, shorter mobilization times, and reduced morphine consumption in hip fractures have been reported, and have been incorporated into postoperative pain control as part of multimodal strategies. PENG has been described for postoperative pain control for surgery on the hip joint or for the treatment of post-traumatic pain associated with proximal femur/femoral head fractures. Lateral femoral cutaneous nerve block is used in combination with other peripheral block methods to provide analgesia in the lateral thigh.
The investigators aimed to evaluate the effect of adding lateral femoral cutaneous nerve block to PENG block on pain scores and opioid consumption in femoral fracture procedures under spinal anesthesia.
- Conditions
- Pain, Postoperative, Pain, Acute, Nerve Block, Opioid Consumption
- Being tested
- PENG Block, LFCN block
- Keywords
- lateral femoral cutaneous nerve block, PENG block, Pain management, Opioid consumption
- Medical subject headings
- Pain, Postoperative, Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BlockProcedure or surgery
To apply local anesthetic under psoas tendon
LFCN blockProcedure or surgery
to apply local anesthetic around lateral femoral cutaneous nerve
| Study group | Role | What they receive |
|---|---|---|
| Group Control | No intervention | Not described |
| Group PENG | Active comparator | Not described Receives: Procedure: PENG Block |
| Group PENG+LFCN | Active comparator | Not described Receives: Procedure: PENG Block; Procedure: LFCN block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption
total morphine requirement
Measured: up to 24 hour after surgery
Secondary outcomes (4)
pain scores
evaluating pain scores by Numeric Rating Score
Measured: up to 24 hour after surgery
first analgesic time
the need of first analgesic after surgery
Measured: up to 24 hour after surgery
postoperative complications
nausea-vomitting, motor block, hypertension, hypotension etc.
Measured: up to 24 hour after surgery
mobilization time
when the patient is first mobilized
Measured: up to 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Jan 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion1 Apr 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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keziban Bollucuoglu, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226675
- Sponsor's protocol ID
- 2020/15-14
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Lateral Femoral Cutaneous Nerve Block to PENG Block on Postoperative Opioid Consumption in Hip Surgery
- ClinicalTrials.gov ID
- NCT06226675
- Acronym / sponsor ID
- 2020/15-14
- Conditions
- Pain, Postoperative, Pain, Acute, Nerve Block, Opioid Consumption
- Keywords
- lateral femoral cutaneous nerve block, PENG block, Pain management, Opioid consumption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 26 Jan 2024 (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 incidence of femoral neck fracture in Europe is 330/10000 per year. It is increasing every year due to the aging of the population. In patients 55 years and older, hip fracture-related mortality is estimated to be between 4% and 16% at one month and between 11% and 43% at one year after surgery. The reduced risk of postoperative complications associated with the use of regional anesthesia, shorter mobilization times, and reduced morphine consumption in hip fractures have been reported, and have been incorporated into postoperative pain control as part of multimodal strategies. PENG has been described for postoperative pain control for surgery on the hip joint or for the treatment of post-traumatic pain associated with proximal femur/femoral head fractures. Lateral femoral cutaneous nerve block is used in combination with other peripheral block methods to provide analgesia in the lateral thigh.
The investigators aimed to evaluate the effect of adding lateral femoral cutaneous nerve block to PENG block on pain scores and opioid consumption in femoral fracture procedures under spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Control | No intervention | – |
| Group PENG | Active comparator | Procedure: PENG Block |
| Group PENG+LFCN | Active comparator | Procedure: PENG Block, Procedure: LFCN block |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years old,
- ASA I-II-III risk group
- patients undergoing hip fracture surgery under spinal anesthesia
- Patients whose informed consent was read and consent was obtained from them and their representatives.
Key exclusion criteria (4 listed)
- Those who do not want to participate in the study,
- ASA IV-V patients
- Those with coagulation disorders
- Allergic to local anesthetics
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 BlockTo apply local anesthetic under psoas tendon | Procedure or surgery | Group PENG, Group PENG+LFCN |
| LFCN blockto apply local anesthetic around lateral femoral cutaneous nerve | Procedure or surgery | Group PENG+LFCN |
Primary outcome
postoperative opioid consumption
Time frame: up to 24 hour after surgery
total morphine requirement
4 secondary outcomes
pain scores
Time frame: up to 24 hour after surgery
first analgesic time
Time frame: up to 24 hour after surgery
postoperative complications
Time frame: up to 24 hour after surgery
mobilization time
Time frame: up to 24 hour after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
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 study testing PENG Block and LFCN block in people with Pain, Postoperative and Pain, Acute, run by Zonguldak Bulent Ecevit 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 4 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: status not confirmed, as of the sponsor's last update on 26 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?
Results are not available in the source record.
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 opioid consumption (time frame: up to 24 hour after surgery). 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 Jan 2024; AzTrials last refreshed its copy on 30 Oct 2026.