Hip FractureNCT06389279
The Effect of Facial Plane Blocks on Postoperative Recovery Quality in Hip Surgery
An observational study of Hip Fracture, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effect of ultrasound-guided pericapsular nerve block, fascia iliaca compartment block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip Fracture
- What is being tested?
- PENG block group, FIC block group and Femoral block group
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2024to 24 Oct 2024
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It is planned to include ASA I-III patients between the ages of 1-85 who are planned to undergo hip fracture surgery under elective spinal anesthesia.
Who may be able to join
- elective hip fracture,
- 18-85 years
- American Society of Anaesthesiology (ASA) I-III
Who cannot join
- patients planned for general anesthesia
- with multiple fractures
- bleeding disorder
- peripheral neuropathy
- mental disorder
- local anesthetic allergy
- contraindications for spinal anesthesia (local infection, etc.)
- declining to give written informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences, Antalya Training and Researh Hospital
Antalya
Antalya Training and Research Hospital
About this study
Official title: The Effect of Ultrasound-guided Pericapsular Nerve Block, Fascia Iliaca Compartment Block and Femoral Block on Postoperative Recovery Quality in Hip Surgery
The aim of this study was to evaluate the effect of ultrasound-guided pericapsular nerve block, fascia iliaca compartment block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia.
Read the detailed description
Orthopedic procedures have become increasingly common in clinical practice. With the increasing elderly population, there have been significant developments in recent years in the field of perioperative pain management and anesthesia strategies for patients scheduled for hip surgery. Patients undergoing hip surgery may experience severe pain both postoperatively and during the positioning of the patient during surgery. This leads to increased sympathetic activation such as tachycardia and hypertension in patients, especially in the elderly population, and some undesirable complications due to the patients' existing comorbidities. Therefore, pain management strategies for patients undergoing hip surgery are based on a range of anesthesia techniques, including the use of opioids, neuraxial anesthesia (spinal, epidural, or a combination of them), nerve blocks, especially pericapsular nerve block (PENG), fascia iliaca compartment block (FICB) and femoral block). Reducing patients' pain and improving the quality of postoperative recovery has become increasingly important. The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess postoperative recovery. This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the early postoperative period. The aim of this study was to evaluate the effect of ultrasound-guided PENG block, FICB block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia.
- Conditions
- Hip Fracture
- Being tested
- PENG block group, FIC block group, Femoral block group, Control group
- Keywords
- regional anesthesia, postoperative pain, recovery quality, hip fracture
- Medical subject headings
- Hip Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG block groupOther
Ultrasound-guided PENG block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring.
FIC block groupOther
Ultrasound-guided FIC block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring.
Femoral block groupOther
Ultrasound-guided femoral block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring.
Control groupOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| PENG block group | Before the spinal anesthesia, PENG block will be performed under the guidance of ultrasound. Receives: Other: PENG block group | |
| FIC block group | Before the spinal anesthesia, FIC block will be performed under the guidance of ultrasound. Receives: Other: FIC block group | |
| Femoral block group | Before the spinal anesthesia, femoral block will be performed under the guidance of ultrasound. Receives: Other: Femoral block group | |
| Control group | No intervention Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
recovery quality
The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess postoperative recovery. This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the early postoperative period. The patient is asked to express their status scoring from 0 to 10; therefore, the total score ranges from 0 to 150 points,
Measured: 5 minutes
Secondary outcomes (2)
postoperative Numeric Rating Scale (NRS) pain score
The postoperative pain intensity will be assessed with Numeric Rating Scale (NRS) scores (0 represents no pain and 10 represents the worst possible pain) at postoperative 24 hours.
Measured: postoperative 24 hours
postoperative opioid consumption
The amount of postoperative opioid consumption will be recorded
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start30 Apr 2024
- Primary completion24 Sep 2024 (estimated)
- Study completion24 Oct 2024 (estimated)
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 Hip FractureStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Arzu Karaveli, M.D., Principal investigator, University of Health Sciences, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389279
- Sponsor's protocol ID
- 2023-18/11
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalashetty MB, Channappagoudar R, Alwandikar V, Naik DL, Hulakund SY, Guddad A. Comparison of Pericapsular Nerve Group Block with Fascia Iliaca Compartment Block in Adult Patients Undergoing Hip Surgeries: A Double-Blinded Randomized Control Study. Anesth Essays Res. 2022 Jul-Sep;16(3):397-401. doi: 10.4103/aer.aer_123_22. Epub 2022 Dec 9.
PubMed 36620112Kukreja P, Uppal V, Kofskey AM, Feinstein J, Northern T, Davis C, Morgan CJ, Kalagara H. Quality of recovery after pericapsular nerve group (PENG) block for primary total hip arthroplasty under spinal anaesthesia: a randomised controlled observer-blinded trial. Br J Anaesth. 2023 Jun;130(6):773-779. doi: 10.1016/j.bja.2023.02.017. Epub 2023 Mar 22.
PubMed 36964012
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-guided Pericapsular Nerve Block, Fascia Iliaca Compartment Block and Femoral Block on Postoperative Recovery Quality in Hip Surgery
- ClinicalTrials.gov ID
- NCT06389279
- Acronym / sponsor ID
- 2023-18/11
- Conditions
- Hip Fracture
- Keywords
- regional anesthesia, postoperative pain, recovery quality, hip fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 24 Sep 2024 (estimated)
- Study completion
- 24 Oct 2024 (estimated)
- First posted
- 29 Apr 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 aim of this study was to evaluate the effect of ultrasound-guided pericapsular nerve block, fascia iliaca compartment block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia.
Detailed description
Orthopedic procedures have become increasingly common in clinical practice. With the increasing elderly population, there have been significant developments in recent years in the field of perioperative pain management and anesthesia strategies for patients scheduled for hip surgery. Patients undergoing hip surgery may experience severe pain both postoperatively and during the positioning of the patient during surgery. This leads to increased sympathetic activation such as tachycardia and hypertension in patients, especially in the elderly population, and some undesirable complications due to the patients' existing comorbidities. Therefore, pain management strategies for patients undergoing hip surgery are based on a range of anesthesia techniques, including the use of opioids, neuraxial anesthesia (spinal, epidural, or a combination of them), nerve blocks, especially pericapsular nerve block (PENG), fascia iliaca compartment block (FICB) and femoral block). Reducing patients' pain and improving the quality of postoperative recovery has become increasingly important. The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess postoperative recovery. This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the early postoperative period. The aim of this study was to evaluate the effect of ultrasound-guided PENG block, FICB block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PENG block group | – | Other: PENG block groupBefore the spinal anesthesia, PENG block will be performed under the guidance of ultrasound. |
| FIC block group | – | Other: FIC block groupBefore the spinal anesthesia, FIC block will be performed under the guidance of ultrasound. |
| Femoral block group | – | Other: Femoral block groupBefore the spinal anesthesia, femoral block will be performed under the guidance of ultrasound. |
| Control group | – | Other: Control groupNo intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to include ASA I-III patients between the ages of 1-85 who are planned to undergo hip fracture surgery under elective spinal anesthesia.
Key inclusion criteria (3 listed)
- elective hip fracture,
- 18-85 years
- American Society of Anaesthesiology (ASA) I-III
Key exclusion criteria (8 listed)
- patients planned for general anesthesia
- with multiple fractures
- bleeding disorder
- peripheral neuropathy
- mental disorder
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 block groupUltrasound-guided PENG block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring. | Other | PENG block group |
| FIC block groupUltrasound-guided FIC block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring. | Other | FIC block group |
| Femoral block groupUltrasound-guided femoral block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring. | Other | Femoral block group |
| Control groupNo intervention | Other | Control group |
Primary outcome
recovery quality
Time frame: 5 minutes
The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess postoperative recovery. This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the early postoperative period. The patient is asked to express their status scoring from 0 to 10; therefore, the total score ranges from 0 to 150 points,
2 secondary outcomes
postoperative Numeric Rating Scale (NRS) pain score
Time frame: postoperative 24 hours
postoperative opioid consumption
Time frame: postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 36620112Kalashetty MB, Channappagoudar R, Alwandikar V, Naik DL, Hulakund SY, Guddad A. Comparison of Pericapsular Nerve Group Block with Fascia Iliaca Compartment Block in Adult Patients Undergoing Hip Surgeries: A Double-Blinded Randomized Control Study. Anesth Essays Res. 2022 Jul-Sep;16(3):397-401. doi: 10.4103/aer.aer_123_22. Epub 2022 Dec 9.
- Background: PubMed 36964012Kukreja P, Uppal V, Kofskey AM, Feinstein J, Northern T, Davis C, Morgan CJ, Kalagara H. Quality of recovery after pericapsular nerve group (PENG) block for primary total hip arthroplasty under spinal anaesthesia: a randomised controlled observer-blinded trial. Br J Anaesth. 2023 Jun;130(6):773-779. doi: 10.1016/j.bja.2023.02.017. Epub 2023 Mar 22.
- Individual participant dataSharing planned: No
Related trials for Hip Fracture
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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.
Arzu Karaveli, M.D. principal investigator
University of Health Sciences, Antalya 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?
An observational study of Hip Fracture, run by Antalya Training and Research 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 3 inclusion and 8 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 1 May 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?
Contact Arzu Karaveli (+ 90 2422494400, arzukaraveli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recovery quality (time frame: 5 minutes). 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 NCT06389279, 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 1 May 2024.