Hip FracturesNCT06169462
Comparison of Pericapsular Nerve Group Block With Suprainguinal Fascia Compartment Block in Hip Fractures
An observational study of Hip Fractures, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Ultrasound-guided Supra-inguinal Fascia Iliaca compartment Block (SIFCB) and Pericapsular Nerve Group Block (PENG) are increasingly being used for postoperative analgesia for hip surgery. The postoperative analgesic efficacy of SIFCB added to PENG block in elderly hip fracture patients will be evaluated. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures
- What is being tested?
- PENG block and PENG block+ SIFCB
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2023to 10 Dec 2023
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Data of patients underwent hip surgery under spinal anesthesia between 31.01.2023 and 01.10.2023.
Who may be able to join
- Physical status according to American Society of Anesthesiologists (ASA ) I-III
Who cannot join
- Previous operation on the same hip
- Hepatic or renal insufficiency
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- BMI >40
- ASA IV
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, Karaman/Merkez, 70200
About this study
Official title: Comparison of Pericapsular Nerve Group (PENG) Block Alone Versus Combined With Suprainguinal Fascia Compartment Block (SIFCB) for Postoperative Analgesia and Quality of Recovery in Older Adult Patients With Hip Fractures
Ultrasound-guided Supra-inguinal Fascia Iliaca compartment Block (SIFCB) and Pericapsular Nerve Group Block (PENG) are increasingly being used for postoperative analgesia for hip surgery. The postoperative analgesic efficacy of SIFCB added to PENG block in elderly hip fracture patients will be evaluated. Postoperative opioid consumption and quality of recovery will also be evaluated.
Read the detailed description
The study was conducted as a retrospective cohort feasibility design within a tertiary hospital. Patient records and electronic data systems were used to gather the required data for analysis. Before surgery, a carefully selected cohort of patients who underwent PENG block and PENG block added SIFCB were included in the study.
- Conditions
- Hip Fractures
- Being tested
- PENG block, PENG block+ SIFCB
- Keywords
- Anesthesia, Lower extremity, pericapsular nerve group block, suprainguinal fascia compartment block
- Medical subject headings
- 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
Also called Drug
Patients underwent ultrasound-guided PENG Block for older adult patients surgery for hip fracture. Patients who received opioids as a rescue analgesic during postoperative pain management on selected dates will be included in the study.
PENG block+ SIFCBProcedure or surgery
Also called Drug
Patients underwent ultrasound-guided PENG Block+ SIFCB for older adult patients surgery for hip fracture. Patients who received opioids as a rescue analgesic during postoperative pain management on selected dates will be included in the study.
| Study group | Role | What they receive |
|---|---|---|
| Pericapsular nerve group (PENG) block | Patients who underwent PENG in Hip surgery under spinal anesthesia will be evaluated retrospectively in terms of opioid consumption and NRS scores. Receives: Procedure: PENG block | |
| Suprainguinal fascia compartment block (SIFCB) + PENG | Patients who underwent PENG+SIFCB in Hip surgery under spinal anesthesia will be evaluated retrospectively in terms of opioid consumption and NRS scores. Receives: Procedure: PENG block+ SIFCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
If the patient's Numerical Rating Scale (NRS) score is equal to or above 4, tramadol 50 mg IV or oxycodone 5 mg orally every 4 hours will be administered as rescue analgesia.
Measured: Postoperative 48th hour
Secondary outcomes (4)
Numerical Rating Scale (NRS) scores
Range 0-10, 0=no pain, 10=the worse pain ever
Measured: Postoperative 48th hour
Quality of Recovery 15 Score
Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better
Measured: Postoperative day 1 and 1 month
Postoperative complications
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression
Measured: 24 hours
Mobilization time
Mobilization time
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 posted13 Dec 2023
- Study start31 Jan 2023
- Primary completion1 Sep 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169462
- Sponsor's protocol ID
- 10-2023/17
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pericapsular Nerve Group (PENG) Block Alone Versus Combined With Suprainguinal Fascia Compartment Block (SIFCB) for Postoperative Analgesia and Quality of Recovery in Older Adult Patients With Hip Fractures
- ClinicalTrials.gov ID
- NCT06169462
- Acronym / sponsor ID
- 10-2023/17
- Conditions
- Hip Fractures
- Keywords
- Anesthesia, Lower extremity, pericapsular nerve group block, suprainguinal fascia compartment block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 13 Dec 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.
Ultrasound-guided Supra-inguinal Fascia Iliaca compartment Block (SIFCB) and Pericapsular Nerve Group Block (PENG) are increasingly being used for postoperative analgesia for hip surgery. The postoperative analgesic efficacy of SIFCB added to PENG block in elderly hip fracture patients will be evaluated. Postoperative opioid consumption and quality of recovery will also be evaluated.
Detailed description
The study was conducted as a retrospective cohort feasibility design within a tertiary hospital. Patient records and electronic data systems were used to gather the required data for analysis. Before surgery, a carefully selected cohort of patients who underwent PENG block and PENG block added SIFCB were included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pericapsular nerve group (PENG) block | – | Procedure: PENG blockPatients who underwent PENG in Hip surgery under spinal anesthesia will be evaluated retrospectively in terms of opioid consumption and NRS scores. |
| Suprainguinal fascia compartment block (SIFCB) + PENG | – | Procedure: PENG block+ SIFCBPatients who underwent PENG+SIFCB in Hip surgery under spinal anesthesia will be evaluated retrospectively in terms of opioid consumption and NRS scores. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Data of patients underwent hip surgery under spinal anesthesia between 31.01.2023 and 01.10.2023.
Key inclusion criteria (1 listed)
- Physical status according to American Society of Anesthesiologists (ASA ) I-III
Key exclusion criteria (6 listed)
- Previous operation on the same hip
- Hepatic or renal insufficiency
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- BMI >40
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 blockAlso: DrugPatients underwent ultrasound-guided PENG Block for older adult patients surgery for hip fracture. Patients who received opioids as a rescue analgesic during postoperative pain management on selected dates will be included in the study. | Procedure or surgery | Pericapsular nerve group (PENG) block |
| PENG block+ SIFCBAlso: DrugPatients underwent ultrasound-guided PENG Block+ SIFCB for older adult patients surgery for hip fracture. Patients who received opioids as a rescue analgesic during postoperative pain management on selected dates will be included in the study. | Procedure or surgery | Suprainguinal fascia compartment block (SIFCB) + PENG |
Primary outcome
Opioid consumption
Time frame: Postoperative 48th hour
If the patient's Numerical Rating Scale (NRS) score is equal to or above 4, tramadol 50 mg IV or oxycodone 5 mg orally every 4 hours will be administered as rescue analgesia.
4 secondary outcomes
Numerical Rating Scale (NRS) scores
Time frame: Postoperative 48th hour
Quality of Recovery 15 Score
Time frame: Postoperative day 1 and 1 month
Postoperative complications
Time frame: 24 hours
Mobilization time
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 Dec 2023.
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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.
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?
An observational study of Hip Fractures, run by Karaman 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 1 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: finished, as of the sponsor's last update on 14 Dec 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 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?
Opioid consumption (time frame: Postoperative 48th hour). 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 14 Dec 2023.