Post Operative PainQoR-15NCT05965544
The Effect of Fascia Iliaca Compartment Block (FICB) on QoR-15 Score in Partial Hip Arthroplasty Surgery
A study testing Bupivacain (preoperative), Bupivacaine-fentanyl and Bupivacain (Postoperative) in people with Post Operative Pain and Anesthesia, Local, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
It reduces pain scores in patients with block and improves the quality of recovery in the postoperative period. In patients who will undergo spinal anesthesia, it will be questioned whether the application of the block before or after surgery makes a difference in the quality of recovery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Post Operative Pain, Anesthesia, Local, Fracture of Hip
- What is being tested?
- Bupivacain (preoperative), Bupivacaine-fentanyl and Bupivacain (Postoperative)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2023to 14 May 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Partial Hip Arthroplasty
- American Society of Anesthesiologists (ASA) physical status I-III,
- Patients aged ≥ 65 years
Who cannot join
- Contraindication for central or peripheral blocks,
- Cognitive Dysfunction,
- History of chronic opioid use,
- Previous hip surgery,
- Serious organ dysfunction,
- Allergy to any drug used in the study,
Show all 9Show fewer
- Body mass index (BMI) ≥30,
- Infection in the area to be treated,
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Application of Fascia Iliaca Compartment Block (FICB) Before or After Spinal Anesthesia on QoR-15 Score in Partial Hip Arthroplasty Surgery
It reduces pain scores in patients with block and improves the quality of recovery in the postoperative period. In patients who will undergo spinal anesthesia, it will be questioned whether the application of the block before or after surgery makes a difference in the quality of recovery.
Read the detailed description
American Society of Anesthesiologists (ASA) physical status I-III patients who are planned for partial hip arthroplasty will be studied in patients over 65 years of age. The patients will be equally randomized into two groups using a computer-generated random number table. In the preoperative period, according to whether FIBP was before or after spinal anesthesia, it will be named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal). The patient will be placed in the lateral decubitus position with the fractured side up. After the spinal anesthesia method was provided with aseptic conditions, 10 mg 0.5% isobaric bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle through the L3-L4 or L4-L5 intervertebral space. After the patients are in the supine position and aseptic conditions are provided, the fascia on the Iliacus muscle will be determined with the help of an 8-12 MHz linear probe, and the block will be applied with the in-plane technique. During the block, patients will routinely administer 0.2% bupivacaine concentration of 0.5 mL/kg. Demographic data, operation time, perioperative analgesic and sedation need, postoperative pain scores, additional analgesic need, hospitalization and 24th-hour recovery scores will be evaluated.
- Conditions
- Post Operative Pain, Anesthesia, Local, Fracture of Hip, QoR-15
- Being tested
- Bupivacain (preoperative), Bupivacaine-fentanyl, Bupivacain (Postoperative)
- Keywords
- Fascia Iliaca Compartment Block, FICB, Partial Hip Arthroplasty Surgery, Quality of Recovery-15
- Medical subject headings
- Pain, Postoperative, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacain (preoperative)Drug
Also called Preoperative Fascia Iliaca Compartment Block
After the patients are in the supine position and aseptic conditions are provided in the preoperative period, the fascia on the iliacus muscle will be determined with the help of an 8-12 MHz linear probe and a block will be applied with the in-plane technique. During the block, 0.2% bupivacaine concentration 0.5 mL/kg is routinely used in patients.
Bupivacaine-fentanylDrug
Also called Spinal Anesthesia
The patient will be placed in the lateral decubitus position with the fractured side up. After the spinal anesthesia method was provided with aseptic conditions, 10 mg 0.5% bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle through the L3-L4 or L4-L5 intervertebral space
Bupivacain (Postoperative)Drug
Also called Postoperative Fascia Iliaca Compartment Block
After the patients are in the supine position and aseptic conditions are provided in the postoperative period, the fascia on the iliacus muscle will be determined with the help of an 8-12 MHz linear probe and a block will be applied with the in-plane technique. During the block, 0.2% bupivacaine concentration 0.5 mL/kg is routinely used in patients.
| Study group | Role | What they receive |
|---|---|---|
| Group PreS | Active comparator | The block will be applied in the preoperative period Receives: Drug: Bupivacain (preoperative); Drug: Bupivacaine-fentanyl |
| Group PostS | Active comparator | The block will be applied in the postoperative period Receives: Drug: Bupivacaine-fentanyl; Drug: Bupivacain (Postoperative) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline QoR-15 at 24 hours postoperatively
The patient-reported Turkish QoR-15 score includes 15 questions that evaluate the patient's postoperative recovery. The QoR-15 score is grouped under two groups, A and B. A high QoR-15 score, a score between 0 (poor) and 10 (excellent) for each item, and a total score of 150 indicate better quality of recovery.
Measured: Postoperative 24th-hours
Secondary outcomes (3)
Change from baseline Nursing Delirium Screening Scale (N-DSS) at 24 hours postoperatively
Postoperative delirium will be determined with the Nursing Delirium Screening Scale (N-DSS), an easily applicable five-item screening tool that evaluates disorientation, inappropriate behavior, inappropriate communication, hallucination, and psychomotor retardation. Each item scores between 0 and 2 and the total score varies between 0 and 10.
Measured: Postoperative 24th-hours
Postoperative nausea and vomiting
The frequency of nausea and vomiting in the postoperative period was calculated according to the Numeric Rank Score (NRS), which ranged from 0 to 3. Nausea-vomiting status of the patients: 0 points if there is no nausea and vomiting; 1 point if there is nausea, no vomiting; It is scored as 2 points if there is vomiting once and 3 points if there are two or more vomiting attacks.
Measured: Postoperative 24th hour
Analgesic consumption
The value in mg of the amount of analgesic consumed in the postoperative period
Measured: Postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start2 Aug 2023
- Primary completion14 May 2024
- Study completion14 May 2024
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 Post Operative PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients were equally randomized into two groups using a computer-generated random number table. In the preoperative period, according to whether FIBP was before or after spinal anesthesia, it was named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal).
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ergün Mendeş, Başakşehir Çam & Sakura City Hospital
- Investigators
- Ergun Mendes, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965544
- Sponsor's protocol ID
- e.mendes - 2
- Other IDs
- KAEK/2023.06.259
- Acronym
- QoR-15
- Status last verified
- May 2024
- First submitted
- 13 Jul 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Publications
Selvi O, Azizoglu M, Temel G, Tulgar S, Chitneni A, Cinar EN, Ozer Z, Gurkan Y. Translation and Validation of the Turkish Version of the Quality of Postoperative Recovery Score QoR-15: A Multi-Centred Cohort Study. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):443-448. doi: 10.5152/TJAR.2022.21417.
PubMed 36511494Mendes E, Adiyeke O, Sarban O, Civan M, Ozcan FG. Timing of suprainguinal fascia iliaca block in hip hemiarthroplasty: impact on QoR-15 scores- a prospective randomized study. BMC Anesthesiol. 2025 Apr 12;25(1):179. doi: 10.1186/s12871-025-03060-8.
PubMed 40221676
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Application of Fascia Iliaca Compartment Block (FICB) Before or After Spinal Anesthesia on QoR-15 Score in Partial Hip Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT05965544
- Acronym / sponsor ID
- QoR-15 / e.mendes - 2
- Conditions
- Post Operative Pain, Anesthesia, Local, Fracture of Hip, QoR-15
- Keywords
- Fascia Iliaca Compartment Block, FICB, Partial Hip Arthroplasty Surgery, Quality of Recovery-15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 28 Jul 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.
It reduces pain scores in patients with block and improves the quality of recovery in the postoperative period. In patients who will undergo spinal anesthesia, it will be questioned whether the application of the block before or after surgery makes a difference in the quality of recovery.
Detailed description
American Society of Anesthesiologists (ASA) physical status I-III patients who are planned for partial hip arthroplasty will be studied in patients over 65 years of age. The patients will be equally randomized into two groups using a computer-generated random number table. In the preoperative period, according to whether FIBP was before or after spinal anesthesia, it will be named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal). The patient will be placed in the lateral decubitus position with the fractured side up. After the spinal anesthesia method was provided with aseptic conditions, 10 mg 0.5% isobaric bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle through the L3-L4 or L4-L5 intervertebral space. After the patients are in the supine position and aseptic conditions are provided, the fascia on the Iliacus muscle will be determined with the help of an 8-12 MHz linear probe, and the block will be applied with the in-plane technique. During the block, patients will routinely administer 0.2% bupivacaine concentration of 0.5 mL/kg. Demographic data, operation time, perioperative analgesic and sedation need, postoperative pain scores, additional analgesic need, hospitalization and 24th-hour recovery scores will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients were equally randomized into two groups using a computer-generated random number table. In the preoperative period, according to whether FIBP was before or after spinal anesthesia, it was named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal).
| Arm | Type | Receives |
|---|---|---|
| Group PreS | Active comparator | Drug: Bupivacain (preoperative), Drug: Bupivacaine-fentanylThe block will be applied in the preoperative period |
| Group PostS | Active comparator | Drug: Bupivacaine-fentanyl, Drug: Bupivacain (Postoperative)The block will be applied in the postoperative period |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Partial Hip Arthroplasty
- American Society of Anesthesiologists (ASA) physical status I-III,
- Patients aged ≥ 65 years
Key exclusion criteria (9 listed)
- Contraindication for central or peripheral blocks,
- Cognitive Dysfunction,
- History of chronic opioid use,
- Previous hip surgery,
- Serious organ dysfunction,
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 |
|---|---|---|
| Bupivacain (preoperative)Also: Preoperative Fascia Iliaca Compartment BlockAfter the patients are in the supine position and aseptic conditions are provided in the preoperative period, the fascia on the iliacus muscle will be determined with the help of an 8-12 MHz linear probe and a block will be applied with the in-plane technique. During the block, 0.2% bupivacaine concentration 0.5 mL/kg is routinely used in patients. | Drug | Group PreS |
| Bupivacaine-fentanylAlso: Spinal AnesthesiaThe patient will be placed in the lateral decubitus position with the fractured side up. After the spinal anesthesia method was provided with aseptic conditions, 10 mg 0.5% bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle through the L3-L4 or L4-L5 intervertebral space | Drug | Group PostS, Group PreS |
| Bupivacain (Postoperative)Also: Postoperative Fascia Iliaca Compartment BlockAfter the patients are in the supine position and aseptic conditions are provided in the postoperative period, the fascia on the iliacus muscle will be determined with the help of an 8-12 MHz linear probe and a block will be applied with the in-plane technique. During the block, 0.2% bupivacaine concentration 0.5 mL/kg is routinely used in patients. | Drug | Group PostS |
Primary outcome
Change from baseline QoR-15 at 24 hours postoperatively
Time frame: Postoperative 24th-hours
The patient-reported Turkish QoR-15 score includes 15 questions that evaluate the patient's postoperative recovery. The QoR-15 score is grouped under two groups, A and B. A high QoR-15 score, a score between 0 (poor) and 10 (excellent) for each item, and a total score of 150 indicate better quality of recovery.
3 secondary outcomes
Change from baseline Nursing Delirium Screening Scale (N-DSS) at 24 hours postoperatively
Time frame: Postoperative 24th-hours
Postoperative nausea and vomiting
Time frame: Postoperative 24th hour
Analgesic consumption
Time frame: Postoperative 24th hour
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 16 May 2024.
- Background: PubMed 36511494Selvi O, Azizoglu M, Temel G, Tulgar S, Chitneni A, Cinar EN, Ozer Z, Gurkan Y. Translation and Validation of the Turkish Version of the Quality of Postoperative Recovery Score QoR-15: A Multi-Centred Cohort Study. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):443-448. doi: 10.5152/TJAR.2022.21417.
- Derived from this study: PubMed 40221676Mendes E, Adiyeke O, Sarban O, Civan M, Ozcan FG. Timing of suprainguinal fascia iliaca block in hip hemiarthroplasty: impact on QoR-15 scores- a prospective randomized study. BMC Anesthesiol. 2025 Apr 12;25(1):179. doi: 10.1186/s12871-025-03060-8.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared
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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.
Ergun Mendes principal investigator
Başakşehir Çam & Sakura City 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 Bupivacain (preoperative), Bupivacaine-fentanyl and Bupivacain (Postoperative) in people with Post Operative Pain and Anesthesia, Local, run by Başakşehir Çam & Sakura City 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 9 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 16 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?
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?
Change from baseline QoR-15 at 24 hours postoperatively (time frame: Postoperative 24th-hours). 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 NCT05965544, 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 16 May 2024.