Postoperative PainNCT05642975
Comparing Suprainguinal Fascia Iliaca Block With Erector Spinae Plane Block in Hip and Proximal Femur Surgery
A study testing Regional Block Comparison in people with Postoperative Pain and Femur Fracture, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Most hip fractures occur in the elderly population. Opioid-related respiratory depression is more common in the elderly population but can cause severe brain damage or death. Reducing the amount of opioids administered before, during and after surgery by adding a regional block may increase the postoperative quality… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Femur Fracture, Regional Anesthesia
- What is being tested?
- Regional Block Comparison
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 May 2023
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years old, undergoing hip fracture surgery
Who cannot join
- Patients with solid organ dysfunction, chronic opioid or corticosteroid use, bleeding diathesis, patients receiving inpatient medication, patients with psychiatric disorders and patients who cannot be contacted after surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Ultrasound-Guided Suprainguinal Fascia Iliaca Block With Lumbar Erector Spinae Plane Block in Hip and Proximal Femur Fracture Surgery
Most hip fractures occur in the elderly population. Opioid-related respiratory depression is more common in the elderly population but can cause severe brain damage or death. Reducing the amount of opioids administered before, during and after surgery by adding a regional block may increase the postoperative quality of recovery, reduce chronic pain syndromes, and may potentially facilitate the participation of patients in rehabilitation.
Despite their potential advantages, peripheral nerve blocks are still not widely used in people with hip fractures.
The primary objective of this study is to compare patients' postoperative pain scores and opioid consumption.
- Conditions
- Postoperative Pain, Femur Fracture, Regional Anesthesia
- Being tested
- Regional Block Comparison
- Keywords
- Postoperative Pain, Lumbar Erector Spinae Plane Block, Fascia Iliaca Block
- Medical subject headings
- Pain, Postoperative, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional Block ComparisonProcedure or surgery
Comparing postoperative pain and opioid consumption in groups
| Study group | Role | What they receive |
|---|---|---|
| Suprainguinal Fascia Iliaca Block | Active comparator | The probe was placed over the inguinal ligament in close proximity to the anterior superior iliac spine and oriented in the parasagittal plane. It was then moved inferomedially along the line of the inguinal ligament to visualize the 'bow-tie' sign. After confirming the needle's position, a total volume of 30 ml of bupivacaine 0.25% was injected.
Spinal anesthesia was administered to the patients in a lateral position using 2.5 ml of 0.5% heavy bupivacaine at the L3-L4 level. Receives: Procedure: Regional Block Comparison |
| Erector Spinae Plane Block | Active comparator | The L5, L4, and L3 transverse processes and erector spinae muscles posteriorly were identified using ultrasound. The curved 6-2 MHz transducer was initially placed at the mid-vertebral line in the sagittal plane and then shifted laterally to visualize the erector spinae muscle and transverse process of the L3 vertebra. A total volume of 40 ml of bupivacaine 0.25% was injected.
Spinal anesthesia was administered to the patients in a lateral position using 2.5 ml of 0.5% heavy bupivacaine at the L3-L4 level. Receives: Procedure: Regional Block Comparison |
| Spinal Anesthesia Group (control) | Active comparator | Spinal anesthesia was administered to the patients in a lateral position using 2.5 ml of 0.5% heavy bupivacaine at the L3-L4 level. Receives: Procedure: Regional Block Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Comparing opioid consumption via Patient Controlled Analgesia (PCA) device
Measured: 48 hours
Secondary outcomes (4)
Patient Satisfaction
patient satisfaction score: 0: unsatisfied 5: fully satisfied
Measured: 48 hours
Complications Related to Pain Management
complications such as hypothension, nausea, vomiting, itching
Measured: 48 hours
Postoperative Pain Scores
Comparing pain scores with Numeric Rating Scale (NRS)
Measured: 48 hours
The lengths of ICU and hospital stays
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Aug 2022
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642975
- Sponsor's protocol ID
- 11.2022.546
- Status last verified
- Aug 2024
- First submitted
- 30 Nov 2022
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Ultrasound-Guided Suprainguinal Fascia Iliaca Block With Lumbar Erector Spinae Plane Block in Hip and Proximal Femur Fracture Surgery
- ClinicalTrials.gov ID
- NCT05642975
- Acronym / sponsor ID
- 11.2022.546
- Conditions
- Postoperative Pain, Femur Fracture, Regional Anesthesia
- Keywords
- Postoperative Pain, Lumbar Erector Spinae Plane Block, Fascia Iliaca Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 8 Dec 2022 (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.
Most hip fractures occur in the elderly population. Opioid-related respiratory depression is more common in the elderly population but can cause severe brain damage or death. Reducing the amount of opioids administered before, during and after surgery by adding a regional block may increase the postoperative quality of recovery, reduce chronic pain syndromes, and may potentially facilitate the participation of patients in rehabilitation.
Despite their potential advantages, peripheral nerve blocks are still not widely used in people with hip fractures.
The primary objective of this study is to compare patients' postoperative pain scores and opioid consumption.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suprainguinal Fascia Iliaca Block | Active comparator | Procedure: Regional Block ComparisonThe probe was placed over the inguinal ligament in close proximity to the anterior superior iliac spine and oriented in the parasagittal plane. It was then moved inferomedially along the line of the inguinal ligament to visualize the 'bow-tie' sign. After confirming the needle's position, a total volume of 30 ml of bupivacaine 0.25% was injected. Spinal anesthesia was administered to the patients in a lateral position using 2.5 ml of 0.5% heavy bupivacaine at the L3-L4 level. |
| Erector Spinae Plane Block | Active comparator | Procedure: Regional Block ComparisonThe L5, L4, and L3 transverse processes and erector spinae muscles posteriorly were identified using ultrasound. The curved 6-2 MHz transducer was initially placed at the mid-vertebral line in the sagittal plane and then shifted laterally to visualize the erector spinae muscle and transverse process of the L3 vertebra. A total volume of 40 ml of bupivacaine 0.25% was injected. Spinal anesthesia was administered to the patients in a lateral position using 2.5 ml of 0.5% heavy bupivacaine at the L3-L4 level. |
| Spinal Anesthesia Group (control) | Active comparator | Procedure: Regional Block ComparisonSpinal anesthesia was administered to the patients in a lateral position using 2.5 ml of 0.5% heavy bupivacaine at the L3-L4 level. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years old, undergoing hip fracture surgery
Key exclusion criteria (1 listed)
- Patients with solid organ dysfunction, chronic opioid or corticosteroid use, bleeding diathesis, patients receiving inpatient medication, patients with psychiatric disorders and patients who cannot be contacted after surgery.
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 |
|---|---|---|
| Regional Block ComparisonComparing postoperative pain and opioid consumption in groups | Procedure or surgery | Erector Spinae Plane Block, Spinal Anesthesia Group (control), Suprainguinal Fascia Iliaca Block |
Primary outcome
Opioid Consumption
Time frame: 48 hours
Comparing opioid consumption via Patient Controlled Analgesia (PCA) device
4 secondary outcomes
Patient Satisfaction
Time frame: 48 hours
Complications Related to Pain Management
Time frame: 48 hours
Postoperative Pain Scores
Time frame: 48 hours
The lengths of ICU and hospital stays
Time frame: 7 days
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 26 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Regional Block Comparison in people with Postoperative Pain and Femur Fracture, run by Marmara 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 1 inclusion and 1 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 26 Aug 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?
Opioid Consumption (time frame: 48 hours). 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 Aug 2024.