Nerve BlockNCT05228028
Fascia Iliaca Compartment Block Versus Quadratus Lumborum Block in Total Hip Arthroplasty
A study testing fascia iliaca compartement block and quadratus lumborum block in people with Nerve Block and Pain, Postoperative, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Patients undergoing total hip arthroplasty are randomly assigned to two groups (fascia iliaca compartement block [FICB] group or quadratus lumborum block [QLB] group). In the FICB group, ultrasound-guided suprainguinal FICB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is performed on the ipsilateral… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Nerve Block, Pain, Postoperative
- What is being tested?
- fascia iliaca compartement block and quadratus lumborum block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Mar 2022to 22 Dec 2022
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients between the ages of 19 and 70 undergoing total hip arthroplasty under spinal anesthesia
- Be able to provide written consent to participate in clinical trials, understand the procedures of this clinical trial, and be able to properly fill out patient-reported questionnaires
- ASA physical status classification 1-2
Who cannot join
- ASA physical status classification 3-4
- Patients who are contraindicated to nerve blocks (hypersensitivity to local anesthetics, infection at the injection site, etc.)
- Patients with chronic pain and taking pain medications, antidepressants, and anticonvulsants
- Other major medical or psychiatric conditions that will affect response to treatment
- Refusal of intravenous patient-controlled analgesia
- Patients determined to be unsuitable for this clinical trial by the researchers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suprainguinal Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block for Analgesia After Total Hip Arthroplasty: a Randomized Controlled Trial
Patients undergoing total hip arthroplasty are randomly assigned to two groups (fascia iliaca compartement block [FICB] group or quadratus lumborum block [QLB] group). In the FICB group, ultrasound-guided suprainguinal FICB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is performed on the ipsilateral surgical side at the end of surgery. In the QLB group, ultrasound-guided anterior QLB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery. A standardized multimodal analgesic regimen is used for postoperative pain control. The total use of opioids including patient-controlled analgesia and rescue analgesics is compared in both groups for 24 hours after surgery. The amount of opioids used is compared by conversion to oral morphine equivalent dose. Pain score at rest and movement during postoperative 24 hours, time to first request for analgesics, the incidence of side effects, patient satisfaction for pain control at postoperative 24 hours, quality of recovery at postoperative 24 hours, time to discharge readiness, and hospital length of stay are compared.
- Conditions
- Nerve Block, Pain, Postoperative
- Being tested
- fascia iliaca compartement block, quadratus lumborum block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fascia iliaca compartement blockProcedure or surgery
Also called FICB
Ultrasound-guided suprainguinal FICB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery.
quadratus lumborum blockProcedure or surgery
Also called QLB
Ultrasound-guided anterior QLB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| fascia iliaca compartement block [FICB] group | Experimental | Not described Receives: Procedure: fascia iliaca compartement block |
| quadratus lumborum block [QLB] group | Experimental | Not described Receives: Procedure: quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioids use for 24 hours
Total dose of opioids used upto 24 hours after surgery (morphine milligram equivalents)
Measured: Over the first 24 hours after surgery
Secondary outcomes (8)
Postoperative pain at rest (Numeric rating scale)
Postoperative pain at rest (Numeric rating scale; minimum 0, maximum 10, a higher score means more pain)
Measured: At postoperative 4, 8, 12, 16, 20, 24 hours
Postoperative pain with movement (Numeric rating scale)
Postoperative pain with movement (Numeric rating scale; minimum 0, maximum 10, a higher score means more pain)
Measured: At postoperative 4, 8, 12, 16, 20, 24 hours
Time to first request for pain medication
Time to first request for pain medication after surgery
Measured: From the end of surgery to discharge, an average of 4 days
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting (%)
Measured: Over the first 24 hours after surgery
Patient satisfaction score with pain control at 24 hours after surgery
Patient satisfaction score with pain control at 24 hours after surgery (minimum 0, maximum 10, a higher score means higher satisfaction)
Measured: At 24 hours after surgery
Quality of Recovery at 24 hours after surgery
Quality of Recovery at 24 hours after surgery assessed by QoR-15 questionnaire
Measured: At 24 hours after surgery
Time to discharge readiness
Days of hospitalization after surgery until discharge readiness (defined as satisfying the following three criteria; (1) adequate pain control (numeric rating scale score < 4), (2) no intravenous opioid use in the past 12 hours, and (3) able to walk at least 30 m without time limit)
Measured: From the end of surgery to discharge, an average of 4 days
Hospital length of stay
Days of hospitalization after surgery until discharge
Measured: From the end of surgery to discharge, an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start22 Mar 2022
- Primary completion21 Oct 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seokha Yoo, Seoul National University Hospital
- Investigators
- Seokha Yoo, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228028
- Sponsor's protocol ID
- 2112-062-1282
- Status last verified
- Dec 2022
- First submitted
- 18 Jan 2022
- Last updated
- 28 Dec 2022
- Results posted
- 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 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprainguinal Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block for Analgesia After Total Hip Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05228028
- Acronym / sponsor ID
- 2112-062-1282
- Conditions
- Nerve Block, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 8 Feb 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.
Patients undergoing total hip arthroplasty are randomly assigned to two groups (fascia iliaca compartement block [FICB] group or quadratus lumborum block [QLB] group). In the FICB group, ultrasound-guided suprainguinal FICB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is performed on the ipsilateral surgical side at the end of surgery. In the QLB group, ultrasound-guided anterior QLB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery. A standardized multimodal analgesic regimen is used for postoperative pain control. The total use of opioids including patient-controlled analgesia and rescue analgesics is compared in both groups for 24 hours after surgery. The amount of opioids used is compared by conversion to oral morphine equivalent dose. Pain score at rest and movement during postoperative 24 hours, time to first request for analgesics, the incidence of side effects, patient satisfaction for pain control at postoperative 24 hours, quality of recovery at postoperative 24 hours, time to discharge readiness, and hospital length of stay are compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fascia iliaca compartement block [FICB] group | Experimental | Procedure: fascia iliaca compartement block |
| quadratus lumborum block [QLB] group | Experimental | Procedure: quadratus lumborum block |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients between the ages of 19 and 70 undergoing total hip arthroplasty under spinal anesthesia
- Be able to provide written consent to participate in clinical trials, understand the procedures of this clinical trial, and be able to properly fill out patient-reported questionnaires
- ASA physical status classification 1-2
Key exclusion criteria (6 listed)
- ASA physical status classification 3-4
- Patients who are contraindicated to nerve blocks (hypersensitivity to local anesthetics, infection at the injection site, etc.)
- Patients with chronic pain and taking pain medications, antidepressants, and anticonvulsants
- Other major medical or psychiatric conditions that will affect response to treatment
- Refusal of intravenous patient-controlled analgesia
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 |
|---|---|---|
| fascia iliaca compartement blockAlso: FICBUltrasound-guided suprainguinal FICB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery. | Procedure or surgery | fascia iliaca compartement block [FICB] group |
| quadratus lumborum blockAlso: QLBUltrasound-guided anterior QLB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery. | Procedure or surgery | quadratus lumborum block [QLB] group |
Primary outcome
Total opioids use for 24 hours
Time frame: Over the first 24 hours after surgery
Total dose of opioids used upto 24 hours after surgery (morphine milligram equivalents)
8 secondary outcomes
Postoperative pain at rest (Numeric rating scale)
Time frame: At postoperative 4, 8, 12, 16, 20, 24 hours
Postoperative pain with movement (Numeric rating scale)
Time frame: At postoperative 4, 8, 12, 16, 20, 24 hours
Time to first request for pain medication
Time frame: From the end of surgery to discharge, an average of 4 days
Incidence of postoperative nausea and vomiting
Time frame: Over the first 24 hours after surgery
Patient satisfaction score with pain control at 24 hours after surgery
Time frame: At 24 hours after surgery
Quality of Recovery at 24 hours after surgery
Time frame: At 24 hours after surgery
Time to discharge readiness
Time frame: From the end of surgery to discharge, an average of 4 days
Hospital length of stay
Time frame: From the end of surgery to discharge, an average of 4 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 28 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Seokha Yoo, M.D. principal investigator
Seoul National University 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 fascia iliaca compartement block and quadratus lumborum block in people with Nerve Block and Pain, Postoperative, run by Seoul National University Hospital at 1 site in South Korea.
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 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 28 Dec 2022. 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 South Korea. 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?
Total opioids use for 24 hours (time frame: Over the first 24 hours 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 28 Dec 2022.