Postoperative Opioid Requirements in Patients With Traumatic Fracture HipNCT05504525
Fascia Iliaca Versus Quadratus Lumborum Block for Pain Management in Total Hip Replacement.
A study testing Fascia Iliaca block and Quadratus lumborum block in people with Postoperative Opioid Requirements in Patients With Traumatic Fracture Hip, run by Ain Shams University at 1 site in Egypt.
Trial summary
Postoperative analgesia is essential for early ambulation of patients with hip arthroplasties as well as decreasing hospital stay time. Fascial plane blocks are emerging as a gold standard for postoperative analgesia instead of opioids and NSAIDs, with all there side effects. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Postoperative Opioid Requirements in Patients With Traumatic Fracture Hip
- What is being tested?
- Fascia Iliaca block and Quadratus lumborum block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2022to 30 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients aging between 40-60 years ASA II, III with no known hypersensitivity for local anesthetics
Who cannot join
- Patient refusal
- Known allergy to local anesthetics
- Previous femoral artery surgery
- Local infection at the site of injection
- Those on anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fascia Iliaca Versus Quadratus Lumborum Block for Postoperative Pain Management in Total Hip Replacement: A Comparative Prospective Randomized Study
Postoperative analgesia is essential for early ambulation of patients with hip arthroplasties as well as decreasing hospital stay time. Fascial plane blocks are emerging as a gold standard for postoperative analgesia instead of opioids and NSAIDs, with all there side effects.
The investigators aim to compare postoperative pain levels and opioid analgesic needs of fascia iliaca block versus quadratus lumborum block in patients undergoing primary total hip arthroplasty under general anesthesia.
- Being tested
- Fascia Iliaca block, Quadratus lumborum block
- Keywords
- opioid requirements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia Iliaca blockProcedure or surgery
Ultrasound guided fascia iliaca block done by palpation of anterior superior iliac spine to identify the inguinal crease, then place the ultrasound probe on it to identify the sartorius muscle. Sonographic anatomy will be identified, from superficial to deep, consisting of subcutaneous fat, the internal oblique muscle, the transverse abdominis muscle, the fascia iliaca covering the iliacus muscle and the iliacus muscle itself. The block needle will be advanced in out-of plane to puncture the fascia iliaca. With the needle tip just below the fascia iliaca, 2 ml of a local anesthetic will be injected to confirm the tip location. Once the proper position is confirmed, 40 ml of bupivacaine 0.25% will be injected superficial to the iliacus muscle and deep to the fascia iliaca.
Quadratus lumborum blockProcedure or surgery
The patients will receive anterior ultrasound guided quadratus lumborum block QLB in the lateral position. The transducer will be first placed in a parasagittal orientation 3-4 cm lateral to the midline and over the sacrum to identify the L5 transverse process. The probe will then rotated into a transverse orientation with slight medial and caudal angulation to obtain a transverse oblique view at L5 transverse process .The ultrasound probe will be tilted , so the lateral end of the probe will be more cranial than the medial side of the probe to avoid the acoustic shadow of the iliac crest. Identify the quadratus lumborum and psoas major and inject the local anesthetic above the QL
| Study group | Role | What they receive |
|---|---|---|
| Fascia iliaca block for postoperative pain management in hip arthroplasty | Active comparator | Not described Receives: Procedure: Fascia Iliaca block |
| Quadratus lumborum block for postoperative pain management in hip arthroplasty | Active comparator | Not described Receives: Procedure: Quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative analgesia
The investigators will measure the time to first analgesic request after giving the block
Measured: 24 hours
Secondary outcomes (2)
Total rescue analgesic requirements
Measuring the total rescue analgesic requirement in the postoperative period
Measured: 24 hours
Functional recovery
Will be assessed by duration of hospital stay
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start30 May 2022
- Primary completion3 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Opioid Requirements in Patients With Traumatic Fracture HipStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Refaat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504525
- Sponsor's protocol ID
- R118/2021
- Status last verified
- Jan 2023
- First submitted
- 4 Jun 2022
- Last updated
- 20 Jan 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 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascia Iliaca Versus Quadratus Lumborum Block for Postoperative Pain Management in Total Hip Replacement: A Comparative Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05504525
- Acronym / sponsor ID
- R118/2021
- Keywords
- opioid requirements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 3 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 17 Aug 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.
Postoperative analgesia is essential for early ambulation of patients with hip arthroplasties as well as decreasing hospital stay time. Fascial plane blocks are emerging as a gold standard for postoperative analgesia instead of opioids and NSAIDs, with all there side effects.
The investigators aim to compare postoperative pain levels and opioid analgesic needs of fascia iliaca block versus quadratus lumborum block in patients undergoing primary total hip arthroplasty under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia iliaca block for postoperative pain management in hip arthroplasty | Active comparator | Procedure: Fascia Iliaca block |
| Quadratus lumborum block for postoperative pain management in hip arthroplasty | Active comparator | Procedure: Quadratus lumborum block |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients aging between 40-60 years ASA II, III with no known hypersensitivity for local anesthetics
Key exclusion criteria (5 listed)
- Patient refusal
- Known allergy to local anesthetics
- Previous femoral artery surgery
- Local infection at the site of injection
- Those on anticoagulation therapy
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 blockUltrasound guided fascia iliaca block done by palpation of anterior superior iliac spine to identify the inguinal crease, then place the ultrasound probe on it to identify the sartorius muscle. Sonographic anatomy will be identified, from superficial to deep, consisting of subcutaneous fat, the internal oblique muscle, the transverse abdominis muscle, the fascia iliaca covering the iliacus muscle and the iliacus muscle itself. The block needle will be advanced in out-of plane to puncture the fascia iliaca. With the needle tip just below the fascia iliaca, 2 ml of a local anesthetic will be injected to confirm the tip location. Once the proper position is confirmed, 40 ml of bupivacaine 0.25% will be injected superficial to the iliacus muscle and deep to the fascia iliaca. | Procedure or surgery | Fascia iliaca block for postoperative pain management in hip arthroplasty |
| Quadratus lumborum blockThe patients will receive anterior ultrasound guided quadratus lumborum block QLB in the lateral position. The transducer will be first placed in a parasagittal orientation 3-4 cm lateral to the midline and over the sacrum to identify the L5 transverse process. The probe will then rotated into a transverse orientation with slight medial and caudal angulation to obtain a transverse oblique view at L5 transverse process .The ultrasound probe will be tilted , so the lateral end of the probe will be more cranial than the medial side of the probe to avoid the acoustic shadow of the iliac crest. Identify the quadratus lumborum and psoas major and inject the local anesthetic above the QL | Procedure or surgery | Quadratus lumborum block for postoperative pain management in hip arthroplasty |
Primary outcome
Duration of postoperative analgesia
Time frame: 24 hours
The investigators will measure the time to first analgesic request after giving the block
2 secondary outcomes
Total rescue analgesic requirements
Time frame: 24 hours
Functional recovery
Time frame: 72 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 20 Jan 2023.
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 Fascia Iliaca block and Quadratus lumborum block in people with Postoperative Opioid Requirements in Patients With Traumatic Fracture Hip, run by Ain Shams University at 1 site in Egypt.
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 5 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 20 Jan 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 Egypt. 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?
Duration of postoperative analgesia (time frame: 24 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 20 Jan 2023.