Hip FracturesNCT05941208
Efficacy of Continuous Fascia Iliaca Block in Hip Surgery in Elderly
A study testing continuous fascia iliaca compartment block in people with Hip Fractures, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to investigate the analgesic effect of ultrasound-guided Continuous fascia iliaca block in very elderly patients with hip fracture after hip surgery compared to systemic analgesia . Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- continuous fascia iliaca compartment block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Apr 2023to Oct 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age > 65 years
- American Society of Anesthesiologists (ASA) physical status classification class II,III
Who cannot join
- age < 65 years
- ASA IIII
- refusal of peripheral nerve block
- infection at the site of injection
- coagulopathy INR > 1.8
- platelets count < 50,000
- known allergy to used medications.
Trial locations and contacts
1 site in 1 country.
samuel H Daniel, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospital
Cairo
lydia E zakhary, MD, 01222555128, lydia_zakhary@med.asu.edu.eg
About this study
Official title: Efficacy of Continuous Fascia Iliaca Block in Hip Surgery in Elderly : a Randomized Controlled Clinical Trial
The goal of this clinical trial is to investigate the analgesic effect of ultrasound-guided Continuous fascia iliaca block in very elderly patients with hip fracture after hip surgery compared to systemic analgesia .
The main question[s] it aims to answer are:
Read more
- does continuous fascia iliaca block provide adequate post operative analgesia after hip surgery ?
- does it lower the incidence of post operative complications in old age ? Participants will receive continuous fascia iliaca block through ultrasound , introducing epidural catheter 18 G , continuous infusion of bupivacaine 0.25% by a set rate of 7 ml per hour for 24 hours.
Researchers will compare the study group receiving continuous fascia iliaca block to the control group receiving traditional systemic analgesia in the post operative period . to see if the analgesic effect is more effective
Read the detailed description
Patients meeting the inclusion criteria were randomly assigned into two groups, the control group and the study group, by a computer-generated randomization program. All patients in both group will be informed by the study methods,aim, side effect in clear language, written consent will be taken in clear spoken and written language, All patients of both groups ,once arrived to the OR, monitor will be attached, baseline SBP, DBP,MAP,SPO2,PULSE will be recorded, spinal anesthesia will be performed as follows, after sterilization of the back with bovidon iodine, local anesthesia 3cc of lidocaine 20% will be injected at the level of L3-L4 spine , then injection of 17 mg bupivacaine 0.5% through a 25 spinal needle.
At the end of surgery, Goup 1 will receive continuous fascia iliaca block through ultrasound Patients were in supine position and the puncture site was selected at 1 cm below the junction point at 1/3 of the connection of anterior superior spine and pubic tubercle. An ultrasound apparatus (Sonosite) high-frequency probe was placed in parallel to the inguinal fold to distinguish the femoral fascia and fascia iliaca, the needle was inserted with out-of-plane technique at an angle of 45° and the tip of the needle was pointed to the head.Once needle-tip placement under the fascia iliaca by hydrolocation was confirmed, the probe was rotated 90° into a longitudinal parasagittal orientation to visualize the needle tip in-plane and to track cephalad spread of the injectate under fascia iliaca, identification of the fascia iliaca plane through the linear probe and introducing epidural catheter 18 G , continuous infusion of bupivacaine 0.25% by a set rate of 7 ml per hour for 24 hours The control group will receive traditional analgesia including 50 mg pethidine with a maximum 6 hour interval and 1gm paracetamol as per need .
- Conditions
- Hip Fractures
- Being tested
- continuous fascia iliaca 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.
continuous fascia iliaca compartment blockProcedure or surgery
ultrasound Patients were in supine position and the puncture site was selected at 1 cm below the junction point at 1/3 of the connection of anterior superior spine and pubic tubercle. An ultrasound apparatus (Sonosite) high-frequency probe was placed in parallel to the inguinal fold to distinguish the femoral fascia and fascia iliaca, the needle was inserted with out-of-plane technique at an angle of 45° and the tip of the needle was pointed to the head. Once needle-tip placement under the fascia iliaca by hydrolocation was confirmed, the probe was rotated 90° into a longitudinal parasagittal orientation to visualize the needle tip in-plane and to track cephalad spread of the injectate under fascia iliaca, identification of the fascia iliaca plane through the linear probe and introducing epidural catheter 18 G , continuous infusion of bupivacaine 0.25% by a set rate of 7 ml per hour for 24 hours,
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| study group | Active comparator | receiving post operative continuous fascia iliaca compartement block for 24 hours Receives: Procedure: continuous fascia iliaca compartment block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the postoperative analgesic effect
measuring the degree of postoperative analgesia provided by continuous fascia iliaca compartement block using the Visual analogue score for pain ( 11 point scale where 0 indicates no pain, 10 indicates the worst pain imaginable )
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 posted12 Jul 2023
- Study start9 Apr 2023
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia edward aziz zakhary, Ain Shams University
- Investigators
- Lydia E Zakhary, MD, Principal investigator, Ainshams U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941208
- Sponsor's protocol ID
- Continuous Fascia iliaca block
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rasappan K, Chua ITH, Tey JBL, Ho SWL. The continuous infusion fascia iliaca compartment block: a safe and effective analgesic modality in geriatric hip fracture patients. Arch Orthop Trauma Surg. 2021 Jan;141(1):29-37. doi: 10.1007/s00402-020-03450-2. Epub 2020 May 2.
PubMed 32361955
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Continuous Fascia Iliaca Block in Hip Surgery in Elderly : a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05941208
- Acronym / sponsor ID
- Continuous Fascia iliaca block
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 9 Apr 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 12 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.
The goal of this clinical trial is to investigate the analgesic effect of ultrasound-guided Continuous fascia iliaca block in very elderly patients with hip fracture after hip surgery compared to systemic analgesia .
The main question[s] it aims to answer are:
- does continuous fascia iliaca block provide adequate post operative analgesia after hip surgery ?
- does it lower the incidence of post operative complications in old age ? Participants will receive continuous fascia iliaca block through ultrasound , introducing epidural catheter 18 G , continuous infusion of bupivacaine 0.25% by a set rate of 7 ml per hour for 24 hours.
Researchers will compare the study group receiving continuous fascia iliaca block to the control group receiving traditional systemic analgesia in the post operative period . to see if the analgesic effect is more effective
Detailed description
Patients meeting the inclusion criteria were randomly assigned into two groups, the control group and the study group, by a computer-generated randomization program. All patients in both group will be informed by the study methods,aim, side effect in clear language, written consent will be taken in clear spoken and written language, All patients of both groups ,once arrived to the OR, monitor will be attached, baseline SBP, DBP,MAP,SPO2,PULSE will be recorded, spinal anesthesia will be performed as follows, after sterilization of the back with bovidon iodine, local anesthesia 3cc of lidocaine 20% will be injected at the level of L3-L4 spine , then injection of 17 mg bupivacaine 0.5% through a 25 spinal needle.
At the end of surgery, Goup 1 will receive continuous fascia iliaca block through ultrasound Patients were in supine position and the puncture site was selected at 1 cm below the junction point at 1/3 of the connection of anterior superior spine and pubic tubercle. An ultrasound apparatus (Sonosite) high-frequency probe was placed in parallel to the inguinal fold to distinguish the femoral fascia and fascia iliaca, the needle was inserted with out-of-plane technique at an angle of 45° and the tip of the needle was pointed to the head.Once needle-tip placement under the fascia iliaca by hydrolocation was confirmed, the probe was rotated 90° into a longitudinal parasagittal orientation to visualize the needle tip in-plane and to track cephalad spread of the injectate under fascia iliaca, identification of the fascia iliaca plane through the linear probe and introducing epidural catheter 18 G , continuous infusion of bupivacaine 0.25% by a set rate of 7 ml per hour for 24 hours The control group will receive traditional analgesia including 50 mg pethidine with a maximum 6 hour interval and 1gm paracetamol as per need .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| study group | Active comparator | Procedure: continuous fascia iliaca compartment blockreceiving post operative continuous fascia iliaca compartement block for 24 hours |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- age > 65 years
- American Society of Anesthesiologists (ASA) physical status classification class II,III
Key exclusion criteria (7 listed)
- age < 65 years
- ASA IIII
- refusal of peripheral nerve block
- infection at the site of injection
- coagulopathy INR > 1.8
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 |
|---|---|---|
| continuous fascia iliaca compartment blockultrasound Patients were in supine position and the puncture site was selected at 1 cm below the junction point at 1/3 of the connection of anterior superior spine and pubic tubercle. An ultrasound apparatus (Sonosite) high-frequency probe was placed in parallel to the inguinal fold to distinguish the femoral fascia and fascia iliaca, the needle was inserted with out-of-plane technique at an angle of 45° and the tip of the needle was pointed to the head. Once needle-tip placement under the fascia iliaca by hydrolocation was confirmed, the probe was rotated 90° into a longitudinal parasagittal orientation to visualize the needle tip in-plane and to track cephalad spread of the injectate under fascia iliaca, identification of the fascia iliaca plane through the linear probe and introducing epidural catheter 18 G , continuous infusion of bupivacaine 0.25% by a set rate of 7 ml per hour for 24 hours, | Procedure or surgery | study group |
Primary outcome
Evaluating the postoperative analgesic effect
Time frame: 24 hours
measuring the degree of postoperative analgesia provided by continuous fascia iliaca compartement block using the Visual analogue score for pain ( 11 point scale where 0 indicates no pain, 10 indicates the worst pain imaginable )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Background: PubMed 32361955Rasappan K, Chua ITH, Tey JBL, Ho SWL. The continuous infusion fascia iliaca compartment block: a safe and effective analgesic modality in geriatric hip fracture patients. Arch Orthop Trauma Surg. 2021 Jan;141(1):29-37. doi: 10.1007/s00402-020-03450-2. Epub 2020 May 2.
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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.
samuel H Daniel, MD contact
Lydia E Zakhary, MD principal investigator
Ainshams U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous fascia iliaca compartment block in people with Hip Fractures, 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lydia E Zakhary, MD (00201222555128, lydia_zakhary@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the postoperative analgesic effect (time frame: 24 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 NCT05941208, which also lists 1 linked publication.
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 18 Jul 2023.