Hip OsteoarthritisFIB-PAINNCT06534697
Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty
A study testing Naropin, 0.2% Injectable Solution in Sodium chloride, Naropin, 0.2% Injectable Solution in dextrose 5% and Dextrose 10 % in Water in people with Hip Osteoarthritis, run by Foisor Orthopedics Clinical Hospital.
Trial summary
This clinical trial aims to assess the analgesic efficacy of ultrasound-guided FIB using different analgesic combinations administered into the iliac fascia compartment. The main question it aims to answer is: ·What is the total morphine (mg) consumption at 24 hours postoperatively for each of the three groups? The… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Naropin, 0.2% Injectable Solution in Sodium chloride, Naropin, 0.2% Injectable Solution in dextrose 5% and Dextrose 10 % in Water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2024to 28 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication of total primary hip arthroplasty
- ASA I-III
- BMI<40 kg/m2
Who cannot join
- Inability or refusal to sign informed consent
- Known allergies to any of the drugs used in the study
- Hepatic or renal insufficiency
- Gastritis or gastroduodenal ulcer
- Opioid dependency
- Coagulopathy
Show all 9Show fewer
- Pregnancy
- Scars in the surgery and fascia iliaca block areas
- Clinical evidence of peripheral neuropathies.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analgesic Efficacy of Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty: a Randomised Controlled Study
This clinical trial aims to assess the analgesic efficacy of ultrasound-guided FIB using different analgesic combinations administered into the iliac fascia compartment. The main question it aims to answer is:
·What is the total morphine (mg) consumption at 24 hours postoperatively for each of the three groups?
The secondary questions are:
- What is the length of stay in hospital for each group?
- What is the risk of falling associated with the use of fascia iliaca block? Researchers will compare two analgesic combinations of local anesthestic naropin 0,25% versus dextrose 10% administered by fascia iliaca block for postoperative pain after total hip arthroplasty.
Read the detailed description
The investigators plan to conduct a single-center, prospective, blinded, randomized controlled study of 150 eligible patients undergoing elective THA via a miniinvasive anterior approach starting June 2024. All patients will receive spinal anesthesia and preoperatively FIB for analgesia. The investigators define randomly three patient groups: Group 1, receiving 40 ml naropin 0,25% in saline, Group 2, receiving 40 ml naropin 0,25% in dextrose 5%, and Group 3, receiving 40 ml dextrose 10%. After the regression of spinal anesthesia, all the patients receive the same multimodal pain therapy according to the visual analog scale (VAS), including Paracetamol IV, NSAID, and morphine, according to the pain protocol in our hospital. The primary endpoint of the study is total morphine (mg) consumption at 24 hours postoperatively, and the secondary goals were length of stay and the risk of fall.
- Conditions
- Hip Osteoarthritis
- Being tested
- Naropin, 0.2% Injectable Solution in Sodium chloride, Naropin, 0.2% Injectable Solution in dextrose 5%, Dextrose 10 % in Water
- Keywords
- Fascia iliaca block, Postoperative pain
- Medical subject headings
- Osteoarthritis, Hip, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naropin, 0.2% Injectable Solution in Sodium chlorideDrug
Also called Ropivacaine 0.25%-Sodium chloride
Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in sodium chloride
Naropin, 0.2% Injectable Solution in dextrose 5%Drug
Also called Ropivacaine 0.25%-Dextrose 5%
Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in dextrose 5%
Dextrose 10 % in WaterDrug
Also called Dextrose 10%
Preoperative fascia iliaca block with 40 ml volume of dextrose 10%
| Study group | Role | What they receive |
|---|---|---|
| Naropin 0.25% in sodium chloride | Active comparator | Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in sodium chloride. Receives: Drug: Naropin, 0.2% Injectable Solution in Sodium chloride |
| Naropin 0.25% in dextrose 5% | Active comparator | Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in dextrose 5%. Receives: Drug: Naropin, 0.2% Injectable Solution in dextrose 5% |
| Placebo | Placebo comparator | Preoperative supra inguinal fascia iliaca block with 40 ml dextrose 10%. Receives: Drug: Dextrose 10 % in Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total morphine consumption
The total morphine consumption is measured in mg
Measured: 24 hours postoperatively
Secondary outcomes (2)
The risk of fall
The percent of the number of falls reported to the number of the patients for each arm
Measured: Up to 1 week
Length of stay in hospital
The duration between admision and discharge of the hospital
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start22 Jul 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All enrolled patients will receive spinal anesthesia and preoperatively FIB for analgesia. The investigators randomly define three patient groups using the envelope method: Group 1, receiving 40 ml naropin 0,25% in saline; Group 2, receiving 40 ml naropin 0,25% in dextrose 5%; and Group 3, receiving 40 ml dextrose 10%. After the regression of spinal anesthesia, all the patients receive the same multimodal pain therapy according to the visual analog scale (VAS), including Paracetamol IV, NSAID, and morphine, according to the pain protocol in our hospital. The administration of morphine is according to our hospital protocol. The primary endpoint of the study is total morphine (mg) consumption at 24 hours postoperatively, and the second goal was length of stay and the risk of falls.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foisor Orthopedics Clinical Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anastase Denisa, Foisor Orthopedics Clinical Hospital
- Investigators
- Denisa Anastase, MD, PhD, Principal investigator, Foisor OCHSimona Anastase, MD, PhD, Study director, Foisor OCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534697
- Sponsor's protocol ID
- 07062024
- Acronym
- FIB-PAIN
- Status last verified
- Aug 2024
- First submitted
- 25 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
PubMed 28059869Shariat AN, Hadzic A, Xu D, Shastri U, Kwofie K, Gandhi K, McCally CM, Gratenstein K, Vandepitte C, Gadsden J, Unis D. Fascia lliaca block for analgesia after hip arthroplasty: a randomized double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2013 May-Jun;38(3):201-5. doi: 10.1097/AAP.0b013e31828a3c7c.
PubMed 23558369Wee TC, Neo EJR, Tan YL. Dextrose prolotherapy in knee osteoarthritis: A systematic review and meta-analysis. J Clin Orthop Trauma. 2021 May 20;19:108-117. doi: 10.1016/j.jcot.2021.05.015. eCollection 2021 Aug.
PubMed 34046305Cui X, Cheng Z, Zhang T, Xu H, Luan H, Feng J, Zhang X, Zhu P. Effect of pericapsular nerve group block and suprainguinal fascia iliaca block on postoperative analgesia and stress response in elderly patients undergoing hip arthroplasty: a prospective randomized controlled double-blind trial. BMC Anesthesiol. 2024 Jul 2;24(1):220. doi: 10.1186/s12871-024-02604-8.
PubMed 38956469
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06534697
- Acronym / sponsor ID
- FIB-PAIN / 07062024
- Conditions
- Hip Osteoarthritis
- Keywords
- Fascia iliaca block, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Foisor Orthopedics Clinical HospitalUniversity, hospital or other
- Study start
- 22 Jul 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 2 Aug 2024 (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.
This clinical trial aims to assess the analgesic efficacy of ultrasound-guided FIB using different analgesic combinations administered into the iliac fascia compartment. The main question it aims to answer is:
·What is the total morphine (mg) consumption at 24 hours postoperatively for each of the three groups?
The secondary questions are:
- What is the length of stay in hospital for each group?
- What is the risk of falling associated with the use of fascia iliaca block? Researchers will compare two analgesic combinations of local anesthestic naropin 0,25% versus dextrose 10% administered by fascia iliaca block for postoperative pain after total hip arthroplasty.
Detailed description
The investigators plan to conduct a single-center, prospective, blinded, randomized controlled study of 150 eligible patients undergoing elective THA via a miniinvasive anterior approach starting June 2024. All patients will receive spinal anesthesia and preoperatively FIB for analgesia. The investigators define randomly three patient groups: Group 1, receiving 40 ml naropin 0,25% in saline, Group 2, receiving 40 ml naropin 0,25% in dextrose 5%, and Group 3, receiving 40 ml dextrose 10%. After the regression of spinal anesthesia, all the patients receive the same multimodal pain therapy according to the visual analog scale (VAS), including Paracetamol IV, NSAID, and morphine, according to the pain protocol in our hospital. The primary endpoint of the study is total morphine (mg) consumption at 24 hours postoperatively, and the secondary goals were length of stay and the risk of fall.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- All enrolled patients will receive spinal anesthesia and preoperatively FIB for analgesia. The investigators randomly define three patient groups using the envelope method: Group 1, receiving 40 ml naropin 0,25% in saline; Group 2, receiving 40 ml naropin 0,25% in dextrose 5%; and Group 3, receiving 40 ml dextrose 10%. After the regression of spinal anesthesia, all the patients receive the same multimodal pain therapy according to the visual analog scale (VAS), including Paracetamol IV, NSAID, and morphine, according to the pain protocol in our hospital. The administration of morphine is according to our hospital protocol. The primary endpoint of the study is total morphine (mg) consumption at 24 hours postoperatively, and the second goal was length of stay and the risk of falls.
| Arm | Type | Receives |
|---|---|---|
| Naropin 0.25% in sodium chloride | Active comparator | Drug: Naropin, 0.2% Injectable Solution in Sodium chloridePreoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in sodium chloride. |
| Naropin 0.25% in dextrose 5% | Active comparator | Drug: Naropin, 0.2% Injectable Solution in dextrose 5%Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in dextrose 5%. |
| Placebo | Placebo comparator | Drug: Dextrose 10 % in WaterPreoperative supra inguinal fascia iliaca block with 40 ml dextrose 10%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication of total primary hip arthroplasty
- ASA I-III
- BMI<40 kg/m2
Key exclusion criteria (9 listed)
- Inability or refusal to sign informed consent
- Known allergies to any of the drugs used in the study
- Hepatic or renal insufficiency
- Gastritis or gastroduodenal ulcer
- Opioid dependency
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 |
|---|---|---|
| Naropin, 0.2% Injectable Solution in Sodium chlorideAlso: Ropivacaine 0.25%-Sodium chloridePreoperative fascia iliaca block with 40 ml volume of naropin 0,25% in sodium chloride | Drug | Naropin 0.25% in sodium chloride |
| Naropin, 0.2% Injectable Solution in dextrose 5%Also: Ropivacaine 0.25%-Dextrose 5%Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in dextrose 5% | Drug | Naropin 0.25% in dextrose 5% |
| Dextrose 10 % in WaterAlso: Dextrose 10%Preoperative fascia iliaca block with 40 ml volume of dextrose 10% | Drug | Placebo |
Primary outcome
The total morphine consumption
Time frame: 24 hours postoperatively
The total morphine consumption is measured in mg
2 secondary outcomes
The risk of fall
Time frame: Up to 1 week
Length of stay in hospital
Time frame: Up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 28059869Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
- Background: PubMed 23558369Shariat AN, Hadzic A, Xu D, Shastri U, Kwofie K, Gandhi K, McCally CM, Gratenstein K, Vandepitte C, Gadsden J, Unis D. Fascia lliaca block for analgesia after hip arthroplasty: a randomized double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2013 May-Jun;38(3):201-5. doi: 10.1097/AAP.0b013e31828a3c7c.
- Background: PubMed 34046305Wee TC, Neo EJR, Tan YL. Dextrose prolotherapy in knee osteoarthritis: A systematic review and meta-analysis. J Clin Orthop Trauma. 2021 May 20;19:108-117. doi: 10.1016/j.jcot.2021.05.015. eCollection 2021 Aug.
- Background: PubMed 38956469Cui X, Cheng Z, Zhang T, Xu H, Luan H, Feng J, Zhang X, Zhu P. Effect of pericapsular nerve group block and suprainguinal fascia iliaca block on postoperative analgesia and stress response in elderly patients undergoing hip arthroplasty: a prospective randomized controlled double-blind trial. BMC Anesthesiol. 2024 Jul 2;24(1):220. doi: 10.1186/s12871-024-02604-8.
- 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.
Denisa Anastase, MD, PhD principal investigator
Foisor OCH
Simona Anastase, MD, PhD study director
Foisor OCH
Questions about this trial
What is this clinical trial studying?
A study testing Naropin, 0.2% Injectable Solution in Sodium chloride, Naropin, 0.2% Injectable Solution in dextrose 5% and Dextrose 10 % in Water in people with Hip Osteoarthritis, run by Foisor Orthopedics Clinical Hospital.
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: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Denisa Anastase, MD, PhD (0040721255339, danastase1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total morphine consumption (time frame: 24 hours postoperatively). 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 NCT06534697, which also lists 4 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 2 Aug 2024.