Femoral Neck DiseaseNCT06520306
A Study of Ropivacaine Combined With Different Concentrations of Methylene Blue Fascia Iliaca Block in Postoperative Analgesia, Cognition, and Hip Function Recovery in Patients Undergoing Hip Arthroplasty
A study testing Ropivacaine combined with methylene blue for iliac fascia block in people with Femoral Neck Disease, run by Wang wanxia at 1 site in China.
Trial summary
Total hip arthroplasty (THA) is a commonly used treatment for hip lesions, but it is often accompanied by persistent pain after surgery, which obviously affects the quality of life of patients, so perfect postoperative analgesia is particularly important for the rapid recovery of patients. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Femoral Neck Disease
- What is being tested?
- Ropivacaine combined with methylene blue for iliac fascia block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 31 Aug 2024
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hip replacement surgery is indicated
- ASA Class II - Class III
- No history of analgesic or local anesthetic allergy
- No history of alcohol abuse or narcotic drug abuse
- Patients and their families have given informed consent and signed the informed consent form
Who cannot join
- Patient or family refusal to participate in the study
- Severe coagulation abnormalities
- Local anesthetic allergy
- Severe psychiatric illness or other communication disorder
- There is an infection at the puncture site
Trial locations and contacts
1 site in 1 country.
About this study
Total hip arthroplasty (THA) is a commonly used treatment for hip lesions, but it is often accompanied by persistent pain after surgery, which obviously affects the quality of life of patients, so perfect postoperative analgesia is particularly important for the rapid recovery of patients. Peripheral nerve blocks are often used as postoperative analgesia for THA, and fascia iliaca compartment block (FICB) is the preferred nerve block for THA due to its good postoperative analgesic effect and fewer postoperative adverse reactions. However, the effect of nerve block with ropivacaine alone is short, and the postoperative analgesia time is limited, which seriously affects the patient\'s surgical recovery. Therefore, prolonging the postoperative analgesic time is an urgent problem to be solved by FICB, and some scholars recommend the combined use of local anesthetic adjuvants to prolong the block time, which is an effective and safe method. In this study, a long-acting analgesic drug, methylene blue, was selected as an adjuvant for ropivacaine for FICB, but there was no unified clinical standard for the postoperative analgesic concentration of methylene blue.
- Conditions
- Femoral Neck Disease
- Being tested
- Ropivacaine combined with methylene blue for iliac fascia block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine combined with methylene blue for iliac fascia blockDrug
Ultrasound-guided fascia iliaca block using different concentrations of methylene blue combined with ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Dilute 0.25% ropivacaine + 20 mg methylene blue to 30 ml | Experimental | Not described Receives: Drug: Ropivacaine combined with methylene blue for iliac fascia block |
| 0.25% ropivacaine + 40 mg methylene blue diluted to 30 ml | Experimental | Not described Receives: Drug: Ropivacaine combined with methylene blue for iliac fascia block |
| 0.25% ropivacaine 30 ml | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale（VAS）
Use a swimming ruler about 10 cm long, marked with 10 ticks on one side, and "0" and "10" at each end. A score of 0 indicates no pain, a score of 10 indicates the most severe pain that is unbearable, and the higher the score, the greater the degree of pain
Measured: The first, third, and seventh days after the surgery
Mini-Mental State Examination (MMSE)
An examination tool to assess cognitive status
Measured: Seventh day after surgery
Harris Hip Scoring System
Harris (1969) proposed a scoring system to evaluate the functional status and postoperative efficacy of patients with artificial hip arthroplasty
Measured: On the seventh day after surgery
Secondary outcomes (3)
Number of postoperative salvage analgesia
Measured: From the end of the surgery to the seventh day after the surgery
Walking distance for the first time getting out of bed
Measured: From the end of the surgery to the seventh day after the surgery
Number of exercises to get out of bed within 7 days of surgery
Measured: From the end of the surgery to the seventh day after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start15 Mar 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang wanxia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang wanxia, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520306
- Sponsor's protocol ID
- ZY 0717
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 25 Jul 2024
- 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 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Ropivacaine Combined With Different Concentrations of Methylene Blue Fascia Iliaca Block in Postoperative Analgesia, Cognition, and Hip Function Recovery in Patients Undergoing Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06520306
- Acronym / sponsor ID
- ZY 0717
- Conditions
- Femoral Neck Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Wang wanxiaUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 25 Jul 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.
Total hip arthroplasty (THA) is a commonly used treatment for hip lesions, but it is often accompanied by persistent pain after surgery, which obviously affects the quality of life of patients, so perfect postoperative analgesia is particularly important for the rapid recovery of patients. Peripheral nerve blocks are often used as postoperative analgesia for THA, and fascia iliaca compartment block (FICB) is the preferred nerve block for THA due to its good postoperative analgesic effect and fewer postoperative adverse reactions. However, the effect of nerve block with ropivacaine alone is short, and the postoperative analgesia time is limited, which seriously affects the patient\'s surgical recovery. Therefore, prolonging the postoperative analgesic time is an urgent problem to be solved by FICB, and some scholars recommend the combined use of local anesthetic adjuvants to prolong the block time, which is an effective and safe method. In this study, a long-acting analgesic drug, methylene blue, was selected as an adjuvant for ropivacaine for FICB, but there was no unified clinical standard for the postoperative analgesic concentration of methylene blue.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dilute 0.25% ropivacaine + 20 mg methylene blue to 30 ml | Experimental | Drug: Ropivacaine combined with methylene blue for iliac fascia block |
| 0.25% ropivacaine + 40 mg methylene blue diluted to 30 ml | Experimental | Drug: Ropivacaine combined with methylene blue for iliac fascia block |
| 0.25% ropivacaine 30 ml | No intervention | – |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hip replacement surgery is indicated
- ASA Class II - Class III
- No history of analgesic or local anesthetic allergy
- No history of alcohol abuse or narcotic drug abuse
- Patients and their families have given informed consent and signed the informed consent form
Key exclusion criteria (5 listed)
- Patient or family refusal to participate in the study
- Severe coagulation abnormalities
- Local anesthetic allergy
- Severe psychiatric illness or other communication disorder
- There is an infection at the puncture site
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 |
|---|---|---|
| Ropivacaine combined with methylene blue for iliac fascia blockUltrasound-guided fascia iliaca block using different concentrations of methylene blue combined with ropivacaine | Drug | 0.25% ropivacaine + 40 mg methylene blue diluted to 30 ml, Dilute 0.25% ropivacaine + 20 mg methylene blue to 30 ml |
Primary outcome
visual analogue scale（VAS）
Time frame: The first, third, and seventh days after the surgery
Use a swimming ruler about 10 cm long, marked with 10 ticks on one side, and "0" and "10" at each end. A score of 0 indicates no pain, a score of 10 indicates the most severe pain that is unbearable, and the higher the score, the greater the degree of pain
Mini-Mental State Examination (MMSE)
Time frame: Seventh day after surgery
An examination tool to assess cognitive status
Harris Hip Scoring System
Time frame: On the seventh day after surgery
Harris (1969) proposed a scoring system to evaluate the functional status and postoperative efficacy of patients with artificial hip arthroplasty
3 secondary outcomes
Number of postoperative salvage analgesia
Time frame: From the end of the surgery to the seventh day after the surgery
Walking distance for the first time getting out of bed
Time frame: From the end of the surgery to the seventh day after the surgery
Number of exercises to get out of bed within 7 days of surgery
Time frame: From the end of the surgery to the seventh day after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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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 Ropivacaine combined with methylene blue for iliac fascia block in people with Femoral Neck Disease, run by Wang wanxia at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 25 Jul 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 China. 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?
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?
visual analogue scale（VAS） (time frame: The first, third, and seventh days after the surgery). The study lists 3 primary outcomes in all. 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 25 Jul 2024.