Knee DiseaseNCT05325827
Effect of Ultrasound-guided H-FICB in Patients Undergoing Arthroscopic Knee Surgery
A study testing ultrasound-guided high fascia iliaca compartment block in people with Knee Disease and Delirium, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Arthroscopic knee surgery is a minimally invasive operation. Postoperative pain usually occurs, especially within 24 hours after surgery, the incidence of pain can be more than 76%. Pain will affect the patient's emotions and life, cause adverse effects, and even lead to postoperative delirium. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Disease, Delirium
- What is being tested?
- ultrasound-guided high fascia iliaca compartment block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2022to 5 Feb 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years male and female
- Scheduled for elective arthroscopic knee surgery
- The patients volunteered to participate in the study and signed the informed consent
Who cannot join
- Preexisting neuropathy
- Coagulopathy
- Local skin infection
- Hepatic, renal, or cardiorespiratory failure
- Local anesthetic allergy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 0513
Xingguo Xu, 18621526251, xxgtdfy@163.com
About this study
Official title: Effect of Ultrasound-guided High Fascia Iliaca Compartment Block in Patients Undergoing Arthroscopic Knee Surgery: A Prospective, Double-Blind, Randomized, Clinical Trial
Arthroscopic knee surgery is a minimally invasive operation. Postoperative pain usually occurs, especially within 24 hours after surgery, the incidence of pain can be more than 76%. Pain will affect the patient's emotions and life, cause adverse effects, and even lead to postoperative delirium. This study aimed to investigate the clinical effect of ultrasound-guided high fascia iliaca compartment block(H-FICB) in patients undergoing knee arthroscopy and to compare it with the normal method which is femoral nerve block combined with a sciatic nerve block to choose the better way. A double-blind, randomized controlled trial was conducted with 44 patients, aged 18-65 years, ASA I-III, who were scheduled to undergo arthroscopic knee surgery in our hospital were selected, the patients were divided into Group A and Group B by random number table method, with 22 patients in each group. Group A was subjected to the H-FICB under ultrasound guidance before general anesthesia, given 0.375% ropivacaine 30 ml. Group B received ultrasound-guided femoral nerve block combined with sciatic nerve block before general anesthesia, given 0.375% ropivacaine 30 ml.
The mini-mental State Examination was used to assess all the patients' primary cognitive status one day before surgery. The initial acting time and the degrees of sensory block and motor block were recorded after the nerve block was completed. Perioperative variables were recorded to be compared. The investigators used the visual analog scale to assess patients' pain degree with postoperative, recorded the occurrence of adverse events such as postoperative nausea and vomiting(PONV), delayed emergence from anesthesia, and respiratory depression. The confusion assessment method was used to assess whether patients experienced delirium.
Read the detailed description
- Study design and setting 44 patients undergoing arthroscopic knee surgery under general anesthesia, gender, aged 18-65 years, American Society of Anesthesiologists (ASA) physical status I-III. Exclusion criteria: MMSE of 1 day before surgery < 27, communication and dysfunction (e.g., vision, hearing), cerebrovascular history, local anesthetic allergy, opioid allergy, puncture site infection, abnormal clotting.
- Subjects Patients were allocated randomly to A group (the high fascia iliaca compartment block group) and B group (the femoral nerve block combined with sciatic nerve block group) according to a computer-generated random number table. All patients and an investigator who was responsible for follow-up during 48 postoperative hours were blinded to the randomization groups. In addition, during preoperative visits, the investigators instructed patients on how to use the patient-controlled intravenous analgesia (PCA) device for pain management, as well as how to use the visual analog scale to evaluate pain at rest and while coughing. All the bispectral index (BIS) value in the present study was maintained between 40 and 60 during surgery. All patients voluntarily signed informed consent.
- General anesthesia Patients were monitored by electrocardiogram, pulse oximetry, and non-invasive blood pressure (one measurement every 3 min) while entering the operation room. A radial artery catheter was also placed for invasive arterial pressure and blood gas monitoring. The induction of general anesthesia was performed intravenously with sufentanil 0.5 µg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Endotracheal intubation was performed with a double-lumen tube. Sevoflurane was used at a minimal alveolar concentration (MAC) of 0.8-1, remifentanil and propofol were used for the maintenance. Fluid management was at the discretion of the attending anaesthesiologist.
- Conditions
- Knee Disease, Delirium
- Being tested
- ultrasound-guided high fascia iliaca compartment block
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided high fascia iliaca compartment blockProcedure or surgery
H-FICB was guided by ultrasound before general anesthesia. The patient was supine. First, the probe is placed transversely above the groin. Then slide the probe up and down to reveal a clear image of the internal oblique and sartorius muscles. There is a bowtie-like iliac fascia space at the junction of these two muscles. After the scanning, the needle was inserted behind the probe with the tip pointed to the ventral side under the guidance of real-time ultrasound; the tip passed through the skin into the iliac fascia space and advanced to the inguinal ligament. After no blood was extracted, 1 ~ 2 ml of normal saline was firstly injected to determine whether the tip position was correct. If the needle tip was correctly positioned, 0.375% ropivacaine 30 mL of local anesthetic was injected. The H-FICB was performed under ultrasound guidance by the same anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Group A: H-FICB under ultrasound guidance before general anesthesia | Experimental | Group A was subjected to a high fascia iliaca compartment block under ultrasound guidance before general anesthesia. Receives: Procedure: ultrasound-guided high fascia iliaca compartment block |
| Group B: FBC combined with SBC under ultrasound guidance before general anesthesia | No intervention | Group B was subjected to a femoral nerve block combined with a sciatic nerve block under ultrasound guidance before general anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mini-mental State Examination
The mini-mental State Examination is effective as a screening tool for cognitive impairment in older, community-dwelling, hospitalized, and institutionalized adults. Assessment of an older adult's cognitive function is best achieved when it is done routinely, systematically, and thoroughly. The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points), or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age.
Measured: one day before the operation.
Change from Baseline visual analogue scale
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 100. A higher score indicates greater pain intensity. Based on the distribution of pain Visual Analogue Scale scores in post-surgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain Visual Analogue Scale have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: 30 minutes after extubation and 6 hours and 12 hours
Secondary outcomes (1)
The effective times of patient-controlled intravenous analgesia
Change from Baseline patient-controlled intravenous analgesia
Measured: during 0-6 hours, 6-12 hours, and 12-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start5 Feb 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion5 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee DiseaseStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Zhang, Principal investigator, Ethics Committee of Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325827
- Sponsor's protocol ID
- 2022-K022
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 13 Apr 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided High Fascia Iliaca Compartment Block in Patients Undergoing Arthroscopic Knee Surgery: A Prospective, Double-Blind, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT05325827
- Acronym / sponsor ID
- 2022-K022
- Conditions
- Knee Disease, Delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 5 Feb 2023 (estimated)
- First posted
- 13 Apr 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.
Arthroscopic knee surgery is a minimally invasive operation. Postoperative pain usually occurs, especially within 24 hours after surgery, the incidence of pain can be more than 76%. Pain will affect the patient's emotions and life, cause adverse effects, and even lead to postoperative delirium. This study aimed to investigate the clinical effect of ultrasound-guided high fascia iliaca compartment block(H-FICB) in patients undergoing knee arthroscopy and to compare it with the normal method which is femoral nerve block combined with a sciatic nerve block to choose the better way. A double-blind, randomized controlled trial was conducted with 44 patients, aged 18-65 years, ASA I-III, who were scheduled to undergo arthroscopic knee surgery in our hospital were selected, the patients were divided into Group A and Group B by random number table method, with 22 patients in each group. Group A was subjected to the H-FICB under ultrasound guidance before general anesthesia, given 0.375% ropivacaine 30 ml. Group B received ultrasound-guided femoral nerve block combined with sciatic nerve block before general anesthesia, given 0.375% ropivacaine 30 ml.
The mini-mental State Examination was used to assess all the patients' primary cognitive status one day before surgery. The initial acting time and the degrees of sensory block and motor block were recorded after the nerve block was completed. Perioperative variables were recorded to be compared. The investigators used the visual analog scale to assess patients' pain degree with postoperative, recorded the occurrence of adverse events such as postoperative nausea and vomiting(PONV), delayed emergence from anesthesia, and respiratory depression. The confusion assessment method was used to assess whether patients experienced delirium.
Detailed description
- Study design and setting 44 patients undergoing arthroscopic knee surgery under general anesthesia, gender, aged 18-65 years, American Society of Anesthesiologists (ASA) physical status I-III. Exclusion criteria: MMSE of 1 day before surgery < 27, communication and dysfunction (e.g., vision, hearing), cerebrovascular history, local anesthetic allergy, opioid allergy, puncture site infection, abnormal clotting.
- Subjects Patients were allocated randomly to A group (the high fascia iliaca compartment block group) and B group (the femoral nerve block combined with sciatic nerve block group) according to a computer-generated random number table. All patients and an investigator who was responsible for follow-up during 48 postoperative hours were blinded to the randomization groups. In addition, during preoperative visits, the investigators instructed patients on how to use the patient-controlled intravenous analgesia (PCA) device for pain management, as well as how to use the visual analog scale to evaluate pain at rest and while coughing. All the bispectral index (BIS) value in the present study was maintained between 40 and 60 during surgery. All patients voluntarily signed informed consent.
- General anesthesia Patients were monitored by electrocardiogram, pulse oximetry, and non-invasive blood pressure (one measurement every 3 min) while entering the operation room. A radial artery catheter was also placed for invasive arterial pressure and blood gas monitoring. The induction of general anesthesia was performed intravenously with sufentanil 0.5 µg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Endotracheal intubation was performed with a double-lumen tube. Sevoflurane was used at a minimal alveolar concentration (MAC) of 0.8-1, remifentanil and propofol were used for the maintenance. Fluid management was at the discretion of the attending anaesthesiologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: H-FICB under ultrasound guidance before general anesthesia | Experimental | Procedure: ultrasound-guided high fascia iliaca compartment blockGroup A was subjected to a high fascia iliaca compartment block under ultrasound guidance before general anesthesia. |
| Group B: FBC combined with SBC under ultrasound guidance before general anesthesia | No intervention | –Group B was subjected to a femoral nerve block combined with a sciatic nerve block under ultrasound guidance before general anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 65 years male and female
- Scheduled for elective arthroscopic knee surgery
- The patients volunteered to participate in the study and signed the informed consent
Key exclusion criteria (6 listed)
- Preexisting neuropathy
- Coagulopathy
- Local skin infection
- Hepatic, renal, or cardiorespiratory failure
- Local anesthetic allergy
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 |
|---|---|---|
| ultrasound-guided high fascia iliaca compartment blockH-FICB was guided by ultrasound before general anesthesia. The patient was supine. First, the probe is placed transversely above the groin. Then slide the probe up and down to reveal a clear image of the internal oblique and sartorius muscles. There is a bowtie-like iliac fascia space at the junction of these two muscles. After the scanning, the needle was inserted behind the probe with the tip pointed to the ventral side under the guidance of real-time ultrasound; the tip passed through the skin into the iliac fascia space and advanced to the inguinal ligament. After no blood was extracted, 1 ~ 2 ml of normal saline was firstly injected to determine whether the tip position was correct. If the needle tip was correctly positioned, 0.375% ropivacaine 30 mL of local anesthetic was injected. The H-FICB was performed under ultrasound guidance by the same anesthesiologist. | Procedure or surgery | Group A: H-FICB under ultrasound guidance before general anesthesia |
Primary outcome
The mini-mental State Examination
Time frame: one day before the operation.
The mini-mental State Examination is effective as a screening tool for cognitive impairment in older, community-dwelling, hospitalized, and institutionalized adults. Assessment of an older adult's cognitive function is best achieved when it is done routinely, systematically, and thoroughly. The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points), or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age.
Change from Baseline visual analogue scale
Time frame: 30 minutes after extubation and 6 hours and 12 hours
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 100. A higher score indicates greater pain intensity. Based on the distribution of pain Visual Analogue Scale scores in post-surgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain Visual Analogue Scale have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
1 secondary outcome
The effective times of patient-controlled intravenous analgesia
Time frame: during 0-6 hours, 6-12 hours, and 12-24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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.
Tao Zhang principal investigator
Ethics Committee of Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided high fascia iliaca compartment block in people with Knee Disease and Delirium, run by Affiliated Hospital of Nantong University 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 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: status not confirmed, as of the sponsor's last update on 13 Apr 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 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?
Contact Xingguo Xu, Dr (18621526251, xxgtdfy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mini-mental State Examination (time frame: one day before the operation.). The study lists 2 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 13 Apr 2022.