Effect of Ultrasound-guided H-FICB in Patients Undergoing Arthroscopic Knee Surgery
Primary Purpose
Knee Disease, Delirium
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ultrasound-guided high fascia iliaca compartment block
Sponsored by
About this trial
This is an interventional treatment trial for Knee Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Preexisting neuropathy
- Coagulopathy
- Local skin infection
- Hepatic, renal, or cardiorespiratory failure
- Local anesthetic allergy
- Pregnancy
Sites / Locations
- Affiliated Hospital of Nantong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group A: H-FICB under ultrasound guidance before general anesthesia
Group B: FBC combined with SBC under ultrasound guidance before general anesthesia
Arm Description
Group A was subjected to a high fascia iliaca compartment block under ultrasound guidance before general anesthesia.
Group B was subjected to a femoral nerve block combined with a sciatic nerve block under ultrasound guidance before general anesthesia.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
The effective times of patient-controlled intravenous analgesia
Change from Baseline patient-controlled intravenous analgesia
Full Information
NCT ID
NCT05325827
First Posted
April 6, 2022
Last Updated
April 6, 2022
Sponsor
Affiliated Hospital of Nantong University
1. Study Identification
Unique Protocol Identification Number
NCT05325827
Brief Title
Effect of Ultrasound-guided H-FICB in Patients Undergoing Arthroscopic Knee Surgery
Official Title
Effect of Ultrasound-guided High Fascia Iliaca Compartment Block in Patients Undergoing Arthroscopic Knee Surgery: A Prospective, Double-Blind, Randomized, Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
February 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital of Nantong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Disease, Delirium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: H-FICB under ultrasound guidance before general anesthesia
Arm Type
Experimental
Arm Description
Group A was subjected to a high fascia iliaca compartment block under ultrasound guidance before general anesthesia.
Arm Title
Group B: FBC combined with SBC under ultrasound guidance before general anesthesia
Arm Type
No Intervention
Arm Description
Group B was subjected to a femoral nerve block combined with a sciatic nerve block under ultrasound guidance before general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided high fascia iliaca compartment block
Intervention Description
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.
Primary Outcome Measure Information:
Title
The mini-mental State Examination
Description
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.
Time Frame
one day before the operation.
Title
Change from Baseline visual analogue scale
Description
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).
Time Frame
30 minutes after extubation and 6 hours and 12 hours
Secondary Outcome Measure Information:
Title
The effective times of patient-controlled intravenous analgesia
Description
Change from Baseline patient-controlled intravenous analgesia
Time Frame
during 0-6 hours, 6-12 hours, and 12-24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Preexisting neuropathy
Coagulopathy
Local skin infection
Hepatic, renal, or cardiorespiratory failure
Local anesthetic allergy
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xingguo Xu, Dr
Phone
18621526251
Email
xxgtdfy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Zhang
Organizational Affiliation
Ethics Committee of Affiliated Hospital of Nantong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
0513
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingguo Xu
Phone
18621526251
Email
xxgtdfy@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Ultrasound-guided H-FICB in Patients Undergoing Arthroscopic Knee Surgery
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