Clinical trial NCT05325827: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Disease
Delirium
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 1. 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.
2. 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.
3. 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.

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

Primary outcomes:
measure: The mini-mental State Examination
timeFrame: one day before the operation.
measure: Change from Baseline visual analogue scale
timeFrame: 30 minutes after extubation and 6 hours and 12 hours
Secondary outcomes:
measure: The effective times of patient-controlled intravenous analgesia
timeFrame: during 0-6 hours, 6-12 hours, and 12-24 hours
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Ethics Committee of Affiliated Hospital of Nantong University
name: Tao Zhang
role: PRINCIPAL_INVESTIGATOR
References: