Effect of Ultrasound-guided H-FICB in Patients Undergoing Arthroscopic Knee Surgery

NCT ID: NCT05325827

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-05
• Study Completion Date: 2023-02-05

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.

Conditions

Knee Disease; Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A: H-FICB under ultrasound guidance before general anesthesia

Group A was subjected to a high fascia iliaca compartment block under ultrasound guidance before general anesthesia.

Group Type: EXPERIMENTAL

ultrasound-guided high fascia iliaca compartment block

Intervention Type: PROCEDURE

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.

Group B: FBC combined with SBC 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ultrasound-guided high fascia iliaca compartment block

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tao Zhang

Role: PRINCIPAL_INVESTIGATOR

Ethics Committee of Affiliated Hospital of Nantong University

Locations

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xingguo Xu, Dr

Role: CONTACT

xxgtdfy@163.com

18621526251

Facility Contacts

Xingguo Xu

Role: primary

xxgtdfy@163.com

18621526251

Other Identifiers

2022-K022

Identifier Type: -

Identifier Source: org_study_id