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NCT Number: NCT05533970

Ultrasound-guided H-FICB for Arthroscopic Knee Surgery： What is the Optimal Dose of Dexmedetomidine?

Total knee replacement (TKR) is among the most commonly performed orthopedic procedures, and a six-fold increase in the number of TKR cases world-wide is projected within a decade as the aging of the populations . As the number of the TKR procedures increases, various approaches increasing the satisfaction and comfort of the patient and the surgeon are of interest in order to provide improved pain management, in-hospital stay, and recovery with the development of modern anesthesiology and pain management techniques.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+0.5ug/kg Dexmedetomidine 30 ml. Group B was subjected to the H-FICB under ultrasound guidance before general anesthesia, given 0.375% ropivacaine+1ug/kg Dexmedetomidine 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.

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Key information

Conditions

Knee Disease Quality of Recovery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 0513, China

About this study

  • 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: 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 Modified Fascia Iliaca Compartment block+0.5ug/kg Dexmedetomidine ) and B group (tthe Modified Fascia Iliaca Compartment block+1ug/kg Dexmedetomidine) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound-guided high fascia iliaca compartment block

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.

Primary outcomes

  1. 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, who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain Numerical Rating 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).

  2. cumulative 24-hour postoperative opioid consumption

    Time frame: 24 hours after surgery

    cumulative 24-hour postoperative opioid consumption

Secondary outcomes

  1. The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale

    Time frame: three month after the operation

    During the patients' visits to the pain clinic in the third and sixth months after surgery, an untrained physician unknowingly assessed them. The assessment included evaluating pain intensity, nature, duration, aggravating and mitigating factors, and analgesic medication. The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale was used as the assessment tool to evaluate chronic neuropathic pain in this study.

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

Ultrasound-guided Modified Fascia Iliaca Compartment Nerve Block for Arthroscopic Knee Surgery： What is the Optimal Dose of Dexmedetomidine?

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 9, 2022
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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