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

NCT05533970 | Completed

• 1 other identifier: 2022-K023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Disease; Quality of Recovery

Keywords

modified fascia iliaca compartment block; visual analogue scale(VAS) score

Outcome Measures

Primary Outcomes (2)

• 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, 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).

  30 minutes after extubation and 6 hours and 12 hours

• cumulative 24-hour postoperative opioid consumption

  cumulative 24-hour postoperative opioid consumption

  24 hours after surgery

Secondary Outcomes (1)

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

  three month after the operation

Study Arms (3)

0.375% ropivacaine+0.5ug/kg Dexmedetomidine 30 ml

EXPERIMENTAL

H-FICB under ultrasound guidance before general anesthesia, given 0.375% ropivacaine+0.5ug/kg Dexmedetomidine 30 ml

Procedure: ultrasound-guided high fascia iliaca compartment block

0.375% ropivacaine+1ug/kg Dexmedetomidine 30 ml

EXPERIMENTAL

H-FICB under ultrasound guidance before general anesthesia, given 0.375% ropivacaine+1ug/kg Dexmedetomidine 30 ml

Procedure: ultrasound-guided high fascia iliaca compartment block

0.375% ropivacaine+0.25ug/kg Dexmedetomidine 30 ml

EXPERIMENTAL

H-FICB under ultrasound guidance before general anesthesia, given 0.375% ropivacaine+0.25ug/kg Dexmedetomidine 30 ml

Procedure: ultrasound-guided high fascia iliaca compartment block

Interventions

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.

0.375% ropivacaine+0.25ug/kg Dexmedetomidine 30 ml; 0.375% ropivacaine+0.5ug/kg Dexmedetomidine 30 ml; 0.375% ropivacaine+1ug/kg Dexmedetomidine 30 ml

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Preexisting neuropathy Coagulopathy Local skin infection Hepatic, renal, or cardiorespiratory failure Local anesthetic allergy Pregnancy

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 0513, China

Location

Study Officials

• Tao Zhang

  Ethics Committee of Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 9, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 2, 2023
• Last Updated: July 20, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)