Sacral Canal Block for Hip Replacement the Efficacy and Safety of Controlled Intraoperative Hypotension

Официальное название

Sacral Canal Block for Hip Replacement the Efficacy and Safety of Controlled Intraoperative Hypotension:a Single-center, Prospective, Randomized Controlled Study

Обзор

To observe the efficacy and safety of sacral canal block in controlled blood pressure reduction during hip replacement in the elderly, and to provide a better option for controlled blood pressure reduction during clinical hip surgery.

Подробное описание

Confirm the effectiveness of sacral canal block in controlled blood pressure reduction during hip replacement surgery in the elderly.

The patient underwent sacral canal block 30 minutes before the operation. The time from the start of the block to achieving the target blood pressure for controlled blood pressure reduction, the duration of the target blood pressure, and the blood pressure variability at different time points were observed. The blood pressure variability was used to evaluate the effect of controlled blood pressure reduction during the operation, the intraoperative blood loss, and the surgeon's satisfaction. It has been confirmed that sacral canal block can effectively achieve the purpose of controlled blood pressure reduction in hip replacement surgery for the elderly.

Clarify the safety of sacral canal block for controlled hypotension in hip replacement surgery.

The patient underwent sacral canal block 30 minutes before the operation. Observe from the start of the block to the regression of the block plane, and the patient was lowered Limb tissue oxygen saturation, peripheral perfusion index, unexpected hypotension, heart rate variability, pulse oxygen saturation, and whether there are complications related to sacral canal block such as local anesthetic poisoning, general spinal anesthesia, regional nerve injury, epidural hematoma, puncture site infection, etc. Meanwhile, the general information of the patients was recorded, including the duration of the operation, the consumption of opioids during the operation, the postoperative pain score, the incidence of nausea and vomiting, and the recovery of sensorimotor sensation in the postoperative block plane regression of the patients, etc. It is clear that sacral canal block can be safely used for controlled blood pressure reduction during hip replacement surgery in the elderly.

Вмешательства

• Процедура Sacral canal block combined with general anesthesia
  Sacral canal block: The patient lies on their side, with the back perpendicular to the edge of the operating table. The knee joints of the lower limbs are flexed, the thighs are close to the abdomen, and the waist is arched backward as much as possible, resembling a "shrimp" shape. The space between the sacrum and coccyx of the patient (sacral hiatus) is fully exposed. By using a low-frequency probe (such as 2-5 MHZ), the strong echo of the sacrum, the low echo of the sacral canal, and the echo
• Процедура Simple general anesthesia
  General anesthesia: Midazolam (0.2mg/kg), sufentanil (0.2-0.4μg/kg), etomidate (0.15-0.3 mg/kg), and rocuronium (0.6 mg/kg) were induced. After the patient's muscles were completely relaxed, a laryngeal mask was placed. Connect the anesthesia machine and set the ventilator parameters: Vol.Mode, tidal volume 6-8ml/kg, frequency 10-14 times /min, inhalation-exhalation ratio 1:2, and maintain EtCO2 at 35-45mmHg during the operation. Propofol (4-12mg/kg/h) and remifentanil (0.05-2ug/kg/min) were mai

Первичные конечные точки

• The onset time for blood pressure to drop from the basal blood pressure to the controlled antihypertensive target value [Срок оценки: during surgery]

Вторичные конечные точки (5)

• Oxygen saturation of the lower extremity tissue on the healthy side（%） [Срок оценки: during surgery]
• Peripheral perfusion index [Срок оценки: during surgery]
• heart rate(times/minute) [Срок оценки: during surgery]
• Intraoperative blood loss（Milliliters） [Срок оценки: Day 1]
• The cumulative dosage of anesthetic drugs used [Срок оценки: Day 1]

Критерии участия

Критерии включения

• Over 45 years old;
• ASA Grade II - III;
• BMI 18-35kg/㎡;
• Agree to participate in this study and sign the informed consent form.

Критерии исключения

• Those who refuse to participate in the experiment;
• Those who suffer from language or hearing impairments and are unable to communicate;
• Those with contraindications for sacral canal block.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• General hospital of Ningxia medical university — Иньчуань

Идентификаторы

NCT: NCT07064434 · Wenxuan Ma-2025-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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