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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorGeneral Hospital of Ningxia Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Over 45 years old;

ASA Grade II - III;

BMI 18-35kg/㎡;

Agree to participate in this study and sign the informed consent form.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sacral canal block combined with general anesthesia

    Procedure/Surgery

    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 of the surrounding soft tissues can be clearly seen. At the located sacral hiatus, hold the puncture needle and slowly insert it perpendicularly to the skin. When the puncture needle passes through the sacrococcygeal ligament, there will be a distinct "breakthrough sensation", which indicates that the puncture needle has entered the sacral canal. The general depth of needle insertion is about 2 to 3cm. However, the specific depth varies depending on factors such as the patient's body type.

  • Simple general anesthesia

    Procedure/Surgery

    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 maintained. According to the operation course, rocuronium (0.15mg/kg) and sevoflurane inhalation (1% - 7%) could be administered at a single time. Anesthesiologists adjust the drug infusion rate based on the patient's hemodynamic indicators SBP, MAP, HR and clinical experience. When HR was less than 45 times /min during the operation, atropine was intravenously injected (0.25-0.5mg per time). When MAP is less than 55mmHg and lasts for more than 3 minutes, ephedrine (6-12mg each time) is given.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: General anesthesia group(NCB Group)Active comparator 1 intervention
Group B: Sacral canal block + General anesthesia group (CB group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The onset time for blood pressure to drop from the basal blood pressure to the controlled antihypertensive target value

The onset time of blood pressure change from the basal blood pressure to the controlled blood pressure reduction target value (systolic blood pressure lower than or equal to 90mmHg or MAP60-70mmHg), the maintenance time of the target blood pressure value, the blood pressure values at each time point, and the intraoperative blood loss.

Time frame
during surgery

Secondary outcomes

1

Oxygen saturation of the lower extremity tissue on the healthy side(%)

Oxygen saturation of the lower extremity tissue on the healthy side(%)

Time frame
during surgery
2

Peripheral perfusion index

The peripheral perfusion index (PI) of the patients during the operation.

Time frame
during surgery
3

heart rate(times/minute)

The heart rate of the patients during the operation.

Time frame
during surgery
4

Intraoperative blood loss(Milliliters)

Compare the intraoperative blood loss of the two groups: Total blood loss = Total blood volume of the human body × (before Hct - after Hct)/average Hct.

Time frame
Day 1

Other outcomes

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