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NCT Number: NCT07064434

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General hospital of Ningxia medical university

Yinchuan, Ningxia, China

Location status: Recruiting

Location contact

Xinli Ni, MD

CONTACT

[email protected]

86-0951-6743252

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Sacral canal block combined with general anesthesia

Procedure

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

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.

Primary outcomes

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

    Time frame: during surgery

    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.

Secondary outcomes

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

    Time frame: during surgery

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

  2. Peripheral perfusion index

    Time frame: during surgery

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

  3. heart rate(times/minute)

    Time frame: during surgery

    The heart rate of the patients during the operation.

  4. Intraoperative blood loss（Milliliters）

    Time frame: Day 1

    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.

  5. The cumulative dosage of anesthetic drugs used

    Time frame: Day 1

    Compare the cumulative dosage of anesthetic drugs used during the operation in the two groups, whether other vasoactive drugs were used, and record the total fluid input volume during the operation in the two groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenxuan Ma

CONTACT

[email protected]

18295009975

Xinli Ni, MD

CONTACT

[email protected]

13909586966

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

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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