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

NCT07064434 | Recruiting DMC

• 1 other identifier: Wenxuan Ma-2025-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

Sacral canal block; Hip replacement; Postoperative rehabilitation

Outcome Measures

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.

  during surgery

Secondary Outcomes (5)

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

  during surgery

• Peripheral perfusion index

  during surgery

• heart rate(times/minute)

  during surgery

• Intraoperative blood loss（Milliliters）

  Day 1

• The cumulative dosage of anesthetic drugs used

  Day 1

Study Arms (2)

General anesthesia group(NCB Group)

ACTIVE COMPARATOR

Conventional general anesthesia was adopted, and laryngeal mask general anesthesia was only administered to the patient.

Procedure: Simple general anesthesia

Sacral canal block + General anesthesia group (CB group)

EXPERIMENTAL

Thirty minutes before the start of the operation, 30ML of the pre-prepared 0.375% ropivacaine was injected into the sacral canal under ultrasound guidance, and the diffusion of the local anesthetic in the sacral canal could be observed.

Procedure: Sacral canal block combined with general anesthesia

Interventions

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.

Sacral canal block + General anesthesia group (CB group)

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.

General anesthesia group(NCB Group)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General hospital of Ningxia medical university

Yinchuan, Ningxia, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Xinli Ni, MD

CONTACT

13909586966; xinlini6@nyfy.com.cn

Wenxuan Ma

CONTACT

18295009975; 769462442@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: July 14, 2025
• Study Start: November 1, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)