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

G

General Hospital of Ningxia Medical University

Status

Enrolling

Conditions

Postoperative Pain

Treatments

Procedure: Sacral canal block combined with general anesthesia
Procedure: Simple general anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT07064434
Wenxuan Ma-2025-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment

80 estimated patients

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

General anesthesia group(NCB Group)
Active Comparator group
Description:
Conventional general anesthesia was adopted, and laryngeal mask general anesthesia was only administered to the patient.
Treatment:
Procedure: Simple general anesthesia
Sacral canal block + General anesthesia group (CB group)
Experimental group
Description:
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.
Treatment:
Procedure: Sacral canal block combined with general anesthesia

Trial contacts and locations

1

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Central trial contact

Xinli Ni, MD; Wenxuan Ma

Data sourced from clinicaltrials.gov

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