Skip to content

Efficacy and safety of high iliac fascia block combined with MAC anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR)

Efficacy and safety of high iliac fascia block combined with MAC anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040876
Enrollment
Unknown
Registered
2020-12-12
Start date
2020-12-08
Completion date
Unknown
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic stenosis

Interventions

The experimental group:received ultrasound-guided iliac fascia block combined with MAC anesthesia
The control group:received MAC anesthesia only

Sponsors

General Hospital of the Northern Theater of the Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1) New York Heart function grade III to IV; 2) Selective transcatheter aortic valve replacement; 3) Transcatheter cardiac surgery for the first time; 4) Informed consent has been signed.

Exclusion criteria

Exclusion criteria: 1) Emergency surgery; 2) Severe neurological symptoms such as stroke with sequelae; 3) Hemodynamic instability was defined as systolic blood pressure < 90mmHg; 4) Pulmonary disease with airway disorders, such as apnea syndrome; 5) Aortic balloon pump or ventricular assist device was placed before operation; 6) Severe liver and kidney dysfunction before operation (dialysis patients with chronic renal failure or chronic liver disease patients with child grade B or above); 7) Severe systemic infection; 8) There was infection at the nerve block site; 9) History of local anesthetic allergy; 10) Patients cannot cooperate with research, such as language understanding, mental illness, etc.; 11) Participated in other clinical trials within 3 months prior to inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Intraoperative sufentanil use rate and total amount;Total use of propofol during operation;Respiratory depression related events: SpO2, nasopharynx airway implantation rate;Hemodynamic indexes: HR, BP, MAP;Usage rate and total amount of vasoactive drugs during operation;Usage rate and total amount of postoperative adjuvant analgesics;Postoperative pain score, patient and surgeon satisfaction;

Secondary

MeasureTime frame
Postoperative ICU stay time;Incidence of adverse reactions (such as nausea / vomiting, puncture site infection / bleeding, delirium / stroke;Incidence of postoperative cardiac block;Incidence of acute kidney injury;Postoperative hospital stay;Incidence of severe cardiovascular and cerebrovascular events (MACCE) 30 days after operation;Incidence of chronic pain and its impact on daily life 30 days after operation;Incidence of neuropathic pain 30 days after operation;Readmission rate 30 days after operation;The mortality rate was 30 days after operation;One year mortality after operation;

Countries

China

Contacts

Public ContactSun Yingjie

General Hospital of the Northern Theater of the Chinese People's Liberation Army

sunyingjie9@hotmail.com+86 17790993787

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026