NCT06433089

Brief Summary

To retrospectively analyze the intraoperative and postoperative status of patients with hypertrophic cardiomyopathy undergoing TA-BSM, and to estimate whether paravertebral nerve block can improve postoperative pain for these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 11, 2024

Last Update Submit

May 25, 2024

Conditions

Nerve BlockTransapical Beating-heart Septal Myectomy

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    Cumulative morphine consumption

    During the first 48 hours after surgery

Secondary Outcomes (10)

  • Postoperative pain score 1

    24 hours after surgery and and 48 hours after surgery

  • Postoperative pain score 2

    Day 7 after surgery and month 3 after surgery

  • Physical recovery after surgery

    Day 7 after surgery

  • Complications

    24 hours and 48 hours after surgery

  • Perioperative information 1

    Immediately after the surgery

  • +5 more secondary outcomes

Study Arms (2)

group GA+PVB

The patients received General Anesthesia(GA) combined with Paravertebral Block(PVB).

Procedure: Thoracic paravertebral block

group GA only

The patients received general anesthesia only.

Interventions

Thoracic paravertebral blockPROCEDURE

Thoracic paravertebral block was performed before surgery

group GA+PVB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The information of all patients with hypertrophic cardiomyopathy undergoing TA-BSM in our hospital from April 2023 to September 2023 was extracted and screened according to the inclusion criteria and exclusion criteria.

You may qualify if:

  • Age 18\~75 years
  • American society of anesthesiologists classification II-III
  • Elective TA-BSM was performed

You may not qualify if:

  • Underwent multiple surgical procedures or required cardiopulmonary bypass assistance
  • Combined other function decompensation disease
  • Patients with incomplete medical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University

Wuhan, Hubei, 430030, China

Location

Study Officials

  • Wenlong Yao

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2024

First Posted

May 29, 2024

Study Start

April 1, 2023

Primary Completion

September 30, 2023

Study Completion

April 30, 2024

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations

CN(1)