Postoperative Pain for Patients After TA-BSM

May 25, 2024 updated by: Wenlong Yao (101480)

Effect of Thoracic Paravertebral Nerve Block on Postoperative Pain After Transapical Beating-heart Myectomy(TA-BSM) in Patients With Hypertrophic Obstructive Cardiomyopathy: a Retrospective Cohort Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Since conventional septal myectomy can be only assessed when the heart resumes beating, and the complications induced by cardiopulmonary bypass are inevitable, a novel transapical beating-heart septal myectomy (TA-BSM) has been invented, which provides real-time evaluation to guide resection while reducing surgical trauma. Postoperative pain after TA-BSM is unknown. Whether paravertebral nerve block can improve postoperative pain caused by TA-BSM is the objective of our study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
group GA+PVB
The patients received General Anesthesia(GA) combined with Paravertebral Block(PVB).
Procedure: Thoracic paravertebral block
Thoracic paravertebral block was performed before surgery
group GA only
The patients received general anesthesia only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: During the first 48 hours after surgery
Cumulative morphine consumption
During the first 48 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative pain score 1
Time Frame: 24 hours after surgery and and 48 hours after surgery
Visual Analogue Scale score(0-10 stands for the degree of pain, 0=no pain, 10=the worst pain ever)
24 hours after surgery and and 48 hours after surgery
Postoperative pain score 2
Time Frame: Day 7 after surgery and month 3 after surgery
Brief Pain Inventory(The degree of pain [0 no pain to 10 very painful] and the impact of pain on daily life function [0 no impact to 10 very impact])
Day 7 after surgery and month 3 after surgery
Physical recovery after surgery
Time Frame: Day 7 after surgery
Quality of recovery(Rating from 0 [very poor] to 150 [excellent])
Day 7 after surgery
Complications
Time Frame: 24 hours and 48 hours after surgery
The incidence of nausea and vomiting
24 hours and 48 hours after surgery
Perioperative information 1
Time Frame: Immediately after the surgery
The usage of analgesic drug
Immediately after the surgery
Perioperative information 2
Time Frame: P1= before induction, P2= 5 minutes after tracheal intubation, P3= before skin incision, P4= 5 minutes after skin incision, P5=5 minutes after placed the rib spreader
Mean arterial blood pressure
P1= before induction, P2= 5 minutes after tracheal intubation, P3= before skin incision, P4= 5 minutes after skin incision, P5=5 minutes after placed the rib spreader
Perioperative information 3
Time Frame: P1= before induction, P2= 5 minutes after tracheal intubation, P3= before skin incision, P4= 5 minutes after skin incision, P5=5 minutes after placed the rib spreader
Heart reat
P1= before induction, P2= 5 minutes after tracheal intubation, P3= before skin incision, P4= 5 minutes after skin incision, P5=5 minutes after placed the rib spreader
Perioperative information 4
Time Frame: Immediately after the surgery
Duration of anesthesia
Immediately after the surgery
Postoperative information 1
Time Frame: Postoperative in 24 hours
Extubation time
Postoperative in 24 hours
Postoperative information 2
Time Frame: Postoperative in 48 hours
The usage of analgesic drug
Postoperative in 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wenlong Yao (101480)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wenlong Yao, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TJMZK230601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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