## Protocol Section
### Identification Module
**NCT ID:** NCT06433089

**Brief Title:** Postoperative Pain for Patients After TA-BSM

**Official Title:** 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

#### Organization Study ID Info
**ID:** TJMZK230601
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2024-04-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-09-30

**Type:** ACTUAL

#### Start Date
**Date:** 2023-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Wenlong Yao (101480)

#### Responsible Party

**Investigator Affiliation:** Tongji Hospital

**Investigator Full Name:** Wenlong Yao (101480)

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Nerve Block

- Transapical Beating-heart Septal Myectomy

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 197

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Thoracic paravertebral block

**Label:** group GA+PVB

#### Arm Group 2

**Description:** The patients received general anesthesia only.

**Label:** group GA only

### Interventions

#### Intervention 1

**Arm Group Labels:**

- group GA+PVB

**Description:** Thoracic paravertebral block was performed before surgery

**Name:** Thoracic paravertebral block

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Cumulative morphine consumption

**Measure:** Morphine consumption

**Time Frame:** During the first 48 hours after surgery

#### Secondary Outcomes

**Description:** Visual Analogue Scale score(0-10 stands for the degree of pain, 0=no pain, 10=the worst pain ever)

**Measure:** Postoperative pain score 1

**Time Frame:** 24 hours after surgery and and 48 hours after surgery

**Description:** Brief Pain Inventory(The degree of pain \[0 no pain to 10 very painful\] and the impact of pain on daily life function \[0 no impact to 10 very impact\])

**Measure:** Postoperative pain score 2

**Time Frame:** Day 7 after surgery and month 3 after surgery

**Description:** Quality of recovery(Rating from 0 \[very poor\] to 150 \[excellent\])

**Measure:** Physical recovery after surgery

**Time Frame:** Day 7 after surgery

**Description:** The incidence of nausea and vomiting

**Measure:** Complications

**Time Frame:** 24 hours and 48 hours after surgery

**Description:** The usage of analgesic drug

**Measure:** Perioperative information 1

**Time Frame:** Immediately after the surgery

**Description:** Mean arterial blood pressure

**Measure:** 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

**Description:** Heart reat

**Measure:** 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

**Description:** Duration of anesthesia

**Measure:** Perioperative information 4

**Time Frame:** Immediately after the surgery

**Description:** Extubation time

**Measure:** Postoperative information 1

**Time Frame:** Postoperative in 24 hours

**Description:** The usage of analgesic drug

**Measure:** Postoperative information 2

**Time Frame:** Postoperative in 48 hours

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Wuhan

**Country:** China

**Facility:** Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University

**State:** Hubei

**Zip:** 430030

#### Overall Officials

**Official 1:**

**Affiliation:** Tongji Hospital

**Name:** Wenlong Yao

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10035

- Name: Hypertrophy

- Relevance: LOW

- As Found: Unknown

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Postoperative Pain

- ID: M12154

- Name: Cardiomyopathies

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
