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Completed

NCT Number: NCT06433089

Postoperative Pain for Patients After TA-BSM

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.

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Key information

Conditions

Nerve Block Transapical Beating-heart Septal Myectomy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracic Paravertebral Block

Procedure

Thoracic paravertebral block was performed before surgery

Primary outcomes

  1. Morphine consumption

    Time frame: During the first 48 hours after surgery

    Cumulative morphine consumption

Secondary outcomes

  1. 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)

  2. 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])

  3. Physical recovery after surgery

    Time frame: Day 7 after surgery

    Quality of recovery(Rating from 0 [very poor] to 150 [excellent])

  4. Complications

    Time frame: 24 hours and 48 hours after surgery

    The incidence of nausea and vomiting

  5. Perioperative information 1

    Time frame: Immediately after the surgery

    The usage of analgesic drug

  6. 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

  7. 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

  8. Perioperative information 4

    Time frame: Immediately after the surgery

    Duration of anesthesia

  9. Postoperative information 1

    Time frame: Postoperative in 24 hours

    Extubation time

  10. Postoperative information 2

    Time frame: Postoperative in 48 hours

    The usage of analgesic drug

Sponsors and collaborators

Lead sponsor

Wenlong Yao (101480)

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 29, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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