Postoperative Pain for Patients After TA-BSM

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: Completed
• Conditions: Nerve Block; Transapical Beating-heart Septal Myectomy
• Intervention / Treatment: Procedure: Thoracic paravertebral block

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: Observational
• Enrollment (Actual): 197

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Morphine consumption	Cumulative morphine consumption	During the first 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score 1	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	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	Quality of recovery(Rating from 0 [very poor] to 150 [excellent])	Day 7 after surgery
Complications	The incidence of nausea and vomiting	24 hours and 48 hours after surgery
Perioperative information 1	The usage of analgesic drug	Immediately after the surgery
Perioperative information 2	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	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	Duration of anesthesia	Immediately after the surgery
Postoperative information 1	Extubation time	Postoperative in 24 hours
Postoperative information 2	The usage of analgesic drug	Postoperative in 48 hours

Collaborators and Investigators

• Sponsor: Wenlong Yao (101480)
• Investigators: Principal Investigator: Wenlong Yao, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: May 11, 2024
• First Submitted That Met QC Criteria: May 25, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 25, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID 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