Postoperative Pain for Patients After TA-BSM

Completed

• Conditions: Transapical Beating-heart Septal Myectomy; Nerve Block
• Interventions: Procedure: Thoracic paravertebral block

• Registration Number: NCT06433089
• Lead Sponsor: Wenlong Yao (101480)

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.

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-09-30
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-11
• Study First Submitted QC: 2024-05-25
• Last Update Submitted: 2024-05-25
• Study First Posted: 2024-05-29
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group GA+PVB	Thoracic paravertebral block	The patients received General Anesthesia(GA) combined with Paravertebral Block(PVB).

Primary Outcome Measures

Name	Time	Method
Morphine consumption	During the first 48 hours after surgery	Cumulative morphine consumption

Secondary Outcome Measures

Name	Time	Method
Postoperative pain score 1	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)
Postoperative information 1	Postoperative in 24 hours	Extubation time
Perioperative information 1	Immediately after the surgery	The usage of analgesic drug
Perioperative information 4	Immediately after the surgery	Duration of anesthesia
Postoperative pain score 2	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 \[0 no impact to 10 very impact\])
Physical recovery after surgery	Day 7 after surgery	Quality of recovery(Rating from 0 \[very poor\] to 150 \[excellent\])
Complications	24 hours and 48 hours after surgery	The incidence of nausea and vomiting
Perioperative information 2	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
Perioperative information 3	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
Postoperative information 2	Postoperative in 48 hours	The usage of analgesic drug

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University; 🇨🇳 Wuhan, Hubei, China