Postoperative Pain for Patients After TA-BSM

Nerve Block Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06433089
• Other study ID #: TJMZK230601
• Status: Completed
• Start date: April 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: April 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Block
• Pain, Postoperative

Intervention

Procedure:
• Thoracic paravertebral block
Thoracic paravertebral block was performed before surgery

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wenlong Yao (101480)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Cumulative morphine consumption	During the first 48 hours after surgery
Secondary	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
Secondary	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
Secondary	Physical recovery after surgery	Quality of recovery(Rating from 0 [very poor] to 150 [excellent])	Day 7 after surgery
Secondary	Complications	The incidence of nausea and vomiting	24 hours and 48 hours after surgery
Secondary	Perioperative information 1	The usage of analgesic drug	Immediately after the surgery
Secondary	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
Secondary	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
Secondary	Perioperative information 4	Duration of anesthesia	Immediately after the surgery
Secondary	Postoperative information 1	Extubation time	Postoperative in 24 hours
Secondary	Postoperative information 2	The usage of analgesic drug	Postoperative in 48 hours