Clinical trial NCT06433089: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nerve Block
Transapical Beating-heart Septal Myectomy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Morphine consumption
timeFrame: During the first 48 hours after surgery
Secondary outcomes:
measure: Postoperative pain score 1
timeFrame: 24 hours after surgery and and 48 hours after surgery
measure: Postoperative pain score 2
timeFrame: Day 7 after surgery and month 3 after surgery
measure: Physical recovery after surgery
timeFrame: Day 7 after surgery
measure: Complications
timeFrame: 24 hours and 48 hours after surgery
measure: Perioperative information 1
timeFrame: Immediately after the surgery
measure: Perioperative information 2
timeFrame: 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
measure: Perioperative information 3
timeFrame: 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
measure: Perioperative information 4
timeFrame: Immediately after the surgery
measure: Postoperative information 1
timeFrame: Postoperative in 24 hours
measure: Postoperative information 2
timeFrame: Postoperative in 48 hours
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wenlong Yao
role: PRINCIPAL_INVESTIGATOR
References: