Nerve BlockNCT06433089
Postoperative Pain for Patients After TA-BSM
An observational study of Nerve Block and Transapical Beating-heart Septal Myectomy, run by Wenlong Yao (101480) at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nerve Block, Transapical Beating-heart Septal Myectomy
- What is being tested?
- Thoracic paravertebral block
- Type of treatment
- Surgery or procedure
- How many people
- 197 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age 18~75 years
- American society of anesthesiologists classification II-III
- Elective TA-BSM was performed
Who cannot join
- Underwent multiple surgical procedures or required cardiopulmonary bypass assistance
- Combined other function decompensation disease
- Patients with incomplete medical records
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University
Wuhan, Hubei, 430030
About this study
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
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.
Read the 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.
- Being tested
- Thoracic paravertebral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic paravertebral blockProcedure or surgery
Thoracic paravertebral block was performed before surgery
| Study group | Role | What they receive |
|---|---|---|
| group GA+PVB | The patients received General Anesthesia(GA) combined with Paravertebral Block(PVB). Receives: Procedure: Thoracic paravertebral block | |
| group GA only | The patients received general anesthesia only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Cumulative morphine consumption
Measured: During the first 48 hours after surgery
Secondary outcomes (10)
Postoperative pain score 1
Visual Analogue Scale score(0-10 stands for the degree of pain, 0=no pain, 10=the worst pain ever)
Measured: 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])
Measured: Day 7 after surgery and month 3 after surgery
Physical recovery after surgery
Quality of recovery(Rating from 0 [very poor] to 150 [excellent])
Measured: Day 7 after surgery
Complications
The incidence of nausea and vomiting
Measured: 24 hours and 48 hours after surgery
Perioperative information 1
The usage of analgesic drug
Measured: Immediately after the surgery
Perioperative information 2
Mean arterial blood pressure
Measured: 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
Measured: 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
Measured: Immediately after the surgery
Postoperative information 1
Extubation time
Measured: Postoperative in 24 hours
Postoperative information 2
The usage of analgesic drug
Measured: Postoperative in 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 Apr 2023
- Primary completion30 Sep 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenlong Yao (101480)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wenlong Yao (101480), Tongji Hospital
- Investigators
- Wenlong Yao, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433089
- Sponsor's protocol ID
- TJMZK230601
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06433089
- Acronym / sponsor ID
- TJMZK230601
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Wenlong Yao (101480)University, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group GA+PVB | – | Procedure: Thoracic paravertebral blockThe patients received General Anesthesia(GA) combined with Paravertebral Block(PVB). |
| group GA only | – | –The patients received general anesthesia only. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18~75 years
- American society of anesthesiologists classification II-III
- Elective TA-BSM was performed
Key exclusion criteria (3 listed)
- Underwent multiple surgical procedures or required cardiopulmonary bypass assistance
- Combined other function decompensation disease
- Patients with incomplete medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic paravertebral blockThoracic paravertebral block was performed before surgery | Procedure or surgery | group GA+PVB |
Primary outcome
Morphine consumption
Time frame: During the first 48 hours after surgery
Cumulative morphine consumption
10 secondary outcomes
Postoperative pain score 1
Time frame: 24 hours after surgery and and 48 hours after surgery
Postoperative pain score 2
Time frame: Day 7 after surgery and month 3 after surgery
Physical recovery after surgery
Time frame: Day 7 after surgery
Complications
Time frame: 24 hours and 48 hours after surgery
Perioperative information 1
Time frame: Immediately after the surgery
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
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
Perioperative information 4
Time frame: Immediately after the surgery
Postoperative information 1
Time frame: Postoperative in 24 hours
Postoperative information 2
Time frame: Postoperative in 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenlong Yao principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nerve Block and Transapical Beating-heart Septal Myectomy, run by Wenlong Yao (101480) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: During the first 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.