Thoracoscopic SurgeryNCT05538429
Comparison of Analgesic Effect and Postoperative Recovery of SAPB Combined With ESPB and TPB After Thoracoscopic Surgery
A study testing erector spinal plane combined with serratus anterior plane block in people with Thoracoscopic Surgery and Nerve Block, run by Zhangyi at 1 site in China.
Trial summary
After thoracoscopic surgery, patients still face moderate to severe pain. How to effectively control pain and promote postoperative recovery of patients is a challenging problem. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thoracoscopic Surgery, Nerve Block
- What is being tested?
- erector spinal plane combined with serratus anterior plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Nov 2022
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American ASA Grade I-III;
- Age: 18 ~ 70 years old;
- 3 BMI 19 ~ 28kg/m2;
- 4. Patients with elective thoracoscopic partial pneumonectomy under general anesthesia;
- 5 Informed Consent has been signed.
Who cannot join
- Use opioid analgesics on a daily basis or have a history of opioid abuse;
- History of ipsilateral thoracotomy;
- Allergic to any of the drugs used in the study, or have a history of drug allergy;
- Mental or nervous system diseases, motor or sensory deficits;
- 5 there is coagulation dysfunction;
- 6. Cognitive dysfunction, unable to cooperate with research;
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- 7. Severe renal, hepatic or cardiac dysfunction;
- 8. Chest wall and spine trauma, infection, deformity and other cases where nerve block cannot be performed;
- 9. Participated in other clinical trials within the 3 months prior to study inclusion;
- 10. Investigators consider other reasons unsuitable for clinical trial participants;
- 11. Patients refuse to participate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.
Wuhan, Hubei, 430030
Yi Zhang, 13986039131, doc_zhang18@163.com
About this study
Official title: Comparison of Analgesic Effect and Postoperative Recovery of Serratus Anterior Plane Block Combined With Erector Spinae Plane Block and Thoracic Paravertebral Block After Thoracoscopic Surgery
After thoracoscopic surgery, patients still face moderate to severe pain. How to effectively control pain and promote postoperative recovery of patients is a challenging problem. Thoracic paraspinal block is effective in controlling pain after thoracoscopic surgery, but it also carries the risk of difficulty in operation and puncture of the pleura. In recent years, erector spinal plane block and serratus anterior plane block have been used for postoperative analgesia after thoracoscopic surgery. The purpose of this study was to explore whether erector spinal plane combined with serratus anterior plane block can replace thoracic paravertebral block and provide a more complete analgesia after thoracoscopic surgery. Therefore, this study is of great clinical significance.
Read the detailed description
In a double-blind randomized controlled study, investigators allocated 92 patients undergoing VATS to either SAPB Combined With ESPB or TPB, with both groups receiving otherwise standardized treatment, including multimodal analgesia. The primary outcome was 24-hr opioid consumption. Secondary outcomes included the number of survival analgesia at 1, 2, 4, 8, and 24 hours postoperatively ,VAS scores was assessed during resting and coughing statuses at 1, 2, 4, 8, and 24 hours postoperatively, pulmonary function indexes before and 1, 4, 24 hours after surgery , QOR-15 scores before and 24 hours after surgery, postoperative complications and recovery time nodes drainage tube removal time, discharge time.
- Conditions
- Thoracoscopic Surgery, Nerve Block
- Being tested
- erector spinal plane combined with serratus anterior plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinal plane combined with serratus anterior plane blockProcedure or surgery
Also called thoracic paravertebral block
The experimental group received ultrasound-guided erector spinal block combined with serratus anterior plane block, and erector spinal block was performed at the T5 and T7 levels with 10ml 0.4% ropivacaine for each level, and 20ml 0.4% ropivacaine for serratus anterior plane block. The control group received ultrasound-guided thoracic paravertebral block at T5 and T7 levels, respectively, with 20ml 0.4% ropivacaine at each level.
| Study group | Role | What they receive |
|---|---|---|
| ESPB&SAPB | Experimental | erector spinal plane block combined with serratus anterior plane block Receives: Procedure: erector spinal plane combined with serratus anterior plane block |
| TPVB | Active comparator | thoracic paravertebral block Receives: Procedure: erector spinal plane combined with serratus anterior plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose of opioids used
dosage of analgesic pump
Measured: 24 hours after surgery
Secondary outcomes (6)
The dose of opioids used
dosage of analgesic pump
Measured: 1hour, 2hours, 4hours, 8hours and 48hours postoperatively after surgery
The number of survival analgesia
times of rescue analgesia
Measured: 1hour, 2hours, 4hours, 8hours, 24hours and 48hours after surgery
VAS scores at resting and coughing state
visual analog pain scale
Measured: 1hour, 2hours, 4hours, 8hours, 24hours and 48hours after surgery
pulmonary function indexes
FVC (L)
Measured: Preoperative, postoperative 1hour, postoperative 4hours and postoperative 24hours
QOR-15 scores
The highest score is 150,the lowest score is 0. The higher the score, the better off the patient was.
Measured: before and 24 hours after surgery
Postoperative complications and recovery time nodes
drainage tube removal time, length of stay, etc.
Measured: follow up patients for an average of half a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Jun 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoscopic SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhangyi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhangyi, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538429
- Sponsor's protocol ID
- 1000012129
- Status last verified
- Sep 2022
- First submitted
- 27 Jan 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Effect and Postoperative Recovery of Serratus Anterior Plane Block Combined With Erector Spinae Plane Block and Thoracic Paravertebral Block After Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT05538429
- Acronym / sponsor ID
- 1000012129
- Conditions
- Thoracoscopic Surgery, Nerve Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- ZhangyiUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 13 Sep 2022 (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.
After thoracoscopic surgery, patients still face moderate to severe pain. How to effectively control pain and promote postoperative recovery of patients is a challenging problem. Thoracic paraspinal block is effective in controlling pain after thoracoscopic surgery, but it also carries the risk of difficulty in operation and puncture of the pleura. In recent years, erector spinal plane block and serratus anterior plane block have been used for postoperative analgesia after thoracoscopic surgery. The purpose of this study was to explore whether erector spinal plane combined with serratus anterior plane block can replace thoracic paravertebral block and provide a more complete analgesia after thoracoscopic surgery. Therefore, this study is of great clinical significance.
Detailed description
In a double-blind randomized controlled study, investigators allocated 92 patients undergoing VATS to either SAPB Combined With ESPB or TPB, with both groups receiving otherwise standardized treatment, including multimodal analgesia. The primary outcome was 24-hr opioid consumption. Secondary outcomes included the number of survival analgesia at 1, 2, 4, 8, and 24 hours postoperatively ,VAS scores was assessed during resting and coughing statuses at 1, 2, 4, 8, and 24 hours postoperatively, pulmonary function indexes before and 1, 4, 24 hours after surgery , QOR-15 scores before and 24 hours after surgery, postoperative complications and recovery time nodes drainage tube removal time, discharge time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB&SAPB | Experimental | Procedure: erector spinal plane combined with serratus anterior plane blockerector spinal plane block combined with serratus anterior plane block |
| TPVB | Active comparator | Procedure: erector spinal plane combined with serratus anterior plane blockthoracic paravertebral block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- American ASA Grade I-III;
- Age: 18 ~ 70 years old;
- 3 BMI 19 ~ 28kg/m2;
- 4. Patients with elective thoracoscopic partial pneumonectomy under general anesthesia;
- 5 Informed Consent has been signed.
Key exclusion criteria (11 listed)
- Use opioid analgesics on a daily basis or have a history of opioid abuse;
- History of ipsilateral thoracotomy;
- Allergic to any of the drugs used in the study, or have a history of drug allergy;
- Mental or nervous system diseases, motor or sensory deficits;
- 5 there is coagulation dysfunction;
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 |
|---|---|---|
| erector spinal plane combined with serratus anterior plane blockAlso: thoracic paravertebral blockThe experimental group received ultrasound-guided erector spinal block combined with serratus anterior plane block, and erector spinal block was performed at the T5 and T7 levels with 10ml 0.4% ropivacaine for each level, and 20ml 0.4% ropivacaine for serratus anterior plane block. The control group received ultrasound-guided thoracic paravertebral block at T5 and T7 levels, respectively, with 20ml 0.4% ropivacaine at each level. | Procedure or surgery | ESPB&SAPB, TPVB |
Primary outcome
The dose of opioids used
Time frame: 24 hours after surgery
dosage of analgesic pump
6 secondary outcomes
The dose of opioids used
Time frame: 1hour, 2hours, 4hours, 8hours and 48hours postoperatively after surgery
The number of survival analgesia
Time frame: 1hour, 2hours, 4hours, 8hours, 24hours and 48hours after surgery
VAS scores at resting and coughing state
Time frame: 1hour, 2hours, 4hours, 8hours, 24hours and 48hours after surgery
pulmonary function indexes
Time frame: Preoperative, postoperative 1hour, postoperative 4hours and postoperative 24hours
QOR-15 scores
Time frame: before and 24 hours after surgery
Postoperative complications and recovery time nodes
Time frame: follow up patients for an average of half a month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spinal plane combined with serratus anterior plane block in people with Thoracoscopic Surgery and Nerve Block, run by Zhangyi 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang, Dr. (13986039131, doc_zhang18@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dose of opioids used (time frame: 24 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 13 Sep 2022.