Postoperative AnalgesiaNCT06598852
To Compare the Analgesic Effects of Different Nerve Block Analgesia Methods in Thoracoscopic Surgery
A study testing TPVB group, ESPB group and TPVB combined ESPB group in people with Postoperative Analgesia, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
Comparison of analgesic effects of ultrasound-guided thoracic paravertebral block, erector spinae muscle block, thoracic paravertebral block combined with erector spinae muscle block, and intercostal nerve block in thoracoscopic surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- TPVB group, ESPB group and TPVB combined ESPB group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2024to 20 Jan 2025
- 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
- (1) American Society of Anesthesiologists (ASA) Grade I-II; (2) Age: 18-70 years old (3) double-hole thoracic surgery was performed; (4) Agree to participate in this study and sign the informed consent.
Who cannot join
- (1) People who are allergic to anesthetics used in this study; (2) Patients with coagulation disorders (3) patients with severe heart disease, liver or renal insufficiency; (4) have a history of chronic pain or chronic opioid users (5) have a co-existing mental illness and are not fully capable of cooperating
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000
Zhuo Liu, +86-5908581, liuzhuo2011@yeah.net
About this study
Official title: Comparison of Analgesic Effects of Ultrasound-guided Thoracic Paravertebral Block, Erector Spinae Muscle Block, Thoracic Paravertebral Block Combined with Erector Spinae Muscle Block, and Intercostal Nerve Block in Thoracoscopic Surgery
Comparison of analgesic effects of ultrasound-guided thoracic paravertebral block, erector spinae muscle block, thoracic paravertebral block combined with erector spinae muscle block, and intercostal nerve block in thoracoscopic surgery
Read the detailed description
120 patients undergoing elective thoracoscopic surgery were randomly divided into ESPB group (E group, n=30), TPVB group (T group, n=30), ESPB combine with TPVB group (ET group, n=30), ICNB group (I group, n=30). Patients in ESPB group underwent erector spinal block under ultrasound after anesthesia induction; Patients in TPVB group received thoracic paravertebral nerve block after anesthesia induction; Patients in ESPB group combined with TPVB group received thoracic paravertebral nerve block combined with erectoralis muscle block after anesthesia induction; Patients in INB group received intraoperative intercostal nerve block by the operator. All groups of patients received postoperative controlled intravenous analgesia (PCIA). Visual analogue scale (VAS) was used to evaluate the degree of pain 1h (T1), 24h (T2) and 48h (T3) after surgery. The mean arterial pressure (MAP), heart rate at T1-T3 were recorded, as well as the number of effective analgesic pump compression, the amount of sufentanil and the number of relief analgesia within 48h after surgery. The occurrence of postoperative adverse reactions such as nausea, vomiting, dizziness, retention time of thoracic drainage tube, postoperative hospital stay and postoperative pulmonary complications (pneumonia, atelectasis, pleural effusion, respiratory failure, etc.) were recorded.
- Conditions
- Postoperative Analgesia
- Being tested
- TPVB group, ESPB group, TPVB combined ESPB group, ICNB group
- Keywords
- thoracic paravertebral nerve block, erectoralis muscle block, intercostal nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPVB groupOther
Patients undergoing thoracoscopic surgery underwent general anesthesia and patients in TPVB Group received thoracic paravertebral nerve block with 0.33% ropivacaine 30ml under ultrasound guidance after anesthesia induction for postoperative analgesia.
ESPB groupOther
Patients undergoing thoracoscopic surgery underwent general anesthesia and patients in ESPB Group received erector spinae muscle block with 0.33% ropivacaine 30ml under ultrasound guidance after anesthesia induction for postoperative analgesia.
TPVB combined ESPB groupOther
Patients undergoing thoracoscopic surgery underwent general anesthesia and patients in TPVB combined ESPB group received thoracic paravertebral block combined with erector spinae muscle block with 0.33% ropivacaine 30ml under ultrasound guidance after anesthesia induction for postoperative analgesia.
ICNB groupOther
Patients undergoing thoracoscopic surgery underwent general anesthesia and patients in ICNB Group received intercostal nerve block for postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| TPVB group | Experimental | Ultrasound-guided thoracic paravertebral nerve block was used for postoperative analgesia after thoracic surgery Receives: Other: TPVB group |
| ESPB group | Experimental | Ultrasound-guided erector spinae muscle block was used for postoperative analgesia after thoracic surgery Receives: Other: ESPB group |
| TPVB combined ESPB group | Experimental | Ultrasound-guided thoracic paravertebral nerve block combined with erector spinae muscle block was used for postoperative analgesia after thoracic surgery Receives: Other: TPVB combined ESPB group |
| ICNB group | Experimental | Intercostal nerve block was used for postoperative analgesia after thoracic surgery Receives: Other: ICNB group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Visual analogue scale (VAS) was used to evaluate the degree of pain 1h (T1), 24h (T2) and 48h (T3) after surgery, the number of effective analgesic pump compressions and the number of remedial analgesia within 48h after surgery.
Measured: 48 hours after surgery
Secondary outcomes (1)
Incidence of postoperative complications
Mean arterial pressure (MAP), heart rate, postoperative nausea, vomiting, dizziness and other adverse reactions at T1-T3, retention time of thoracic drainage tube, and postoperative pulmonary complications (pneumonia, atractasis, pleural effusion, respiratory failure, etc.)
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024
- Primary completion20 Nov 2024 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zhuo Liu, Study director, The First hosptial of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598852
- Sponsor's protocol ID
- liuzhuo
- Status last verified
- Aug 2024
- First submitted
- 12 Sep 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Effects of Ultrasound-guided Thoracic Paravertebral Block, Erector Spinae Muscle Block, Thoracic Paravertebral Block Combined with Erector Spinae Muscle Block, and Intercostal Nerve Block in Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT06598852
- Acronym / sponsor ID
- liuzhuo
- Conditions
- Postoperative Analgesia
- Keywords
- thoracic paravertebral nerve block, erectoralis muscle block, intercostal nerve block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 19 Sep 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.
Comparison of analgesic effects of ultrasound-guided thoracic paravertebral block, erector spinae muscle block, thoracic paravertebral block combined with erector spinae muscle block, and intercostal nerve block in thoracoscopic surgery
Detailed description
120 patients undergoing elective thoracoscopic surgery were randomly divided into ESPB group (E group, n=30), TPVB group (T group, n=30), ESPB combine with TPVB group (ET group, n=30), ICNB group (I group, n=30). Patients in ESPB group underwent erector spinal block under ultrasound after anesthesia induction; Patients in TPVB group received thoracic paravertebral nerve block after anesthesia induction; Patients in ESPB group combined with TPVB group received thoracic paravertebral nerve block combined with erectoralis muscle block after anesthesia induction; Patients in INB group received intraoperative intercostal nerve block by the operator. All groups of patients received postoperative controlled intravenous analgesia (PCIA). Visual analogue scale (VAS) was used to evaluate the degree of pain 1h (T1), 24h (T2) and 48h (T3) after surgery. The mean arterial pressure (MAP), heart rate at T1-T3 were recorded, as well as the number of effective analgesic pump compression, the amount of sufentanil and the number of relief analgesia within 48h after surgery. The occurrence of postoperative adverse reactions such as nausea, vomiting, dizziness, retention time of thoracic drainage tube, postoperative hospital stay and postoperative pulmonary complications (pneumonia, atelectasis, pleural effusion, respiratory failure, etc.) were recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TPVB group | Experimental | Other: TPVB groupUltrasound-guided thoracic paravertebral nerve block was used for postoperative analgesia after thoracic surgery |
| ESPB group | Experimental | Other: ESPB groupUltrasound-guided erector spinae muscle block was used for postoperative analgesia after thoracic surgery |
| TPVB combined ESPB group | Experimental | Other: TPVB combined ESPB groupUltrasound-guided thoracic paravertebral nerve block combined with erector spinae muscle block was used for postoperative analgesia after thoracic surgery |
| ICNB group | Experimental | Other: ICNB groupIntercostal nerve block was used for postoperative analgesia after thoracic surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) American Society of Anesthesiologists (ASA) Grade I-II; (2) Age: 18-70 years old (3) double-hole thoracic surgery was performed; (4) Agree to participate in this study and sign the informed consent.
Key exclusion criteria (1 listed)
- (1) People who are allergic to anesthetics used in this study; (2) Patients with coagulation disorders (3) patients with severe heart disease, liver or renal insufficiency; (4) have a history of chronic pain or chronic opioid users (5) have a co-existing mental illness and are not fully capable of cooperating
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 |
|---|---|---|
| TPVB groupPatients undergoing thoracoscopic surgery underwent general anesthesia and patients in TPVB Group received thoracic paravertebral nerve block with 0.33% ropivacaine 30ml under ultrasound guidance after anesthesia induction for postoperative analgesia. | Other | TPVB group |
| ESPB groupPatients undergoing thoracoscopic surgery underwent general anesthesia and patients in ESPB Group received erector spinae muscle block with 0.33% ropivacaine 30ml under ultrasound guidance after anesthesia induction for postoperative analgesia. | Other | ESPB group |
| TPVB combined ESPB groupPatients undergoing thoracoscopic surgery underwent general anesthesia and patients in TPVB combined ESPB group received thoracic paravertebral block combined with erector spinae muscle block with 0.33% ropivacaine 30ml under ultrasound guidance after anesthesia induction for postoperative analgesia. | Other | TPVB combined ESPB group |
| ICNB groupPatients undergoing thoracoscopic surgery underwent general anesthesia and patients in ICNB Group received intercostal nerve block for postoperative analgesia. | Other | ICNB group |
Primary outcome
Postoperative pain score
Time frame: 48 hours after surgery
Visual analogue scale (VAS) was used to evaluate the degree of pain 1h (T1), 24h (T2) and 48h (T3) after surgery, the number of effective analgesic pump compressions and the number of remedial analgesia within 48h after surgery.
1 secondary outcome
Incidence of postoperative complications
Time frame: 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 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.
Zhuo Liu study director
The First hosptial of Qinhuangdao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TPVB group, ESPB group and TPVB combined ESPB group in people with Postoperative Analgesia, run by The First Hospital of Qinhuangdao 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 1 inclusion and 1 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 2 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ximing Qi (+86-13731777660, qhdddyyykyc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score (time frame: 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 2 Dec 2024.