- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06598852
To Compare the Analgesic Effects of Different Nerve Block Analgesia Methods in Thoracoscopic Surgery
November 28, 2024 updated by: The First Hospital of Qinhuangdao
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ximing Qi
- Phone Number: +86-13731777660
- Email: qhdddyyykyc@163.com
Study Contact Backup
- Name: Zhuo Liu
- Phone Number: +86-18330357618
- Email: liuzhuo2011@yeah.net
Study Locations
-
-
Hebei
-
Qinhuangdao, Hebei, China, 066000
- Recruiting
- First Hospital of Qinhuangdao
-
Contact:
- Zhuo Liu
- Phone Number: +86-5908581
- Email: liuzhuo2011@yeah.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- (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.
Exclusion Criteria:
- (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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TPVB group
Ultrasound-guided thoracic paravertebral nerve block was used for postoperative analgesia after thoracic surgery
|
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.
|
|
Experimental: ESPB group
Ultrasound-guided erector spinae muscle block was used for postoperative analgesia after thoracic surgery
|
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.
|
|
Experimental: TPVB combined ESPB group
Ultrasound-guided thoracic paravertebral nerve block combined with erector spinae muscle block was used for postoperative analgesia after thoracic surgery
|
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.
|
|
Experimental: ICNB group
Intercostal nerve block was used for postoperative analgesia after thoracic surgery
|
Patients undergoing thoracoscopic surgery underwent general anesthesia and patients in ICNB Group received intercostal nerve block for postoperative analgesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
48 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of postoperative complications
Time Frame: 48 hours after surgery
|
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.)
|
48 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Zhuo Liu, The First hosptial of Qinhuangdao
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2024
Primary Completion (Estimated)
November 20, 2024
Study Completion (Estimated)
January 20, 2025
Study Registration Dates
First Submitted
September 12, 2024
First Submitted That Met QC Criteria
September 12, 2024
First Posted (Actual)
September 19, 2024
Study Record Updates
Last Update Posted (Estimated)
December 2, 2024
Last Update Submitted That Met QC Criteria
November 28, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- liuzhuo
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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