Back to resultsESPB Versus INB With PCIA in Video-assisted Thoracic Surgery
Primary Purpose
Lung Diseases
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intercostal Nerve Block with PCIA
Erector Spinae Plane Block (ESPB)
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases focused on measuring Erector spinae plane block, Video-assisted thoracic surgery;, Intercostal nerve block, Patient-controlled intravenous analgesia
Eligibility Criteria
Inclusion Criteria:
- Patients to receive video assisted thoracoscopic lobectomy or bullectomy .
Exclusion Criteria:
- 1. Patient refusal 2. Heavy skin eruption and infection at site of injection. 3. Coagulopathy. 4. Allergy to local anesthetics. 5. Taking analgesics.
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Intercostal Nerve Block with PCIA
Erector Spinae Plane Block (ESPB)
Arm Description
Intercostal Nerve Block with patient-controlled intravenous analgesia
Continuous Erector Spinae Plane Block
Outcomes
Primary Outcome Measures
Pain score (NRS)
Numeric Rating Scale is an 11-point scale used by doctors to evaluate patients' pain, where 0 is no pain and 10 the worst imaginable pain. For postoperative patients, an higher score shows inadequate analgesia and worse outcome.
Secondary Outcome Measures
Pain score (NRS)
Numeric Rating Scale is an 11-point scale used by doctors to evaluate patients' pain, where 0 is no pain and 10 the worst imaginable pain. For postoperative patients, an higher score shows inadequate analgesia and worse outcome.
Analgesics consumption
Analgesics include opioids and nonsteroidal anti-inflammatory drugs
Incidence of side effects and complication during study
Side effects and complication
Full Information
NCT ID
NCT03682354
First Posted
August 26, 2018
Last Updated
March 26, 2019
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03682354
Brief Title
ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery
Official Title
Erector Spinae Plane Block Versus Intercostal Nerve Block Combined With Patient-controlled Intravenous Analgesia in Video-assisted Thoracic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 27, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized prospective trial to test the non-inferiority of erector spinae plane block (ESPB) in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in Thoracoscopic lung surgery
Detailed Description
For patients undergoing thoracic surgery, postoperative pain greatly limited their recovery.Multimodal analgesia have shown good efficacy but without reaching full pain relief.
The primary goal of this study is to observe the effect of ultrasound-guided erector spinae plane block in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in video assisted thoracic lung surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
Erector spinae plane block, Video-assisted thoracic surgery;, Intercostal nerve block, Patient-controlled intravenous analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intercostal Nerve Block with PCIA
Arm Type
Active Comparator
Arm Description
Intercostal Nerve Block with patient-controlled intravenous analgesia
Arm Title
Erector Spinae Plane Block (ESPB)
Arm Type
Experimental
Arm Description
Continuous Erector Spinae Plane Block
Intervention Type
Drug
Intervention Name(s)
Intercostal Nerve Block with PCIA
Intervention Description
Intercostal nerve block consists in the injection of Ropivacaine (4 ml,0.5%) in related intercostal spaces. Patient-controlled intravenous analgesia regimen is conducted with sufentanil.
Intervention Type
Drug
Intervention Name(s)
Erector Spinae Plane Block (ESPB)
Intervention Description
Erector Spinae Plane Block consists in the injection of Ropivacaine (20ml, 0.5%), in the anatomical plane between the Erector Spinae muscles and transverse process, laterally to the spinous process of T5 . The catheter was inserted and secured in place under ecographic guidance, and a patient-controlled regional anesthesia regimen was conducted with 0.2% ropivacaine.
Primary Outcome Measure Information:
Title
Pain score (NRS)
Description
Numeric Rating Scale is an 11-point scale used by doctors to evaluate patients' pain, where 0 is no pain and 10 the worst imaginable pain. For postoperative patients, an higher score shows inadequate analgesia and worse outcome.
Time Frame
4 hours from the end of procedure
Secondary Outcome Measure Information:
Title
Pain score (NRS)
Description
Numeric Rating Scale is an 11-point scale used by doctors to evaluate patients' pain, where 0 is no pain and 10 the worst imaginable pain. For postoperative patients, an higher score shows inadequate analgesia and worse outcome.
Time Frame
8, 24,48 hours from the end of procedure
Title
Analgesics consumption
Description
Analgesics include opioids and nonsteroidal anti-inflammatory drugs
Time Frame
During operation,4, 8, 24,48 hours from the end of procedure
Title
Incidence of side effects and complication during study
Description
Side effects and complication
Time Frame
During operation,4, 8, 24,48 hours from the end of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients to receive video assisted thoracoscopic lobectomy or bullectomy .
Exclusion Criteria:
1. Patient refusal 2. Heavy skin eruption and infection at site of injection. 3. Coagulopathy. 4. Allergy to local anesthetics. 5. Taking analgesics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Li
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery
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