Back to resultsESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure
Primary Purpose
Nerve Block, Analgesia, Pectus Excavatum
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ESPB group
TPVB group
Sponsored by
About this trial
This is an interventional supportive care trial for Nerve Block
Eligibility Criteria
Inclusion Criteria:
- Age between 4 to 18 years Scheduled for elective Nuss surgery Written informed consent is obtained from parents of each patient.
Exclusion Criteria:
- Coagulation dysfunction. American Society of Anesthesiologists Physical Status 4 or 5. Allergy to study medication. Local infection at the site of injection or systemic infection. Inability to understand Chinese.
Sites / Locations
- Department of Anesthesiology, West China HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ESPB group
TPVB group
Arm Description
0.25% ropivacaine 0.5 ml/kg is injected at the fascial plane deep to the erector spinae muscle
0.25% ropivacaine 0.5 ml/kg is injected into the thoracic paravertebral space (T5) using TPVB approach.
Outcomes
Primary Outcome Measures
Pain scores at rest at 24 hours postoperatively
Pain scores will be recorded using the Numeric Rating Scale (NRS) scores (0-10).
Secondary Outcome Measures
The pain degree at rest and after movement or coughing(dynamic)
The pain degree at rest and after movement or coughing at 3, 6, 12, 24, and 48 hours after surgery respectively.
total rescue morphine-equivalent consumption per weight
total rescue morphine-equivalent consumption per weight at predetermined time intervals (24 and 48 hours) after surgery
Emergence agitation at 5, 15, 30 min after extubation
Emergence agitation will be registered using pediatric anesthesia emergence delirium (PAED) at 5, 15, 30 min after extubation
Total dosage of intraoperative sufentanil and remifentanil
Total dosage of intraoperative sufentanil and remifentanil per weight
The time to first analgesia request
Time from operation to first rescue analgesia request
The time to first mobilization
Time from operation to ambulation
Side effects
Side effects such as pneumothorax, local anesthetic toxicity, postoperative nausea and vomiting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05034601
Brief Title
ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure
Official Title
Comparison of Erector Spinae Plane and Paravertebral Nerve Blocks for Postoperative Analgesia in Children After the Nuss Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 25, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a prospective randomized double-blind non-inferiority trial designed to test the hypothesis that erector spinae plane block (ESPB) is non-inferior to thoracic paravertebral block (TPVB) in postoperative pain control after pectus excavatum repair.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Block, Analgesia, Pectus Excavatum
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESPB group
Arm Type
Experimental
Arm Description
0.25% ropivacaine 0.5 ml/kg is injected at the fascial plane deep to the erector spinae muscle
Arm Title
TPVB group
Arm Type
Active Comparator
Arm Description
0.25% ropivacaine 0.5 ml/kg is injected into the thoracic paravertebral space (T5) using TPVB approach.
Intervention Type
Procedure
Intervention Name(s)
ESPB group
Other Intervention Name(s)
Erector spinae plane block
Intervention Description
A 21-gauge 100-mm needle will be inserted into the fascial layer beneath the iliocostalis, longissimus, and spinalis muscles. A bolus of 0.25% ropivacaine 0.5 ml/kg will be injected into the fascial layer. Contralateral ESPB will be performed similarly.
Intervention Type
Procedure
Intervention Name(s)
TPVB group
Other Intervention Name(s)
Thoracic paravertebral block
Intervention Description
A 21-gauge 100-mm insulated needle will be inserted into the paravertebral space via an in-plane parasagittal approach. After perforating the costotransverse ligament, 0.25% ropivacaine 0.5 ml/kg will be injected. Anterior movement of the pleura indicated the appropriate spread of the local anesthetics in the paravertebral space. The process will be repeated on the contralateral side.
Primary Outcome Measure Information:
Title
Pain scores at rest at 24 hours postoperatively
Description
Pain scores will be recorded using the Numeric Rating Scale (NRS) scores (0-10).
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
The pain degree at rest and after movement or coughing(dynamic)
Description
The pain degree at rest and after movement or coughing at 3, 6, 12, 24, and 48 hours after surgery respectively.
Time Frame
at 3, 6, 12, 24, and 48 hours after surgery
Title
total rescue morphine-equivalent consumption per weight
Description
total rescue morphine-equivalent consumption per weight at predetermined time intervals (24 and 48 hours) after surgery
Time Frame
at 24 and 48 hours after surgery
Title
Emergence agitation at 5, 15, 30 min after extubation
Description
Emergence agitation will be registered using pediatric anesthesia emergence delirium (PAED) at 5, 15, 30 min after extubation
Time Frame
at 5, 15, 30 min after extubation
Title
Total dosage of intraoperative sufentanil and remifentanil
Description
Total dosage of intraoperative sufentanil and remifentanil per weight
Time Frame
during surgery
Title
The time to first analgesia request
Description
Time from operation to first rescue analgesia request
Time Frame
within the 3 days after surgery
Title
The time to first mobilization
Description
Time from operation to ambulation
Time Frame
within the 3 days after surgery
Title
Side effects
Description
Side effects such as pneumothorax, local anesthetic toxicity, postoperative nausea and vomiting
Time Frame
within the 5 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 4 to 18 years Scheduled for elective Nuss surgery Written informed consent is obtained from parents of each patient.
Exclusion Criteria:
Coagulation dysfunction. American Society of Anesthesiologists Physical Status 4 or 5. Allergy to study medication. Local infection at the site of injection or systemic infection. Inability to understand Chinese.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Yang, MD
Phone
+86- 18980602269
Email
yangjing@wchscu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Liu
Organizational Affiliation
Department of Anesthesiology, West China Hospital, Sichuan University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesiology, West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Yang, MD
Phone
+86- 18980602269
Email
yangjing@wchscu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35164831
Citation
Xu M, Zhang G, Gong J, Yang J. Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial. Trials. 2022 Feb 14;23(1):139. doi: 10.1186/s13063-022-06044-y.
Results Reference
derived
Learn more about this trial
ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure
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