Postoperative Analgesia With Erector Spinae Plane Block After Pectus Excavatum Repair in Children
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|ClinicalTrials.gov Identifier: NCT04081922|
Recruitment Status : Not yet recruiting
First Posted : September 9, 2019
Last Update Posted : November 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pectus Excavatum||Procedure: Erector spinae plane block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Postoperative Analgesia With Erector Spinae Plane Block After Pectus Excavatum Repair in Children|
|Estimated Study Start Date :||November 30, 2019|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||December 30, 2021|
Experimental: Regional analgesia using erector spinae plane block
After pectus excavatum is done, intravenous patient controlled analgesia device with fentanyl is connected. Then, regional analgesia is performed for additional analgesia; ultrasound guided erector spinae plane block is performed using 0.25% ropivacaine (total 1 ml/kg) bilaterally. Plasma concentration of ropivacaine at baseline, and 5, 10, 20, 30, 60, 120 minutes after ropivacaine injection will be measured.
Procedure: Erector spinae plane block
Using ultrasound, place the needle in the erector spinae fascia plane at T7-8 level. Then, 0.25% ropivacaine 0.5 ml is injected to confirm the needle location. After checking the location, 0.25% ropivacaine 0.5 ml/kg is administered. This procedure is repeated at contralateral side.
No Intervention: Control
After pectus excavatum is done, intravenous patient controlled analgesia device with fentanyl is connected. No regional block is performed.
- Pain score [ Time Frame: 1 hour after surgery ]The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used. FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
- Fentanyl dosage (mcg/kg) [ Time Frame: until hospital discharge (postoperative day 3) ]Total dosage of fentanyl used postoperatively via patient controlled analgesia (mcg/kg)
- Dose of rescue analgesics (mg/kg) [ Time Frame: until hospital discharge (postoperative day 3 ]If additional analgesics are required due to uncontrolled pain, intravnous acetaminophen and ketocin can be administered.
- Plasma concentration of ropivacaine [ Time Frame: 5, 10, 20, 30, 60, 120 minutes after injection ]Plasma concentration of ropivacaine after injection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04081922
|Contact: Jin-Tae Kim, MD, PhDemail@example.com|
|Korea, Republic of|
|Seoul national university hospital|
|Seoul, Korea, Republic of, 03080|
|Principal Investigator:||Jin-Tae Kim, MD, PhD||Seoul National University Hospital|