Postoperative Pain Clinical Trial
Official title:
The Effect of the Transversalis Fascia Plane Block on Postoperative Pain Behavior After Hernia Repair Surgery in Children - Comparison With Conventional Ilioinguinal/Iliohypogastric Nerve Block-
NCT number | NCT03520907 |
Other study ID # | TFPBvsIIB |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 26, 2018 |
Est. completion date | June 27, 2019 |
Verified date | August 2019 |
Source | Ibaraki Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study compares the transversalis fascia plane block with the
ilioinguinal/iliohypogastric nerve block in children undergoing hernia repair surgery.
Half of participants will receive the transversalis fascia plane block, while the other will
receive the ilioinguinal/iliohypogastric nerve block.
Status | Completed |
Enrollment | 80 |
Est. completion date | June 27, 2019 |
Est. primary completion date | June 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 13 Years |
Eligibility |
Inclusion Criteria: - the patients undergoing unilateral open hernia repair surgery Exclusion Criteria: - known allergy to local anesthetics, psychomotor retardation, anti-epileptic drugs usage, anti-inflammatory drug usage |
Country | Name | City | State |
---|---|---|---|
Japan | Ibaraki Children's Hospital | Mito | Ibaraki |
Lead Sponsor | Collaborator |
---|---|
Kazuhiko Okuyama, MD |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | intraoperative heart rate changes | heart rate during surgery | just before surgery start, one minute after incision, maximum value during surgery | |
Other | intraoperative respiratory rate changes | respiratory rate during surgery | just before surgery start, one minute after incision, maximum value during surgery | |
Primary | walking appearance | scoring a way of walking; 0: brisk walk, big step, able to skip (= no pain) to 5: not able to stand up ( = worst pain) | 3 to 5 hours after surgery | |
Secondary | FLACC (face, legs, activity, cry, consolability) score | behavioral pain scale in children. Each category has 0 to 2 score; Total 0 (no pain) to 10 (worst) | 3 to 5 hours after surgery | |
Secondary | Faces Pain Scale revised | self-reported pain score. Children choose a face from six faces. | 3 to 5 hours after surgery | |
Secondary | additional pain curer usage | request or necessity of administration of acetaminophen or flurbiprofen | up to 5 hours after surgery |
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