An interventional study of Transversalis Fascia Plane Block and Ilioinguinal/iliohypogastric Nerve Block in Postoperative Pain, Inguinal Hernia Unilateral and Children, Only, sponsored by Kazuhiko Okuyama, MD. Completed at 1 site in Japan. Open to participants aged 2 Years to 13 Years. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by Kazuhiko Okuyama, MD · Not applicable, Interventional, and Treatment
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.
The ilioinguinal/iliohypogastric nerve block (II/IH B)is a widely used regional anesthesia technique in inguinal hernia repair surgery. However, this block provides limited analgesia during and after surgery, and the patients feel pain when walking. The transversalis fascia plane block (TFPB) is a recently developed technique and several case reports presented its efficacy for inguinal repair surgery in adult patients. It may block not only ilioinguinal and iliohypogastric nerves but also splanchnic nerves, which is conveyed via the thoracolumbar fascia. Therefore, we compare the effect of the TFPB and II/IH B on postoperative pain and walking form.
5,095 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 80 is close to the median of 75 across 4,346 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with Kazuhiko Okuyama, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
receive transversalis fascia plane block with 0.4 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.
Drug: Transversalis Fascia Plane Block
receive ilioinguinal/iliohypogastric nerve block with 0.1 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.
Drug: Ilioinguinal/iliohypogastric Nerve Block
block will be performed under real-time ultrasound guidance
Also known as: TFPB
block will be performed under real-time ultrasound guidance
Also known as: II/IH B
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)
Time frame: 3 to 5 hours after surgery
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)
Time frame: 3 to 5 hours after surgery
Faces Pain Scale revised
self-reported pain score. Children choose a face from six faces.
Time frame: 3 to 5 hours after surgery
additional pain curer usage
request or necessity of administration of acetaminophen or flurbiprofen
Time frame: up to 5 hours after surgery
intraoperative heart rate changes
heart rate during surgery
Time frame: just before surgery start, one minute after incision, maximum value during surgery
intraoperative respiratory rate changes
respiratory rate during surgery
Time frame: just before surgery start, one minute after incision, maximum value during surgery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.