Postoperative PainNCT03520907
The Comparison of the Transversalis Fascia Plane Block With Ilioinguinal/Iliohypogastric Nerve Block
A study testing Transversalis Fascia Plane Block and Ilioinguinal/iliohypogastric Nerve Block in people with Postoperative Pain and Inguinal Hernia Unilateral, run by Kazuhiko Okuyama, MD at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 13 years
- Conditions the study is for
- Postoperative Pain, Inguinal Hernia Unilateral, Children, Only
- What is being tested?
- Transversalis Fascia Plane Block and Ilioinguinal/iliohypogastric Nerve Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- 26 Apr 2018to 27 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- the patients undergoing unilateral open hernia repair surgery
Who cannot join
- known allergy to local anesthetics, psychomotor retardation, anti-epileptic drugs usage, anti-inflammatory drug usage
Trial locations and contacts
1 site in 1 country.
About this study
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-
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.
Read the detailed description
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.
- Being tested
- Transversalis Fascia Plane Block, Ilioinguinal/iliohypogastric Nerve Block
- Keywords
- transversalis fascia, ilioinguinal/iliohypogastric nerve, inguinal hernia repair, children
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversalis Fascia Plane BlockDrug
Also called TFPB
block will be performed under real-time ultrasound guidance
Ilioinguinal/iliohypogastric Nerve BlockDrug
Also called II/IH B
block will be performed under real-time ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Transversalis Fascia Plane Block | Experimental | receive transversalis fascia plane block with 0.4 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia. Receives: Drug: Transversalis Fascia Plane Block |
| Ilioinguinal/iliohypogastric Nerve Block | Active comparator | receive ilioinguinal/iliohypogastric nerve block with 0.1 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia. Receives: Drug: Ilioinguinal/iliohypogastric Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 to 5 hours after surgery
Secondary outcomes (3)
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)
Measured: 3 to 5 hours after surgery
Faces Pain Scale revised
self-reported pain score. Children choose a face from six faces.
Measured: 3 to 5 hours after surgery
additional pain curer usage
request or necessity of administration of acetaminophen or flurbiprofen
Measured: up to 5 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start26 Apr 2018
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazuhiko Okuyama, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kazuhiko Okuyama, MD, Ibaraki Children's Hospital
- Investigators
- Kazuhiko Okuyama, MD, Study director, Ibaraki Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520907
- Sponsor's protocol ID
- TFPBvsIIB
- Status last verified
- Aug 2019
- First submitted
- 18 Apr 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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-
- ClinicalTrials.gov ID
- NCT03520907
- Acronym / sponsor ID
- TFPBvsIIB
- Keywords
- transversalis fascia, ilioinguinal/iliohypogastric nerve, inguinal hernia repair, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kazuhiko Okuyama, MDUniversity, hospital or other
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversalis Fascia Plane Block | Experimental | Drug: Transversalis Fascia Plane Blockreceive transversalis fascia plane block with 0.4 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia. |
| Ilioinguinal/iliohypogastric Nerve Block | Active comparator | Drug: Ilioinguinal/iliohypogastric Nerve Blockreceive ilioinguinal/iliohypogastric nerve block with 0.1 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia. |
Who may qualify
- Ages
- 2 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- the patients undergoing unilateral open hernia repair surgery
Key exclusion criteria (1 listed)
- known allergy to local anesthetics, psychomotor retardation, anti-epileptic drugs usage, anti-inflammatory drug usage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversalis Fascia Plane BlockAlso: TFPBblock will be performed under real-time ultrasound guidance | Drug | Transversalis Fascia Plane Block |
| Ilioinguinal/iliohypogastric Nerve BlockAlso: II/IH Bblock will be performed under real-time ultrasound guidance | Drug | Ilioinguinal/iliohypogastric Nerve Block |
Primary outcome
walking appearance
Time frame: 3 to 5 hours after surgery
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 secondary outcomes
FLACC (face, legs, activity, cry, consolability) score
Time frame: 3 to 5 hours after surgery
Faces Pain Scale revised
Time frame: 3 to 5 hours after surgery
additional pain curer usage
Time frame: up to 5 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuhiko Okuyama, MD study director
Ibaraki Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversalis Fascia Plane Block and Ilioinguinal/iliohypogastric Nerve Block in people with Postoperative Pain and Inguinal Hernia Unilateral, run by Kazuhiko Okuyama, MD at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
walking appearance (time frame: 3 to 5 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.