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PainNCT01740193

Comparison of Two Different Pain Management Techniques in Pediatric Patients Undergoing a Hernia Repair

A study testing TAP Block and Ilioinguinal/iliohypogastric blockade in people with Pain and Inguinal Hernia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to find the best way to decrease pain in children right after surgery whom have had their hernia fixed. Right now, there are two different ways surgeons and anesthesia providers try to decrease pain. It is not clear if one way is better than the other. Read more about this study

Who is it for?
Ages 12 months to 10 years
Conditions the study is for
Pain, Inguinal Hernia
What is being tested?
TAP Block and Ilioinguinal/iliohypogastric blockade
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteUnited States
Study dates
Aug 2012to Dec 2017
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 12 months to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • The subject is male or female;
  • The subject is of any racial and ethnic groups;
  • The subject is age 12 months to 10 years (inclusive);
  • The subject weighs more than 8.0 kg (inclusive of the eighth kilogram);
  • The subject is scheduled for the following: Unilateral herniorrhaphy scheduled on an out-patient basis, and not being performed in conjunction with any other surgical procedures;
  • The subject is American Society of Anesthesiologists (ASA) patient classification I-II
  • The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.

Who cannot join

  • Additional surgical procedures are being performed concurrently;
  • The subject is ASA classification > II;
  • The subject has pre-existing allergies to local anesthetics;
  • The subject receives midazolam as a premedication;
  • The subject has an imminent life threatening condition that impacts the ability to obtain informed consent;
  • The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cincinnati Children's Hosptial Medical Center - Liberty Campus

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Randomized Prospective Comparison of Analgesic Efficacy of Surgeon Performed IIlioinguinal/Iliohypogastric Blockade With Ultrasound-Guided TAP Blockade in Pediatric Patients Undergoing Unilateral Herniorrhaphy on an Outpatient Basis

The purpose of this research study is to find the best way to decrease pain in children right after surgery whom have had their hernia fixed. Right now, there are two different ways surgeons and anesthesia providers try to decrease pain. It is not clear if one way is better than the other. The method used is often chosen by which one the doctor has more experience using. The Investigator plans to find out if one of the methods is more effective and/or safer than the other method.

The results of this study will help learn how to best control pain in children having surgery for hernia repair.

Read the detailed description

Unilateral inguinal herniorrhaphy is a commonly performed surgical procedure in the pediatric population. Multimodal anesthesia consisting of systemic narcotics, surgical wound infiltration with local anesthetic and ilioinguinal and/or iliohypogastric nerve blockade has traditionally been employed to achieve acceptable analgesia. Recently, ultrasound-based studies have demonstrated that blind abdominal wall injections are done with poor accuracy. Ultrasound-guided alternatives, such as the transverses abdominis plane (TAP) block, may improve analgesic efficacy and patient comfort in the post-operative period when compared to blind landmark based nerve blockade. There has been increasing utilization of the TAP block in the adult population due to the described ability to provide effective blockade of the thoracolumbar spinal nerves innervating the abdominal wall. We propose a randomized prospective evaluation of the analgesic efficacy comparing surgeon performed ilioinguinal/iliohypogastric block with ultrasound-guided TAP blockade in healthy ASA I and II pediatric patients undergoing unilateral herniorrhaphy on an outpatient basis.

Being tested
TAP Block, Ilioinguinal/iliohypogastric blockade
Keywords
Pain, Regional Anesthesia, ultrasound, transversus abdominis plane, herniorrhaphy, pediatrics
Medical subject headings
Pain, Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAP BlockProcedure or surgery

    Also called transversus abdominis plane block

    While the terminal branches of T7 to L1 cannot be visualized under ultrasound as they pass between the internal oblique and the transverse abdominis muscles, they are expected to lie within this plane. The three muscular layers of the abdominal wall, however, can be easily identified under ultrasound guidance. A needle is advanced under ultrasound guidance towards the fascial plane that separates the internal oblique and the transversus abdominis muscles, at which point local anesthetic is deposited under direct visualization.

  • Ilioinguinal/iliohypogastric blockadeProcedure or surgery

    Ilioinguinal and iliohypogastric blockade is performed as an injection after palpation of the anterior superior iliac spine followed be a perceived loss of resistance with insertion of the needle, or may be infiltrated locally following herniorrhaphy exposure as anatomic landmarks can prove to be difficult to locate in the anesthetized pediatric patient.

Study groups in NCT01740193
Study groupRoleWhat they receive
TAP BlockActive comparatorNot described
Receives: Procedure: TAP Block
Ilioinguinal/iliohypogastric blockadeActive comparatorNot described
Receives: Procedure: Ilioinguinal/iliohypogastric blockade

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy Outcome

    Worst FLACC score observed in the post-anesthesia care unit by the research coordinator during the first post-operative hour

    Measured: Participants will be followed for the duration of post-anesthesia care unit stay, an expected average of 2 hours

Secondary outcomes (6)

  1. Efficacy Outcome - Length of Recovery Room

    time required for the patient to meet discharge criteria

    Measured: participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours

  2. Confounding Variable - Electrocautery

    whether or not cautery was used as a measure of surgical technique

    Measured: participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours

  3. Confounding Variable - Surgical dissection

    length of surgical procedure as an indicator of the extent of surgical dissection performed

    Measured: participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours

  4. Confounding Variable - Length of time for TAP

    length of time required to perform TAP block

    Measured: participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours

  5. Efficacy Outcome - Post-operative Calls

    Phone calls made to surgeons regarding parental concern of post-operative pain forty-eight hours post-operatively

    Measured: participants will be followed for 48 hours after procedure

  6. Outcome Measure - Number of patients with post-operative complications

    presence of post-operative complications

    Measured: participants will be followed for 48 hours after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJun 2017
  4. Study completionDec 2017

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01740193
Sponsor's protocol ID
2011-1778
Status last verified
Dec 2018
First submitted
30 Nov 2012
Last updated
19 Dec 2018
Results posted
No
Data monitoring committee
No

Publications

  • Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.

    PubMed 19561014

  • Fredrickson M, Seal P, Houghton J. Early experience with the transversus abdominis plane block in children. Paediatr Anaesth. 2008 Sep;18(9):891-2. doi: 10.1111/j.1460-9592.2008.02591.x. No abstract available.

    PubMed 18768050

  • Aveline C, Le Hetet H, Le Roux A, Vautier P, Cognet F, Vinet E, Tison C, Bonnet F. Comparison between ultrasound-guided transversus abdominis plane and conventional ilioinguinal/iliohypogastric nerve blocks for day-case open inguinal hernia repair. Br J Anaesth. 2011 Mar;106(3):380-6. doi: 10.1093/bja/aeq363. Epub 2010 Dec 21.

    PubMed 21177284

  • Fredrickson MJ, Seal P. Ultrasound-guided transversus abdominis plane block for neonatal abdominal surgery. Anaesth Intensive Care. 2009 May;37(3):469-72. doi: 10.1177/0310057X0903700303.

    PubMed 19499870

  • Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.

    PubMed 9459225

  • Hadzic A, New York School of Regional Anesthesia.: Textbook of regional anesthesia and acute pain management. New York: McGraw-Hill, Medical Pub. Division; 2007.

Questions about this trial

What is this clinical trial studying?

A study testing TAP Block and Ilioinguinal/iliohypogastric blockade in people with Pain and Inguinal Hernia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

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 7 inclusion and 6 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 19 Dec 2018. 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 United States. 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?

Efficacy Outcome (time frame: Participants will be followed for the duration of post-anesthesia care unit stay, an expected average of 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01740193, which also lists 6 linked publications.

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 19 Dec 2018.

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