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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP Block | Active Comparator |
| |
| Ilioinguinal/iliohypogastric blockade | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP Block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Outcome | Worst FLACC score observed in the post-anesthesia care unit by the research coordinator during the first post-operative hour | Participants will be followed for the duration of post-anesthesia care unit stay, an expected average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Outcome - Length of Recovery Room | time required for the patient to meet discharge criteria | participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours |
| Confounding Variable - Electrocautery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie Furstein, CRNA, DNAP | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hosptial Medical Center - Liberty Campus | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19561014 | Background | 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. | |
| 18768050 | Background | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046449 | Hernia, Abdominal |
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| Ilioinguinal/iliohypogastric blockade | Procedure | 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. |
|
whether or not cautery was used as a measure of surgical technique
| participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours |
| Confounding Variable - Surgical dissection | length of surgical procedure as an indicator of the extent of surgical dissection performed | participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours |
| Confounding Variable - Length of time for TAP | length of time required to perform TAP block | participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours |
| Efficacy Outcome - Post-operative Calls | Phone calls made to surgeons regarding parental concern of post-operative pain forty-eight hours post-operatively | participants will be followed for 48 hours after procedure |
| Outcome Measure - Number of patients with post-operative complications | presence of post-operative complications | participants will be followed for 48 hours after procedure |
| 21177284 | Background | 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. |
| 19499870 | Background | 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. |
| 9459225 | Background | 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. |
| Background | Hadzic A, New York School of Regional Anesthesia.: Textbook of regional anesthesia and acute pain management. New York: McGraw-Hill, Medical Pub. Division; 2007. |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |