Comparison of Transversus Abdominis Plane Block and Ilioinguinal / Iliohypogastric Nerve Block

• ClinicalTrials.gov Identifier: NCT02991053
• Recruitment Status: Unknown
• First Posted: December 13, 2016
• Last Update Posted: December 13, 2016
• Sponsor: Erzincan University
• Information provided by (Responsible Party): ILKE KUPELI, Erzincan University

Tracking Information

• First Submitted Date: December 4, 2016
• First Posted Date: December 13, 2016
• Last Update Posted Date: December 13, 2016
• Study Start Date: December 2016
• Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 8, 2016): Amount of anesthetic drug which was used [ Time Frame: 2 hour ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: December 8, 2016): Postoperative visual analogue scale [ Time Frame: one day ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Transversus Abdominis Plane Block and Ilioinguinal / Iliohypogastric Nerve Block
• Official Title: Ultrasonography Guided Ilioinguinal /Iliohypogastric Block Versus Transversus Abdominis Plane Block in Intraoperative Anesthesia in Children - Randomized Controlled Study
• Brief Summary: the aim of this study is to compare the effects of Transversus abdominis plane block and ilioinguinal / iliohypogastric block combined with sedation in pediatric surgeon on the anesthesia and analgesia contributions during surgery without general anesthesia.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care
• Condition: Intra-operative Anesthesia
• Intervention: Drug: ketamine

Study Arms

• Active Comparator: block and ketamine
  Transversus Abdominis Plane block after ketamine atropine induction and continued with ketamine only in anesthesia
  Intervention: Drug: ketamine
• Active Comparator: block; ketamine with laryngeal mask; inhalation anesthesia
  After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane minimum alveolar concentration and oxygen / air mixture and applied Transversus Abdominis Plane block.
  Intervention: Drug: ketamine
• Active Comparator: block and ketamine ıh/ıl
  Ilioinguinal / iliohypogastric block after ketamine atropine induction and continued with ketamine only in anesthesia
  Intervention: Drug: ketamine
• Active Comparator: ıh/ıl block; ketamine; inhalation anesthesia
  After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane minimum alveolar concentration and oxygen / air mixture and applied Ilioinguinal / iliohypogastric block.
  Intervention: Drug: ketamine
• Active Comparator: control group
  After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane minimum alveolar concentration and oxygen / air mixture and Non-block, postoperative analgesia with paracetamol IV
  Intervention: Drug: ketamine

Publications *

• Newman K, Ponsky T, Kittle K, Dyk L, Throop C, Gieseker K, Sills M, Gilbert J. Appendicitis 2000: variability in practice, outcomes, and resource utilization at thirty pediatric hospitals. J Pediatr Surg. 2003 Mar;38(3):372-9; discussion 372-9. doi: 10.1053/jpsu.2003.50111.
• Scott AD, Phillips A, White JB, Stow PJ. Analgesia following inguinal herniotomy or orchidopexy in children: a comparison of caudal and regional blockade. J R Coll Surg Edinb. 1989 Jun;34(3):143-5.
• Markham SJ, Tomlinson J, Hain WR. Ilioinguinal nerve block in children. A comparison with caudal block for intra and postoperative analgesia. Anaesthesia. 1986 Nov;41(11):1098-103. doi: 10.1111/j.1365-2044.1986.tb12956.x.
• Tanaka M, Mori N, Murakami W, Tanaka N, Oku K, Hiramatsu R, Nakagawa M, Yasumoto K. [The effect of transversus abdominis plane block for pediatric patients receiving bone graft to the alveolar cleft]. Masui. 2010 Sep;59(9):1185-9. Japanese.
• Stuart-Smith K. Hemiarthroplasty performed under transversus abdominis plane block in a patient with severe cardiorespiratory disease. Anaesthesia. 2013 Apr;68(4):417-20. doi: 10.1111/anae.12108. Epub 2012 Dec 17.
• Tekelioglu UY, Demirhan A, Sit M, Kurt AD, Bilgi M, Kocoglu H. Colostomy with Transversus Abdominis Plane Block. Turk J Anaesthesiol Reanim. 2015 Dec;43(6):424-6. doi: 10.5152/TJAR.2015.89410. Epub 2015 Dec 1.
• Polaner DM, Taenzer AH, Walker BJ, Bosenberg A, Krane EJ, Suresh S, Wolf C, Martin LD. Pediatric Regional Anesthesia Network (PRAN): a multi-institutional study of the use and incidence of complications of pediatric regional anesthesia. Anesth Analg. 2012 Dec;115(6):1353-64. doi: 10.1213/ANE.0b013e31825d9f4b. Epub 2012 Jun 13.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 8, 2016): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2017
• Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• American society of anesthesia score I-II
• To undergo elective lower abdominal surgery
• between 2-6 years old

Exclusion Criteria:

• Patients with psychiatric disease
• Patients whose weight is more than 40 kg
• Patients with cardiac-pulmonary-neurological disease
• Patients with bleeding disorder
• Patients with infection or scar on the injection area
• Patients with known allergies to local anesthetics

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 6 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02991053
• Other Study ID Numbers: ERZINCAN UNIVERSITY 8
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: ILKE KUPELI, Erzincan University
• Original Responsible Party: Same as current
• Current Study Sponsor: Erzincan University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: ilke kupeli; Erzincan University

• PRS Account: Erzincan University
• Verification Date: December 2016