Caudal Block With Tramadol and Levobupivacaine or Bupivacaine
Information source: Duzce University
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Levobupivacaine (Drug); Bupivacaine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Duzce University
Summary
Caudal block is the regional anesthetic technique that is used most frequently in pediatric
surgery. Opioid drugs have been added to local anesthetic solutions to prolong duration of
analgesia but ideal combination were not found that has minimal adverse effect. The aim of
this study was to compare the postoperative analgesic efficacy of equal concentrations of
bupivacaine plus tramadol or levobupivacaine plus tramadol in pediatric patients undergoing
minor urological surgery.
Clinical Details
Official title: The Assessment of Bupivacaine-tramadol and Levobupivacaine-tramadol Combinations for Preemptive Caudal Anaesthesia in Children: a Randomized, Double-blind, Prospective Study
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Quality of postoperative analgesia
Secondary outcome: Adverse effect
Detailed description:
Sixty-eight children aged 2 to 7 years who were undergoing inguinal herniorrhaphy or
orchidopexy received bupivacaine 0. 25% plus tramadol 2 mg/kg (BT group) or levobupivacaine
0. 25% plus tramadol 2 mg/kg (LT group) by the caudal route after laryngeal mask anesthesia.
The primary outcome of the study was to compare the duration and quality of postoperative
analgesia. The postoperative pain relief was evaluated by the Children and Infants
Postoperative Pain Scale (CHIPPS) at 2, 4, 6, 12, and 24 h postoperatively. In addition, the
time of first analgesic requirement was noted.
Eligibility
Minimum age: 2 Years.
Maximum age: 7 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- ASA I,
- 2 to 7 years old children
- Elective inguinal herniorrhaphy or orchidopexy operation
Exclusion Criteria:
- Infection at the site of block, bleeding diathesis, pre-existing neurological or
spinal disease, or abnormalities of the sacrum) or with a known allergy to local
anesthetics were excluded.
Locations and Contacts
Duzce University Medicine School, Anesthesiology and Reanimation Department, Duzce 81620, Turkey
Additional Information
caudal block usage in pediatric patients performing of caudal block in pediatric patients
Related publications: Silvani P, Camporesi A, Agostino MR, Salvo I. Caudal anesthesia in pediatrics: an update. Minerva Anestesiol. 2006 Jun;72(6):453-9. Review. Locatelli B, Ingelmo P, Sonzogni V, Zanella A, Gatti V, Spotti A, Di Marco S, Fumagalli R. Randomized, double-blind, phase III, controlled trial comparing levobupivacaine 0.25%, ropivacaine 0.25% and bupivacaine 0.25% by the caudal route in children. Br J Anaesth. 2005 Mar;94(3):366-71. Epub 2004 Dec 17. Yildiz TS, Ozdamar D, Bagus F, Solak M, Toker K. Levobupivacaine-tramadol combination for caudal block in children: a randomized, double-blinded, prospective study. Paediatr Anaesth. 2010 Jun;20(6):524-9. doi: 10.1111/j.1460-9592.2010.03296.x. Epub 2010 Apr 14.
Starting date: January 2011
Last updated: February 6, 2014
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