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Caudal Block With Tramadol and Levobupivacaine or Bupivacaine

Information source: Duzce University
ClinicalTrials.gov processed this data on August 23, 2015
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


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.


Minimum age: 2 Years. Maximum age: 7 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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