Caudal Block With Tramadol and Levobupivacaine or Bupivacaine

Pain, Postoperative Clinical Trial

Official title:

The Assessment of Bupivacaine-tramadol and Levobupivacaine-tramadol Combinations for Preemptive Caudal Anaesthesia in Children: a Randomized, Double-blind, Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974843
• Other study ID #: DZC-160
• Status: Completed
• Phase: N/A
• First received: October 23, 2013
• Last updated: February 6, 2014
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2014
• Source: Duzce University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 7 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Levobupivacaine
in the levobupivacaine-tramadol (LT) group received a caudal injection of levobupivacaine 0.25% plus tramadol 2 mg/kg (maximum doses; 35 mg levobupivacaine plus 35 mg tramadol), resulting in a total volume of 1 ml/kg at maximum volume of 15 ml
• Bupivacaine
in the bupivacaine-tramadol (BT) group received a caudal injection of bupivacaine 0.25% plus tramadol 2 mg/kg (maximum doses; 35 mg bupivacaine plus 35 mg tramadol)

Locations

Country	Name	City	State
Turkey	Duzce University Medicine School, Anesthesiology and Reanimation Department	Duzce

Sponsors (1)

Lead Sponsor	Collaborator
Duzce University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

Silvani P, Camporesi A, Agostino MR, Salvo I. Caudal anesthesia in pediatrics: an update. Minerva Anestesiol. 2006 Jun;72(6):453-9. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	first analgesic requirement	In the case of a CHIPPS score of 4 or more, paracetamol 30 mg.kg -1 was administered rectally. The duration of analgesia was defined by noting the time from caudal injection to the time of first analgesic requirement.	Postoperatively 24 h	No
Primary	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.	Postopertively 24 h	No
Secondary	Adverse effect	All patients were observed in the hospital for at least 24 h because of the possible side effects of caudal blocks.	Postoperatively at 2, 4, 6, 12, and 24 h	No

External Links

•   caudal block usage in pediatric patients
•   performing of caudal block in pediatric patients