Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery

Overview

The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Supportive Care
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: November 2015

Detailed Description

It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity, cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable. Postoperative hemodynamics parameters will be recordes at 24 h.

Interventions

• Drug: Clonidine 1 mcg/Kg
  • Clonidine 1 mcg/Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
• Drug: Clonidine 2 mcg/ Kg
  • Clonidine 2 mcg//Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
• Drug: Clonidine 3 mcg/ Kg
  • Clonidine 3 mcg //Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery

Arms, Groups and Cohorts

• No Intervention: Bupivacaine 0,166%
  • General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% for hypospadia surgery
• Active Comparator: Clonidine 1 mcg/Kg
  • IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 1 mcg/ Kg of clonidine for hypospadia surgery
• Active Comparator: Clonidine 2 mcg/ Kg
  • IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 2 mcg/ Kg of clonidine for hypospadia surgery
• Active Comparator: Clonidine 3 mcg/Kg
  • General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 3 mcg/ Kg of clonidine for hypospadia surgery

Clinical Trial Outcome Measures

Primary Measures

• Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption
  • Time Frame: 24 hours after the surgery

Participating in This Clinical Trial

Inclusion Criteria

• CHildren 1 – 10 years old. – ASA I E II ( American Society of Anesthesiology) – hypospadias surgery Exclusion Criteria:

• parents refuse – Infection – Coagulation disorders – Allergy to anesthetics – Abnormalities of the sacral spine

Gender Eligibility: Male

Minimum Age: 1 Year

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Federal University of Minas Gerais
• Provider of Information About this Clinical Study
  • Principal Investigator: Renato Santiago Gomez, PhD – Federal University of Minas Gerais
• Overall Official(s)
  • ana claudia mota bonisson, M, Principal Investigator, Hospital da Baleia – Fundação Benjamim Guimaraes

References

Fernandes ML, Pires KC, Tiburcio MA, Gomez RS. Caudal bupivacaine supplemented with morphine or clonidine, or supplemented with morphine plus clonidine in children undergoing infra-umbilical urological and genital procedures: a prospective, randomized and double-blind study. J Anesth. 2012 Apr;26(2):213-8. doi: 10.1007/s00540-011-1297-y. Epub 2011 Dec 10.

Mauch J, Weiss M. [Pediatric caudal anesthesia: importance and aspects of safety concerns]. Schmerz. 2012 Aug;26(4):443-53; quiz 454. doi: 10.1007/s00482-012-1202-0. German.