NCT01974843

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

1.8 years

First QC Date

October 23, 2013

Last Update Submit

February 6, 2014

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Adverse effect

    Postoperatively at 2, 4, 6, 12, and 24 h

Other Outcomes (1)

  • first analgesic requirement

    Postoperatively 24 h

Study Arms (2)

Group BT

Bupivacaine-tramadol (BT) group received a caudal injection of bupivacaine 0.25% plus tramadol 2 mg/kg

Drug: Bupivacaine

Group LT

Levobupivacaine-tramadol (LT) group received a caudal injection of levobupivacaine 0.25% plus tramadol 2 mg/kg, resulting in a total volume of 1 ml/kg.

Drug: Levobupivacaine

Interventions

LevobupivacaineDRUG

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

Also known as: Chirocaine, Abbott Lab, Nycomed Pharma, Norway
Group LT
BupivacaineDRUG

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)

Also known as: Marcaine, Astra Zeneca, UK
Group BT

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

ASA status I children aged 2 to 7 years who were scheduled for elective inguinal herniorrhaphy or orchidopexy were enrolled.

You may qualify if:

  • ASA I,
  • to 7 years old children
  • Elective inguinal herniorrhaphy or orchidopexy operation

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duzce University Medicine School, Anesthesiology and Reanimation Department

Düzce, 81620, Turkey (Türkiye)

Location

Related Publications (3)

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

    PMID: 16682915BACKGROUND

  • 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. doi: 10.1093/bja/aei059. Epub 2004 Dec 17.

    PMID: 15608043BACKGROUND

  • 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.

    PMID: 20412459BACKGROUND

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

LevobupivacaineBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant of professor

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 4, 2013

Study Start

January 1, 2011

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations

TU(1)