Caudal Block With Tramadol and Levobupivacaine or Bupivacaine

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Bupivacaine; Drug: Levobupivacaine

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.

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• Turkey
  • Duzce, Turkey, 81620
    • Duzce University Medicine School, Anesthesiology and Reanimation Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group BT; Bupivacaine-tramadol (BT) group received a caudal injection of bupivacaine 0.25% plus tramadol 2 mg/kg	Drug: 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); Other Names: Marcaine, Astra Zeneca, UK
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; 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; Other Names: Chirocaine, Abbott Lab, Nycomed Pharma, Norway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Duzce University

Publications and helpful links

General Publications

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

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 23, 2013
• First Submitted That Met QC Criteria: October 28, 2013
• First Posted (Estimate): November 3, 2013

Study Record Updates

• Last Update Posted (Estimate): February 7, 2014
• Last Update Submitted That Met QC Criteria: February 6, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Levobupivacaine
• Other Study ID Numbers: DZC-160