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Completed

NCT Number: NCT01974843

Caudal Block With Tramadol and Levobupivacaine or Bupivacaine

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duzce University Medicine School, Anesthesiology and Reanimation Department

Düzce, 81620, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivacaine

Drug

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

Bupivacaine

Drug

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

Primary outcomes

  1. Quality of postoperative analgesia

    Time frame: Postopertively 24 h

    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.

Secondary outcomes

  1. Adverse effect

    Time frame: Postoperatively at 2, 4, 6, 12, and 24 h

    All patients were observed in the hospital for at least 24 h because of the possible side effects of caudal blocks.

Other outcomes

  1. first analgesic requirement

    Time frame: Postoperatively 24 h

    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.

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 4, 2013
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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