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Caudal Block With Tramadol and Levobupivacaine or Bupivacaine

D

Duzce University

Status

Completed

Conditions

Pain, Postoperative

Treatments

Drug: Levobupivacaine
Drug: Bupivacaine

Study type

Observational

Funder types

Other

Identifiers

NCT01974843
DZC-160

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 patients

Sex

All

Ages

2 to 7 years old

Volunteers

No Healthy Volunteers

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.

Trial design

68 participants in 2 patient groups

Group BT
Description:
Bupivacaine-tramadol (BT) group received a caudal injection of bupivacaine 0.25% plus tramadol 2 mg/kg
Treatment:
Drug: Bupivacaine
Group LT
Description:
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.
Treatment:
Drug: Levobupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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