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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01974843
Enrollment
68
Registered
2013-11-04
Start date
2011-01-31
Completion date
2013-01-31
Last updated
2014-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

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.

Interventions

DRUGLevobupivacaine

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

DRUGBupivacaine

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)

Sponsors

Duzce University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of postoperative analgesiaPostopertively 24 hThe 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

MeasureTime frameDescription
Adverse effectPostoperatively at 2, 4, 6, 12, and 24 hAll patients were observed in the hospital for at least 24 h because of the possible side effects of caudal blocks.

Other

MeasureTime frameDescription
first analgesic requirementPostoperatively 24 hIn 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026