Caudal Block With Tramadol and Levobupivacaine or Bupivacaine

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Bupivacaine; Drug: Levobupivacaine

• Registration Number: NCT01974843
• Lead Sponsor: Duzce University

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-10
• Study Completion: 2013-01
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-11-03
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Quality of postoperative analgesia	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 Outcome Measures

Name	Time	Method
Adverse effect	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.

Trial Locations

Locations (1)

Duzce University Medicine School, Anesthesiology and Reanimation Department; 🇹🇷 Duzce, Turkey