The Assessment of Bupivacaine-tramadol and Levobupivacaine-tramadol Combinations for Preemptive Caudal Anaesthesia in Children: a Randomized, Double-blind, Prospective Study
Overview
- Phase
- Not Applicable
- Intervention
- Bupivacaine
- Conditions
- Pain, Postoperative
- Sponsor
- Duzce University
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Quality of postoperative analgesia
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
gulbin sezen
assistant of professor
Duzce University
Eligibility Criteria
Inclusion Criteria
- •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.
Arms & Interventions
Group BT
Bupivacaine-tramadol (BT) group received a caudal injection of bupivacaine 0.25% plus tramadol 2 mg/kg
Intervention: Bupivacaine
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.
Intervention: Levobupivacaine
Outcomes
Primary Outcomes
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
- Adverse effect(Postoperatively at 2, 4, 6, 12, and 24 h)