Analgesic Efficacy of Lidocaine Plus Bupivacaine Versus Bupivacaine Alone Caudally

Ayancık State Hospital

Status: Completed

Conditions: Anesthesia, Local

Treatments: Drug: 0.5 ml.kg-1 bupivacaine 0.25%; Drug: 0.5 ml.kg-1 bupivacaine 0.25% with the addition of 3 mg/kg lidocaine 1%

Study type: Observational

Funder types: Other

Identifiers

NCT03911648

2019/366

Details and patient eligibility

About

Optimal analgesia following ambulatory surgery is an important matter for patient satisfaction and it reduces unnecessary hospital admissions. This study investigated whether caudal block with different combinations of local anesthetics can alter postoperative pain scores and additional rescue analgesic use. The investigators also aim to determine the side effects of these technique such as nausea, vomiting, bradycardia, hypotension, respiratory depression, length of hospital stay, first micturition or mobilization times, surgical and anesthetic complications.

Full description

Circumcision, which is performed on an outpatient basis is commonly a short durational operation in boys. Postoperative pain and agitation are the most common complaints in children with circumcision. The most important factor affecting the length of hospital stay is to provide an effective analgesia. Various methods are being used to manage postoperative pain such as caudal block, penile block, topical analgesia or intra-venous (iv) analgesics. Caudal block is applicable widely in pediatric day case surgery, providing excellent postoperative analgesia and attenuation of the stress response in children. Opioids can cause several side effects such as respiratory depression, suppression of bowel movements, nausea, vomiting, itching, addiction. Opioid drugs are not recommended in children as well. Lower abdominal surgeries affect dermatomes T10-L1 and blocking these nerve roots provides effective postoperative analgesia. Neuraxial blocks such as epidural and caudal blocks is considered the gold standard regional technique for pain management after lower abdominal surgery, blocking both somatic and visceral pain. Recent studies suggest that lidocaine and bupivacaine can be used in combination or a sole agent when performing regional anesthesia in children. But it remains unknown whether these combinations are useful or simply reflect underlying status. There is no report comparing the effects of bupivacaine alone and in combination with lidocaine at performing caudal epidural block in children. The investigators thus tested the primary hypothesis that combining the two different local anesthetics has a synergistic analgesic effect and can accelerate the onset time and decrease the need for additional analgesic doses. Secondarily, the investigators tested the hypothesis that providing intra-operative and postoperative analgesia reduces the risk of hemodynamic deteriorations, length of hospital stay, first micturition and mobilization times, surgical and anesthetic complications.

Enrollment: 86 patients

Sex: Male

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) class 1.
• Patient underwent elective circumcision operation under general anesthesia and caudal analgesia.

Exclusion criteria

• Procedures simultaneously underwent another operation unrelated to circumcision.
• Patients who had unsuccessful caudal block.

Trial design

86 participants in 2 patient groups

Group B;

Description:

Patients had 0.5 ml.kg-1 bupivacaine 0.25% caudally, the maximum given volume was 20 ml. N=42

Treatment:

Drug: 0.5 ml.kg-1 bupivacaine 0.25%

Group L;

Description:

Patients had 0.5 ml.kg-1 bupivacaine 0.25% with the addition of 3 mg/kg lidocaine 1% caudally, the maximum given volume was 20 ml. N=44

Treatment:

Drug: 0.5 ml.kg-1 bupivacaine 0.25% with the addition of 3 mg/kg lidocaine 1%