Analgesic Efficacy of Lidocaine Plus Bupivacaine Versus Bupivacaine Alone Caudally

Anesthesia, Local Clinical Trial

Official title:

The Efficacy of Bupivacaine Alone and in Combination With Lidocaine at Performing Caudal Block on Analgesia in Pediatric Patients Underwent Circumcision: A Historical Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911648
• Other study ID #: 2019/366
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: August 15, 2018

Study information

• Verified date: April 2019
• Source: Ayancik State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: August 15, 2018
• Est. primary completion date: July 15, 2018
• Gender: Male
• Age group: 2 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

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

Locations

Country	Name	City	State
Turkey	Ayancik State Hospital	Sinop

Sponsors (1)

Lead Sponsor	Collaborator
Ayancik State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who require rescue analgesic	iv/po analgesic use	up to 10 hours
Primary	The average pain scores	Pain scores were typically recorded on a scale from 0 to 10 by visual analogue scale (VAS), whereas, in children younger than 4 years the FLACC (Face, Legs, Activity, Cry, Consolability) score was used.	up to 10 hours
Secondary	Number of participants with hypotension or bradycardia.	An intra-operative decrease in blood pressure(BP) or heart rate(HR) of more than 20% from preoperative values was defined as hypotension or bradycardia, respectively, and was treated with rapid infusion of fluids or with atropine 0.01 mg/kg.	up to 10 hours
Secondary	Number of participants with hypertension or tachycardia.	An intraoperative increase in BP or HR by more than 20% was defined as insufficient analgesia and was treated with fentanyl 1 mcg/kg iv.	up to 10 hours
Secondary	Incidence of side effects	Nausea, vomiting, respiratory depression	up to 10 hours
Secondary	Time to first mobilization	Time to first mobilization	up to 10 hours
Secondary	Time to first micturition	Time to first micturition	up to 10 hours
Secondary	The length of hospital stay	Hospitalisation, hr	up to 10 hours

External Links

•   Brennan J. Modern day-case anaesthesia for children. Br J Anaesth. 1999;83:91-103.
•   Corliss A, Alyssa A, Timothy J, Danielle A Hamilton. Buffered lidocaine and bupivacaine mixture - the ideal local anesthetic solution? Plast Surg 2015: 23; 2, 87-90
•   Nancy B et al. Regional anesth and Pain Management for the Pediatric Patient. international anesthesiology clinics:2012; 50,4,83-95
•   Suresh S et al. Are Caudal Blocks for Pain Control Safe in Children? An Analysis of 18,650 Caudal Blocks from the Pediatric Regional Anesthesia Network (PRAN) Database. Anesth Analgesia. 2015;120:151-156