Analgesic Efficacy of Lidocaine Plus Bupivacaine Versus Bupivacaine Alone Caudally

NCT03911648 | Completed

• 1 other identifier: 2019/366
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Local

Keywords

Bupivacaine; Lidocaine; Caudal block; Pediatric urologic surgery

Outcome Measures

Primary Outcomes (2)

• Number of patients who require rescue analgesic

  iv/po analgesic use

  up to 10 hours

• 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 Outcomes (6)

• Number of participants with hypotension or bradycardia.

  up to 10 hours

• Number of participants with hypertension or tachycardia.

  up to 10 hours

• Incidence of side effects

  up to 10 hours

• Time to first mobilization

  up to 10 hours

• Time to first micturition

  up to 10 hours

Study Arms (2)

Group B;

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

Drug: 0.5 ml.kg-1 bupivacaine 0.25%

Group L;

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

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

Interventions

0.5 ml.kg-1 bupivacaine 0.25% DRUG

Caudally

Also known as: Marcaine

Group B;

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

Caudally

Also known as: Marcaine, Xylocaine

Group L;

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: male
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The medical records of pediatric patients who underwent circumcision under general anethesia with caudal block over 6 months (01 January 2018-31 June 2018) were analysed.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ayancık State Hospital: lead

Study Sites (1)

Ayancık State Hospital

Sinop, 57600, Turkey (Türkiye)

Location

Related Publications (1)

• Atasever AG, Ermis O, Demir BS, Kasali K, Karadeniz MS. Comparison of bupivacaine alone and in a combination with lidocaine for caudal block in patients undergoing circumcision: A historical cohort study. Turk J Urol. 2019 Nov 29;46(3):243-248. doi: 10.5152/tud.2019.19191. Print 2020 May.

  PMID: 32401707 DERIVED

Related Links

• Brennan J. Modern day-case anaesthesia for children. Br J Anaesth. 1999;83:91-103.
• 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
• Nancy B et al. Regional anesth and Pain Management for the Pediatric Patient. ınternatıonal anesthesıology clınıcs:2012; 50,4,83-95
• 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

MeSH Terms

Interventions

Bupivacaine; Lidocaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Study Officials

• ayse gulsah atasever, MD

  Ayancık State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Anesthesiologist

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: July 1, 2018
• Primary Completion: July 15, 2018
• Study Completion: August 15, 2018
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

TU (1)