Analgesic Efficacy of Lidocaine Plus Bupivacaine Versus Bupivacaine Alone Caudally

NCT ID: NCT03911648

Last Updated: 2019-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2018-08-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthesia, Local

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group B;

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

0.5 ml.kg-1 bupivacaine 0.25%

Intervention Type DRUG

Caudally

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

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

Intervention Type DRUG

Caudally

Interventions

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0.5 ml.kg-1 bupivacaine 0.25%

Caudally

Intervention Type DRUG

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

Caudally

Intervention Type DRUG

Other Intervention Names

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Marcaine Marcaine, Xylocaine

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ayancık State Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ayse Gulsah Atasever

Resident Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ayse gulsah atasever, MD

Role: PRINCIPAL_INVESTIGATOR

Ayancık State Hospital

Locations

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Ayancık State Hospital

Sinop, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 32401707 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/?term=Are+Caudal+Blocks+for+Pain+Control+Safe+in+Children%3F+An+Analysis+of+18%2C650+Caudal+Blocks+from+the+Pediatric+Regional+Anesthesia+Network+(PRAN)+Database.+Anesth+Analg.+2015%3B

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

https://www.semanticscholar.org/paper/Regional-anesthesia-and-pain-management-for-the-Samol-Furstein/63c57069b2fe3354f6c78d4d7d08c8a550b7868a

Nancy B et al. Regional anesth and Pain Management for the Pediatric Patient. ınternatıonal anesthesıology clınıcs:2012; 50,4,83-95

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4459414/

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

Other Identifiers

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2019/366

Identifier Type: -

Identifier Source: org_study_id

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