Anesthesia, LocalNCT03911648
Analgesic Efficacy of Lidocaine Plus Bupivacaine Versus Bupivacaine Alone Caudally
An observational study of Anesthesia, Local, run by Ayancık State Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 2 to 11 years, men only
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- 0.5 ml.kg-1 bupivacaine 0.25% and 0.5 ml.kg-1 bupivacaine 0.25% with the addition of 3 mg/kg lidocaine 1%
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 15 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- Men only
- Child
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.
Who may be able to join
- American Society of Anesthesiologists (ASA) class 1.
- Patient underwent elective circumcision operation under general anesthesia and caudal analgesia.
Who cannot join
- Procedures simultaneously underwent another operation unrelated to circumcision.
- Patients who had unsuccessful caudal block.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Anesthesia, Local
- Being tested
- 0.5 ml.kg-1 bupivacaine 0.25%, 0.5 ml.kg-1 bupivacaine 0.25% with the addition of 3 mg/kg lidocaine 1%
- Keywords
- Bupivacaine, Lidocaine, Caudal block, Pediatric urologic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 ml.kg-1 bupivacaine 0.25%Drug
Also called Marcaine
Caudally
0.5 ml.kg-1 bupivacaine 0.25% with the addition of 3 mg/kg lidocaine 1%Drug
Also called Marcaine, Xylocaine
Caudally
| Study group | Role | What they receive |
|---|---|---|
| Group B; | Patients had 0.5 ml.kg-1 bupivacaine 0.25% caudally, the maximum given volume was 20 ml. N=42 Receives: 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 Receives: Drug: 0.5 ml.kg-1 bupivacaine 0.25% with the addition of 3 mg/kg lidocaine 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who require rescue analgesic
iv/po analgesic use
Measured: 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.
Measured: up to 10 hours
Secondary outcomes (6)
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.
Measured: up to 10 hours
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.
Measured: up to 10 hours
Incidence of side effects
Nausea, vomiting, respiratory depression
Measured: up to 10 hours
Time to first mobilization
Time to first mobilization
Measured: up to 10 hours
Time to first micturition
Time to first micturition
Measured: up to 10 hours
The length of hospital stay
Hospitalisation, hr
Measured: up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Jul 2018
- Primary completion15 Jul 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayancık State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Gulsah Atasever, Ayancık State Hospital
- Investigators
- ayse gulsah atasever, MD, Principal investigator, Ayancık State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911648
- Sponsor's protocol ID
- 2019/366
- Status last verified
- Apr 2019
- First submitted
- 9 Apr 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32401707
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03911648
- Acronym / sponsor ID
- 2019/366
- Conditions
- Anesthesia, Local
- Keywords
- Bupivacaine, Lidocaine, Caudal block, Pediatric urologic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Ayancık State HospitalOther government
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B; | – | Drug: 0.5 ml.kg-1 bupivacaine 0.25%Patients had 0.5 ml.kg-1 bupivacaine 0.25% caudally, the maximum given volume was 20 ml. N=42 |
| Group L; | – | Drug: 0.5 ml.kg-1 bupivacaine 0.25% with the addition of 3 mg/kg lidocaine 1%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 |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- Male only
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) class 1.
- Patient underwent elective circumcision operation under general anesthesia and caudal analgesia.
Key exclusion criteria (2 listed)
- Procedures simultaneously underwent another operation unrelated to circumcision.
- Patients who had unsuccessful caudal block.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5 ml.kg-1 bupivacaine 0.25%Also: MarcaineCaudally | Drug | Group B; |
| 0.5 ml.kg-1 bupivacaine 0.25% with the addition of 3 mg/kg lidocaine 1%Also: Marcaine, XylocaineCaudally | Drug | Group L; |
Primary outcome
Number of patients who require rescue analgesic
Time frame: up to 10 hours
iv/po analgesic use
The average pain scores
Time frame: up to 10 hours
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.
6 secondary outcomes
Number of participants with hypotension or bradycardia.
Time frame: up to 10 hours
Number of participants with hypertension or tachycardia.
Time frame: up to 10 hours
Incidence of side effects
Time frame: up to 10 hours
Time to first mobilization
Time frame: up to 10 hours
Time to first micturition
Time frame: up to 10 hours
The length of hospital stay
Time frame: up to 10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Derived from this study: PubMed 32401707Atasever 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.
- Brennan J. Modern day-case anaesthesia for children. Br J Anaesth. 1999;83:91-103.Link provided by the sponsor.
- 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;120:151-156Link provided by the sponsor.
- Nancy B et al. Regional anesth and Pain Management for the Pediatric Patient. ınternatıonal anesthesıology clınıcs:2012; 50,4,83-95Link provided by the sponsor.
- Corliss A, Alyssa A, Timothy J, Danielle A Hamilton. Buffered lidocaine and bupivacaine mixture - the ideal local anesthetic solution? Plast Surg 2015: 23; 2, 87-90Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ayse gulsah atasever, MD principal investigator
Ayancık State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Local, run by Ayancık State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who require rescue analgesic (time frame: up to 10 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03911648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.