Pain, PostoperativeNCT01974843
Caudal Block With Tramadol and Levobupivacaine or Bupivacaine
An observational study of Pain, Postoperative, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
Caudal block is the regional anesthetic technique that is used most frequently in pediatric surgery. Opioid drugs have been added to local anesthetic solutions to prolong duration of analgesia but ideal combination were not found that has minimal adverse effect. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Levobupivacaine and Bupivacaine
- Type of treatment
- Injection or infusion
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Jan 2013
- How long will I take part?
- 1 Day
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Study population: ASA status I children aged 2 to 7 years who were scheduled for elective inguinal herniorrhaphy or orchidopexy were enrolled.
Who may be able to join
- ASA I,
- 2 to 7 years old children
- Elective inguinal herniorrhaphy or orchidopexy operation
Who cannot join
- Infection at the site of block, bleeding diathesis, pre-existing neurological or spinal disease, or abnormalities of the sacrum) or with a known allergy to local anesthetics were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce University Medicine School, Anesthesiology and Reanimation Department
Düzce, 81620
About this study
Official title: The Assessment of Bupivacaine-tramadol and Levobupivacaine-tramadol Combinations for Preemptive Caudal Anaesthesia in Children: a Randomized, Double-blind, Prospective Study
Caudal block is the regional anesthetic technique that is used most frequently in pediatric surgery. Opioid drugs have been added to local anesthetic solutions to prolong duration of analgesia but ideal combination were not found that has minimal adverse effect. The aim of this study was to compare the postoperative analgesic efficacy of equal concentrations of bupivacaine plus tramadol or levobupivacaine plus tramadol in pediatric patients undergoing minor urological surgery.
Read the detailed description
Sixty-eight children aged 2 to 7 years who were undergoing inguinal herniorrhaphy or orchidopexy received bupivacaine 0.25% plus tramadol 2 mg/kg (BT group) or levobupivacaine 0.25% plus tramadol 2 mg/kg (LT group) by the caudal route after laryngeal mask anesthesia. The primary outcome of the study was to compare the duration and quality of postoperative analgesia. The postoperative pain relief was evaluated by the Children and Infants Postoperative Pain Scale (CHIPPS) at 2, 4, 6, 12, and 24 h postoperatively. In addition, the time of first analgesic requirement was noted.
- Conditions
- Pain, Postoperative
- Being tested
- Levobupivacaine, Bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Chirocaine, Abbott Lab, Nycomed Pharma, Norway
in the levobupivacaine-tramadol (LT) group received a caudal injection of levobupivacaine 0.25% plus tramadol 2 mg/kg (maximum doses; 35 mg levobupivacaine plus 35 mg tramadol), resulting in a total volume of 1 ml/kg at maximum volume of 15 ml
BupivacaineDrug
Also called Marcaine, Astra Zeneca, UK
in the bupivacaine-tramadol (BT) group received a caudal injection of bupivacaine 0.25% plus tramadol 2 mg/kg (maximum doses; 35 mg bupivacaine plus 35 mg tramadol)
| Study group | Role | What they receive |
|---|---|---|
| Group BT | Bupivacaine-tramadol (BT) group received a caudal injection of bupivacaine 0.25% plus tramadol 2 mg/kg Receives: Drug: Bupivacaine | |
| Group LT | Levobupivacaine-tramadol (LT) group received a caudal injection of levobupivacaine 0.25% plus tramadol 2 mg/kg, resulting in a total volume of 1 ml/kg. Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of postoperative analgesia
The postoperative pain relief was evaluated by the Children and Infants Postoperative Pain Scale (CHIPPS) at 2, 4, 6, 12, and 24 h postoperatively. In addition, the time of first analgesic requirement was noted.
Measured: Postopertively 24 h
Secondary outcomes (1)
Adverse effect
All patients were observed in the hospital for at least 24 h because of the possible side effects of caudal blocks.
Measured: Postoperatively at 2, 4, 6, 12, and 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startJan 2011
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gulbin sezen, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974843
- Sponsor's protocol ID
- DZC-160
- Status last verified
- Feb 2014
- First submitted
- 23 Oct 2013
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Silvani P, Camporesi A, Agostino MR, Salvo I. Caudal anesthesia in pediatrics: an update. Minerva Anestesiol. 2006 Jun;72(6):453-9.
PubMed 16682915Locatelli B, Ingelmo P, Sonzogni V, Zanella A, Gatti V, Spotti A, Di Marco S, Fumagalli R. Randomized, double-blind, phase III, controlled trial comparing levobupivacaine 0.25%, ropivacaine 0.25% and bupivacaine 0.25% by the caudal route in children. Br J Anaesth. 2005 Mar;94(3):366-71. doi: 10.1093/bja/aei059. Epub 2004 Dec 17.
PubMed 15608043Yildiz TS, Ozdamar D, Bagus F, Solak M, Toker K. Levobupivacaine-tramadol combination for caudal block in children: a randomized, double-blinded, prospective study. Paediatr Anaesth. 2010 Jun;20(6):524-9. doi: 10.1111/j.1460-9592.2010.03296.x. Epub 2010 Apr 14.
PubMed 20412459
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Bupivacaine-tramadol and Levobupivacaine-tramadol Combinations for Preemptive Caudal Anaesthesia in Children: a Randomized, Double-blind, Prospective Study
- ClinicalTrials.gov ID
- NCT01974843
- Acronym / sponsor ID
- DZC-160
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Nov 2013 (estimated)
- 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.
Caudal block is the regional anesthetic technique that is used most frequently in pediatric surgery. Opioid drugs have been added to local anesthetic solutions to prolong duration of analgesia but ideal combination were not found that has minimal adverse effect. The aim of this study was to compare the postoperative analgesic efficacy of equal concentrations of bupivacaine plus tramadol or levobupivacaine plus tramadol in pediatric patients undergoing minor urological surgery.
Detailed description
Sixty-eight children aged 2 to 7 years who were undergoing inguinal herniorrhaphy or orchidopexy received bupivacaine 0.25% plus tramadol 2 mg/kg (BT group) or levobupivacaine 0.25% plus tramadol 2 mg/kg (LT group) by the caudal route after laryngeal mask anesthesia. The primary outcome of the study was to compare the duration and quality of postoperative analgesia. The postoperative pain relief was evaluated by the Children and Infants Postoperative Pain Scale (CHIPPS) at 2, 4, 6, 12, and 24 h postoperatively. In addition, the time of first analgesic requirement was noted.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group BT | – | Drug: BupivacaineBupivacaine-tramadol (BT) group received a caudal injection of bupivacaine 0.25% plus tramadol 2 mg/kg |
| Group LT | – | Drug: LevobupivacaineLevobupivacaine-tramadol (LT) group received a caudal injection of levobupivacaine 0.25% plus tramadol 2 mg/kg, resulting in a total volume of 1 ml/kg. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- ASA status I children aged 2 to 7 years who were scheduled for elective inguinal herniorrhaphy or orchidopexy were enrolled.
Key inclusion criteria (3 listed)
- ASA I,
- 2 to 7 years old children
- Elective inguinal herniorrhaphy or orchidopexy operation
Key exclusion criteria (1 listed)
- Infection at the site of block, bleeding diathesis, pre-existing neurological or spinal disease, or abnormalities of the sacrum) or with a known allergy to local anesthetics were excluded.
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 |
|---|---|---|
| LevobupivacaineAlso: Chirocaine, Abbott Lab, Nycomed Pharma, Norwayin the levobupivacaine-tramadol (LT) group received a caudal injection of levobupivacaine 0.25% plus tramadol 2 mg/kg (maximum doses; 35 mg levobupivacaine plus 35 mg tramadol), resulting in a total volume of 1 ml/kg at maximum volume of 15 ml | Drug | Group LT |
| BupivacaineAlso: Marcaine, Astra Zeneca, UKin the bupivacaine-tramadol (BT) group received a caudal injection of bupivacaine 0.25% plus tramadol 2 mg/kg (maximum doses; 35 mg bupivacaine plus 35 mg tramadol) | Drug | Group BT |
Primary outcome
Quality of postoperative analgesia
Time frame: Postopertively 24 h
The postoperative pain relief was evaluated by the Children and Infants Postoperative Pain Scale (CHIPPS) at 2, 4, 6, 12, and 24 h postoperatively. In addition, the time of first analgesic requirement was noted.
1 secondary outcome
Adverse effect
Time frame: Postoperatively at 2, 4, 6, 12, and 24 h
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 7 Feb 2014.
- Background: PubMed 16682915Silvani P, Camporesi A, Agostino MR, Salvo I. Caudal anesthesia in pediatrics: an update. Minerva Anestesiol. 2006 Jun;72(6):453-9.
- Background: PubMed 15608043Locatelli B, Ingelmo P, Sonzogni V, Zanella A, Gatti V, Spotti A, Di Marco S, Fumagalli R. Randomized, double-blind, phase III, controlled trial comparing levobupivacaine 0.25%, ropivacaine 0.25% and bupivacaine 0.25% by the caudal route in children. Br J Anaesth. 2005 Mar;94(3):366-71. doi: 10.1093/bja/aei059. Epub 2004 Dec 17.
- Background: PubMed 20412459Yildiz TS, Ozdamar D, Bagus F, Solak M, Toker K. Levobupivacaine-tramadol combination for caudal block in children: a randomized, double-blinded, prospective study. Paediatr Anaesth. 2010 Jun;20(6):524-9. doi: 10.1111/j.1460-9592.2010.03296.x. Epub 2010 Apr 14.
- caudal block usage in pediatric patientsLink provided by the sponsor.
- performing of caudal block in pediatric patientsLink 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pain, Postoperative, run by Duzce University 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 3 inclusion and 1 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 7 Feb 2014. 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?
Quality of postoperative analgesia (time frame: Postopertively 24 h). 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 NCT01974843, which also lists 3 linked publications.
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 7 Feb 2014.