Pain, PostoperativeNCT05979376
Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block
An observational study of Pain, Postoperative, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This prospective double blinded study will be conducted over 60 pediatric patients ASA (American Association of Anesthesiologists) I and II between the age of 1-7 years old, who will be scheduled for unilateral groin surgery. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Pain, Postoperative
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 Apr 2023
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patient children aged 1-7 years
Who may be able to join
- The study included children aged 1-7 years with ASA (American Society of Anesthesiologists) I-II, who underwent elective, unilateral, groin surgery (inguinal hernia, orchiopexy, hydrocele) with the consent of their families
Who cannot join
- Children who were aged outside the range of 1-7 years, with ASA III or higher, allergic to local anesthetics, had an infection in the injection area, had contraindications for regional anesthesia such as coagulopathy, whose families did not give consent, were undergoing laparoscopic orchidopexy, undergoing bilateral surgery, had a body mass index of >30 kg/m2, and were expected to be admitted to the intensive care unit during the postoperative period were excluded from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
PINAR Kendigelen
Istanbul, Please Select, 34098
About this study
Official title: Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block for Paediatric Groin Surgery:A Randomized Double Blind Study
This prospective double blinded study will be conducted over 60 pediatric patients ASA (American Association of Anesthesiologists) I and II between the age of 1-7 years old, who will be scheduled for unilateral groin surgery. Patients will be randomly allocated into 3 study groups: Control group that only received local anesthetics ( bupivacaine) Group II bupivacaine with the dexmetedomidine ( 0,5mcg/kg ) and group III bupivacaine with the dexmedetomidine (1mcg/kg).Patients in all groups will receive quadratus lumborum block.
Bradycardia, hypotension, atropine, and bolus fluid infusion requirements will be recorded. When there was up to a 30% decrease in basal mean blood pressure, a crystalloid infusion bolus will be given at 10 ml/kg. When bradycardia occurred , atropine will be given at a dose of 0.02 mg/kg. Patients will be followed up in the postoperative recovery unit for the first 2 hours, and then in the ward. The RAMSEY sedation scale and WATCHA agitation scale were evaluated at 5, 15, 30, and 60 minutes in the postoperative recovery unit. Nausea, vomiting, and other side effects were recorded if present.
Time to first analgesic requirement ( primary outcome) , FLACC Scale scores will be recorded within 24h postoperatively, total dose of analgesic consumption, incidence of postoperative complications as hypotension, bradycardia, vomiting, pruritis and respiratory depression will be recorded.
- Conditions
- Pain, Postoperative
- Keywords
- dexmedetomidine, bupivacaine, quadratus lumborum block, postoperative pain, regional anesthesia, pediatric anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Control group) | group I: quadratus lumborum block with 0,25% bupivacaine 0,5 ml/kg | |
| Group II | groupII: quadratus lumborum block with 0,25%bupivacaine 0,5 ml/kg and dexmedetomidine 0,5 mcg/kg as an adjuvant | |
| Group III | groupIII: quadratus lumborum block with 0,25% bupivacaine 0,5 ml/kg and dexmedetomidine 1 mcg/kg as an adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to first rescue analgesic requirement
the time to first rescue analgesic requirement within the first 24 postoperative hours,
Measured: 24 hours
Secondary outcomes (4)
postoperative pain scores FLACC (face, legs, activity, cry, and consolability)
postoperative pain assessment score in children (The scale is scored in a range of 0-10 with 0 representing no pain, 10 representing maximum pain)
Measured: 24 hours
additional analgesic consumption
total analgesic consuption within 24 hours
Measured: 24 hours
postoperative sedation scores RAMSEY (Ramsey sedation scale)
patient's sedation scores within postoperative first one hour (Ramsey sedation score is scored in a range of 1-6 with 1 representing awake; agitated or restless, 6 representing Asleep; no response to glabellar tap or loud auditory stimulus)
Measured: 1 hour
incidence of complications
Incidence of intraoperative and postoperative complications or side effects
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Dec 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yagmur Gul, Istanbul University - Cerrahpasa
- Investigators
- PINAR Kendigelen, Prof., Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979376
- Sponsor's protocol ID
- E-83045809-604.01.01-631721
- Status last verified
- Aug 2023
- First submitted
- 29 Jul 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block for Paediatric Groin Surgery:A Randomized Double Blind Study
- ClinicalTrials.gov ID
- NCT05979376
- Acronym / sponsor ID
- E-83045809-604.01.01-631721
- Conditions
- Pain, Postoperative
- Keywords
- dexmedetomidine, bupivacaine, quadratus lumborum block, postoperative pain, regional anesthesia, pediatric anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 7 Aug 2023 (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.
This prospective double blinded study will be conducted over 60 pediatric patients ASA (American Association of Anesthesiologists) I and II between the age of 1-7 years old, who will be scheduled for unilateral groin surgery. Patients will be randomly allocated into 3 study groups: Control group that only received local anesthetics ( bupivacaine) Group II bupivacaine with the dexmetedomidine ( 0,5mcg/kg ) and group III bupivacaine with the dexmedetomidine (1mcg/kg).Patients in all groups will receive quadratus lumborum block.
Bradycardia, hypotension, atropine, and bolus fluid infusion requirements will be recorded. When there was up to a 30% decrease in basal mean blood pressure, a crystalloid infusion bolus will be given at 10 ml/kg. When bradycardia occurred , atropine will be given at a dose of 0.02 mg/kg. Patients will be followed up in the postoperative recovery unit for the first 2 hours, and then in the ward. The RAMSEY sedation scale and WATCHA agitation scale were evaluated at 5, 15, 30, and 60 minutes in the postoperative recovery unit. Nausea, vomiting, and other side effects were recorded if present.
Time to first analgesic requirement ( primary outcome) , FLACC Scale scores will be recorded within 24h postoperatively, total dose of analgesic consumption, incidence of postoperative complications as hypotension, bradycardia, vomiting, pruritis and respiratory depression will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (Control group) | – | –group I: quadratus lumborum block with 0,25% bupivacaine 0,5 ml/kg |
| Group II | – | –groupII: quadratus lumborum block with 0,25%bupivacaine 0,5 ml/kg and dexmedetomidine 0,5 mcg/kg as an adjuvant |
| Group III | – | –groupIII: quadratus lumborum block with 0,25% bupivacaine 0,5 ml/kg and dexmedetomidine 1 mcg/kg as an adjuvant |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patient children aged 1-7 years
Key inclusion criteria (1 listed)
- The study included children aged 1-7 years with ASA (American Society of Anesthesiologists) I-II, who underwent elective, unilateral, groin surgery (inguinal hernia, orchiopexy, hydrocele) with the consent of their families
Key exclusion criteria (1 listed)
- Children who were aged outside the range of 1-7 years, with ASA III or higher, allergic to local anesthetics, had an infection in the injection area, had contraindications for regional anesthesia such as coagulopathy, whose families did not give consent, were undergoing laparoscopic orchidopexy, undergoing bilateral surgery, had a body mass index of >30 kg/m2, and were expected to be admitted to the intensive care unit during the postoperative period were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the time to first rescue analgesic requirement
Time frame: 24 hours
the time to first rescue analgesic requirement within the first 24 postoperative hours,
4 secondary outcomes
postoperative pain scores FLACC (face, legs, activity, cry, and consolability)
Time frame: 24 hours
additional analgesic consumption
Time frame: 24 hours
postoperative sedation scores RAMSEY (Ramsey sedation scale)
Time frame: 1 hour
incidence of complications
Time frame: 24 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 23 Aug 2023.
- Individual participant dataSharing planned: No
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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.
PINAR Kendigelen, Prof. study director
Istanbul University - Cerrahpasa
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 Istanbul University - Cerrahpasa 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 1 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 23 Aug 2023. 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?
the time to first rescue analgesic requirement (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2023.