Postoperative PainNCT02507700
Popliteal Block for Postoperative Pain in Knee-ankle Soft Tissue Surgery in Cerebral Palsy
A study testing Popliteal block, Sevoflurane and Ultrasound in people with Postoperative Pain and Cerebral Palsy, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Popliteal block is a technique for providing postoperative pain management in children. In this randomized double-blinded study, the investigators evaluated the effects of preoperative popliteal nerve block on postoperative pain and analgesic requirement in children with cerebral palsy (CP) undergoing knee-anckle soft… Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Postoperative Pain, Cerebral Palsy
- What is being tested?
- Popliteal block, Sevoflurane and Ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2015to Jun 2016
- Phase
- Interventional
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with cerebral palsy
- Scheduled for knee and ankle surgery
Who cannot join
- Autonomic neuropathy
- Medication with anticholinergic drugs
- Continuous infusion of vasoactive drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
Ankara, 06110
About this study
Popliteal block is a technique for providing postoperative pain management in children. In this randomized double-blinded study, the investigators evaluated the effects of preoperative popliteal nerve block on postoperative pain and analgesic requirement in children with cerebral palsy (CP) undergoing knee-anckle soft tissue surgery. The Wong Baker faces scale and skin conductance fluctuations will be assessed.
Read the detailed description
Sevoflurane will be used for anesthesia induction and maintance. Laryngeal mask airway will be placed without neuromuscular blocking agent. In group P (popliteal block), a single dose of 0.3ml.kg(-1) of 0.25% bupivacaine will be performed for popiteal nerve block (with ultrasound guidence). In group C ( control), only plaster cover will be applied without nerve block for sham procedure to provide double-blinded study. Intraoperative heart rate, mean arterial pressure, BIS (bispectral index) values, sevoflurane consumption will be recorded ten minutes interval. Wong Baker faces scale and skin conductance fluctuations will be recorded at postoperative 0, 10th min, 20th min , 1st h, 4th h, 12th h qnd 24th h. Total analgesic consumption (paracetamol orally ) will be recorded.
- Conditions
- Postoperative Pain, Cerebral Palsy
- Being tested
- Popliteal block, Sevoflurane, Ultrasound, Plaster cover, bupivacaine
- Keywords
- nerve block
- Medical subject headings
- Pain, Postoperative, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Popliteal blockProcedure or surgery
In group P, popliteal block will be performed with ultrasound guidence.
SevofluraneDrug
Sevoflurane will be used to all patient's for anesthesia induction and maintenance
UltrasoundDevice
For recognize the nerve (sciatic nerve), ultrasound will be used in group P.
Plaster coverOther
Plaster cover will be used to control group for sham procedure
bupivacaineDrug
Bupivacaine 0.25% will be performed for popliteal block to group P.
Laryngeal mask airwayOther
After anesthesia induction, laryngeal mask airway will be inserted to all patients
| Study group | Role | What they receive |
|---|---|---|
| popliteal block | Active comparator | Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine. Receives: Procedure: Popliteal block; Drug: Sevoflurane; Device: Ultrasound; Drug: bupivacaine; Other: Laryngeal mask airway |
| Plaster cover | Sham comparator | Only plaster cover will be applied without nerve block for sham procedure. Receives: Drug: Sevoflurane; Other: Plaster cover; Other: Laryngeal mask airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain assessment via Wong Baker faces scale
Measured: The patients will be followed up to 24 hours
The number of fluctuations of skin conductance per second (NFSC).
Measured: The patients will be followed up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionJun 2016
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 Postoperative PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, derya özkan, Diskapi Teaching and Research Hospital
- Investigators
- Taylan Akkaya, Study chair, Ministry of Health Diskapi Yıldırım Beyazıt Training and Research HospitalMesut Bakır, Study chair, Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507700
- Sponsor's protocol ID
- DiskapiTRH 2015
- Status last verified
- Jun 2016
- First submitted
- 15 Jul 2015
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ledowski T, Bromilow J, Wu J, Paech MJ, Storm H, Schug SA. The assessment of postoperative pain by monitoring skin conductance: results of a prospective study. Anaesthesia. 2007 Oct;62(10):989-93. doi: 10.1111/j.1365-2044.2007.05191.x.
PubMed 17845649Johnston BM, Gunn TR, Gluckman PD. Surface cooling rapidly induces coordinated activity in the upper and lower airway muscles of the fetal lamb in utero. Pediatr Res. 1988 Mar;23(3):257-61. doi: 10.1203/00006450-198803000-00005.
PubMed 3353170Ozkan D, Gonen E, Akkaya T, Bakir M. Popliteal block for lower limb surgery in children with cerebral palsy: effect on sevoflurane consumption and postoperative pain (a randomized, double-blinded, controlled trial). J Anesth. 2017 Jun;31(3):358-364. doi: 10.1007/s00540-017-2318-2. Epub 2017 Feb 14.
PubMed 28197774
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Popliteal Block for Postoperative Pain in Knee-ankle Soft Tissue Surgery in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02507700
- Acronym / sponsor ID
- DiskapiTRH 2015
- Conditions
- Postoperative Pain, Cerebral Palsy
- Keywords
- nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Jul 2015 (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.
Popliteal block is a technique for providing postoperative pain management in children. In this randomized double-blinded study, the investigators evaluated the effects of preoperative popliteal nerve block on postoperative pain and analgesic requirement in children with cerebral palsy (CP) undergoing knee-anckle soft tissue surgery. The Wong Baker faces scale and skin conductance fluctuations will be assessed.
Detailed description
Sevoflurane will be used for anesthesia induction and maintance. Laryngeal mask airway will be placed without neuromuscular blocking agent. In group P (popliteal block), a single dose of 0.3ml.kg(-1) of 0.25% bupivacaine will be performed for popiteal nerve block (with ultrasound guidence). In group C ( control), only plaster cover will be applied without nerve block for sham procedure to provide double-blinded study. Intraoperative heart rate, mean arterial pressure, BIS (bispectral index) values, sevoflurane consumption will be recorded ten minutes interval. Wong Baker faces scale and skin conductance fluctuations will be recorded at postoperative 0, 10th min, 20th min , 1st h, 4th h, 12th h qnd 24th h. Total analgesic consumption (paracetamol orally ) will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| popliteal block | Active comparator | Procedure: Popliteal block, Drug: Sevoflurane, Device: Ultrasound, Drug: bupivacaine, Other: Laryngeal mask airwayPopliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine. |
| Plaster cover | Sham comparator | Drug: Sevoflurane, Other: Plaster cover, Other: Laryngeal mask airwayOnly plaster cover will be applied without nerve block for sham procedure. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with cerebral palsy
- Scheduled for knee and ankle surgery
Key exclusion criteria (3 listed)
- Autonomic neuropathy
- Medication with anticholinergic drugs
- Continuous infusion of vasoactive drugs
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 |
|---|---|---|
| Popliteal blockIn group P, popliteal block will be performed with ultrasound guidence. | Procedure or surgery | popliteal block |
| SevofluraneSevoflurane will be used to all patient's for anesthesia induction and maintenance | Drug | Plaster cover, popliteal block |
| UltrasoundFor recognize the nerve (sciatic nerve), ultrasound will be used in group P. | Device | popliteal block |
| Plaster coverPlaster cover will be used to control group for sham procedure | Other | Plaster cover |
| bupivacaineBupivacaine 0.25% will be performed for popliteal block to group P. | Drug | popliteal block |
| Laryngeal mask airwayAfter anesthesia induction, laryngeal mask airway will be inserted to all patients | Other | Plaster cover, popliteal block |
Primary outcome
Postoperative pain assessment via Wong Baker faces scale
Time frame: The patients will be followed up to 24 hours
The number of fluctuations of skin conductance per second (NFSC).
Time frame: The patients will be followed up to 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 13 Jun 2016.
- Results publication: PubMed 17845649Ledowski T, Bromilow J, Wu J, Paech MJ, Storm H, Schug SA. The assessment of postoperative pain by monitoring skin conductance: results of a prospective study. Anaesthesia. 2007 Oct;62(10):989-93. doi: 10.1111/j.1365-2044.2007.05191.x.
- Results publication: PubMed 3353170Johnston BM, Gunn TR, Gluckman PD. Surface cooling rapidly induces coordinated activity in the upper and lower airway muscles of the fetal lamb in utero. Pediatr Res. 1988 Mar;23(3):257-61. doi: 10.1203/00006450-198803000-00005.
- Derived from this study: PubMed 28197774Ozkan D, Gonen E, Akkaya T, Bakir M. Popliteal block for lower limb surgery in children with cerebral palsy: effect on sevoflurane consumption and postoperative pain (a randomized, double-blinded, controlled trial). J Anesth. 2017 Jun;31(3):358-364. doi: 10.1007/s00540-017-2318-2. Epub 2017 Feb 14.
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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.
Taylan Akkaya study chair
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
Mesut Bakır study chair
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Popliteal block, Sevoflurane and Ultrasound in people with Postoperative Pain and Cerebral Palsy, run by Diskapi Teaching and Research 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 3 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 13 Jun 2016. 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. Some participants in this study may receive a placebo. 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?
Postoperative pain assessment via Wong Baker faces scale (time frame: The patients will be followed up to 24 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 NCT02507700, 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 13 Jun 2016.