Recovery After Cleft Palate SurgeryPhase 2/3NCT02923869
Comparative Study Between Levobupivacaine and Bupivacaine for Nerve Block During Pediatric Primary Cleft Palate Surgery
A Phase 2/3 study testing Levobupivacaine and Bupivacaine in people with Recovery After Cleft Palate Surgery, run by Assiut University at 1 site in Egypt.
Trial summary
A cleft deformity of the lip and/or palate is one of the commonest major birth defects. Primary surgery of cleft palates (CP) varies according to the different surgical teams. Its peculiarity lies in the numerous care management protocols proposed according to the surgical techniques used, operating time (between M3… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Recovery After Cleft Palate Surgery
- What is being tested?
- Levobupivacaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Oct 2016
- Phase
- Phase 2/3
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-10 years
- Both sexes
- ASA I or II
- Primary cleft palate
Who cannot join
- Any allergy to local anesthetics
- Coagulation disorders
- Local infection or injury at site of MNB
- Concomitant rhinoplasty
- Associated other congenital anomalies
- History of upper or lower airway diseases
- History of sleep apnea
Trial locations and contacts
1 site in 1 country.
About this study
A cleft deformity of the lip and/or palate is one of the commonest major birth defects.
Primary surgery of cleft palates (CP) varies according to the different surgical teams. Its peculiarity lies in the numerous care management protocols proposed according to the surgical techniques used, operating time (between M3 and M18 of life), anesthetic technique and postoperative management.
Read more
This surgery must be associated to a specific care management because of potential associated complications, especially the risk of obstruction of the upper respiratory tract and respiratory distress majored by the use of morphine anesthetics during and after surgery.
Adequate postoperative analgesia in children is a vital part of perioperative care. Regional block given preoperatively in combination with general anesthesia (GA) provides good preemptive analgesia. It is associated with perioperative hemodynamic stability, rapid and complete recovery and reduced analgesic requirement in the postoperative period.
CP repair is painful, necessitating high doses of intravenous (IV) opioids. Therefore, the risk of postoperative respiratory depression and airway obstruction is important, and continuous monitoring is required during the initial 24-h postoperative period. Cleft palate surgery is not only painful, but may also compromise the airway, particularly in children with craniofacial syndromes. Opiate analgesia has the potential to further compromise the airway, whereas bilateral maxillary nerve block can provide analgesia without the risk of respiratory depression in these vulnerable patients. Bilateral maxillary nerve block is performed using a suprazygomatic approach and is based on a computer tomography study.
The nerve supply to the hard and soft palate is from the greater and lesser palatine nerves passing through the sphenopalatine ganglion. The maxillary nerve (MN) provides sensory innervation of the anterior and posterior palate, the upper dental arch, the maxillary sinus, and the posterior nasal cavity. Maxillary nerve block (MNB) through the infrazygomatic route, used for the treatment of trigeminal neuralgia in adults, permits anesthesia of the entire palatine territory. However, this nerve block has led to complications such as orbital puncture, intracranial injection, maxillary artery puncture, or posterior pharyngeal wall injury.
Read the detailed description
A prospective randomized controlled double blind study using a computer generated randomization scheme will be conducted in Assiut University Hospitals and will be carried out on 60 children undergoing primary cleft palate repair surgery. Combined general anesthesia and regional bilateral maxillary nerve block (MNB) will be used for anesthesia in these surgeries.
The study drugs (used in MNB) and randomization will be prepared by the second anesthetist. The MNB and observed parameters (intraoperative and postoperative) will be done by the first anesthetist.
Children will be randomly allocated into one of two groups of 30 patients each:
Group L: children will receive 0.15 ml/kg of 0.2% Levobupivacaine
Group B: children will receive 0.15 ml/kg of 0.2% Bupivacaine
Preoperative Assessment
The day prior to surgery, all children participating in this study will undergo pre-anesthetic checkup (preoperative fitness) including detailed history from the parents, thorough general, physical and systematic examinations. Weight and height of all children will be carefully recorded.
Anesthetic Technique
Premedication: All children will be premedicated with intramuscular midazolam 0.05 mg/kg 10-20 minutes before induction of general anesthesia.
Monitoring: Pulse Oxymetry (SaO2), Non-Invasive Mean Arterial Blood Pressure (MABP), ECG, End Tidal CO2 (EtCO2) and Non-Invasive Temperature probes will be applied to each patient.
After 3 minutes of 100% pre-oxygenation, general anesthesia will be induced by Sevoflurane inhalation 4-6% MAC via facemask then intravenous line will be secured and intravenous fluids (NaCl 0.9%) will be started at the calculated volume and rate. Fentanyl 1 µg/kg and Propofol 1.5 mg/kg will be given intravenously then intubation with oral RAE tube of the appropriate size will be inserted and secured. Assisted ventilation will be adjusted to maintain 30-35 mmHg EtCO2. Anesthesia will be maintained with 100% O2 and Sevoflurane 2-4% MAC. Broad spectrum antibiotic will be given to each child participated in the study.
Suprazygomatic MNB: Bilateral suprazygomatic MNB will be performed after complete aseptic preparation of the skin and before surgery in an anesthetized patient. Success of MNB will be assessed by the lack of sympathetic response to surgical stimulation.
Data Collection
Demographic data: including age, sex, weight and height.
Intraoperative data: heart rate (HR), mean arterial pressure (MAP), ECG, SaO2, EtCO2 and Sevoflurane MAC % will be measured every 15 minutes after MNB till the end of the surgery.
Postoperative data: HR, MAP, SaO2 and respiratory rate (RR) will be measured at the same times of pain assessment times.
Pain Severity: pain will be assessed by the second anesthetist blinded to the study drug used. Pain score will be evaluated on arrival to recovery room (T0), 1, 2, 4, 6, 8, 12 and 24 hours using the FLACC pain scale (Face, Legs, Activity, Cry and Consolability scale). If FLACC score ≥ 3, IV nalbuphine 0.1 mg/kg will be given for supplemental analgesia.
Time of the first analgesic requirement, total dose of nalbuphine consumption or any adverse effects (sedation, vomiting, respiratory depression, bleeding at the puncture site or any systemic toxicity related to the local anesthetic) will also be recorded.
Sedation score: will be evaluated by the 4 points (1-4) score. (Awake and alert -1, Sedated and responding to verbal command-2, Sedated and responding to mild stimulus-3, Sedated and responding to moderate to severe physical stimulus-4).
Blood glucose level will be measured before MNB, 15 minutes after block and 2 hours after end of surgery.
Statistical Analysis
All data will be collected and processed using SPSS (SPSS Inc., Chicago, Illinois, USA) version 20. All results will be expressed as mean ± SD, range, numbers and percentages. Categorical data will be compared using Chi-Square test. Non parametric data will be compared using the Mann-Whitney U test. Numerical data will be compared using the Independent Samples Student t-Test. P ˂ 0.05 will be considered significant.
- Conditions
- Recovery After Cleft Palate Surgery
- Being tested
- Levobupivacaine, Bupivacaine
- Keywords
- Levobupivacaine, Bupivacaine, Nerve Block, Cleft Palate
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Children will receive 0.15 ml/kg of 0.2% Levobupivacaine through bilateral suprazygomatic MNB.
BupivacaineDrug
Children will receive 0.15 ml/kg of 0.2% Bupivacaine through bilateral suprazygomatic MNB.
| Study group | Role | What they receive |
|---|---|---|
| Group L | Active comparator | Children will receive 0.15 ml/kg of 0.2% Levobupivacaine Receives: Drug: Levobupivacaine |
| Group B | Active comparator | Children will receive 0.15 ml/kg of 0.2% Bupivacaine Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
recovery after surgery
sedation of the child in the recovery room will be monitored
Measured: 2 hours
Secondary outcomes (2)
FLACC score
Nalbuphine will be given when visual analogue score ≥ 3
Measured: 24 hours
Intraoperative and Postoperative Complications
percentage of patients with any complications will be recorded
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 posted5 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery After Cleft Palate SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMED F. MOSTAFA, Assiut University
- Investigators
- HAMDY A YOUSSEF, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923869
- Sponsor's protocol ID
- SMB Levobupivacaine
- Status last verified
- Sep 2017
- First submitted
- 30 Sep 2016
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Levobupivacaine and Bupivacaine for Nerve Block During Pediatric Primary Cleft Palate Surgery
- ClinicalTrials.gov ID
- NCT02923869
- Acronym / sponsor ID
- SMB Levobupivacaine
- Conditions
- Recovery After Cleft Palate Surgery
- Keywords
- Levobupivacaine, Bupivacaine, Nerve Block, Cleft Palate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Oct 2016 (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.
A cleft deformity of the lip and/or palate is one of the commonest major birth defects.
Primary surgery of cleft palates (CP) varies according to the different surgical teams. Its peculiarity lies in the numerous care management protocols proposed according to the surgical techniques used, operating time (between M3 and M18 of life), anesthetic technique and postoperative management.
This surgery must be associated to a specific care management because of potential associated complications, especially the risk of obstruction of the upper respiratory tract and respiratory distress majored by the use of morphine anesthetics during and after surgery.
Adequate postoperative analgesia in children is a vital part of perioperative care. Regional block given preoperatively in combination with general anesthesia (GA) provides good preemptive analgesia. It is associated with perioperative hemodynamic stability, rapid and complete recovery and reduced analgesic requirement in the postoperative period.
CP repair is painful, necessitating high doses of intravenous (IV) opioids. Therefore, the risk of postoperative respiratory depression and airway obstruction is important, and continuous monitoring is required during the initial 24-h postoperative period. Cleft palate surgery is not only painful, but may also compromise the airway, particularly in children with craniofacial syndromes. Opiate analgesia has the potential to further compromise the airway, whereas bilateral maxillary nerve block can provide analgesia without the risk of respiratory depression in these vulnerable patients. Bilateral maxillary nerve block is performed using a suprazygomatic approach and is based on a computer tomography study.
The nerve supply to the hard and soft palate is from the greater and lesser palatine nerves passing through the sphenopalatine ganglion. The maxillary nerve (MN) provides sensory innervation of the anterior and posterior palate, the upper dental arch, the maxillary sinus, and the posterior nasal cavity. Maxillary nerve block (MNB) through the infrazygomatic route, used for the treatment of trigeminal neuralgia in adults, permits anesthesia of the entire palatine territory. However, this nerve block has led to complications such as orbital puncture, intracranial injection, maxillary artery puncture, or posterior pharyngeal wall injury.
Detailed description
A prospective randomized controlled double blind study using a computer generated randomization scheme will be conducted in Assiut University Hospitals and will be carried out on 60 children undergoing primary cleft palate repair surgery. Combined general anesthesia and regional bilateral maxillary nerve block (MNB) will be used for anesthesia in these surgeries.
The study drugs (used in MNB) and randomization will be prepared by the second anesthetist. The MNB and observed parameters (intraoperative and postoperative) will be done by the first anesthetist.
Children will be randomly allocated into one of two groups of 30 patients each:
Group L: children will receive 0.15 ml/kg of 0.2% Levobupivacaine
Group B: children will receive 0.15 ml/kg of 0.2% Bupivacaine
Preoperative Assessment
The day prior to surgery, all children participating in this study will undergo pre-anesthetic checkup (preoperative fitness) including detailed history from the parents, thorough general, physical and systematic examinations. Weight and height of all children will be carefully recorded.
Anesthetic Technique
Premedication: All children will be premedicated with intramuscular midazolam 0.05 mg/kg 10-20 minutes before induction of general anesthesia.
Monitoring: Pulse Oxymetry (SaO2), Non-Invasive Mean Arterial Blood Pressure (MABP), ECG, End Tidal CO2 (EtCO2) and Non-Invasive Temperature probes will be applied to each patient.
After 3 minutes of 100% pre-oxygenation, general anesthesia will be induced by Sevoflurane inhalation 4-6% MAC via facemask then intravenous line will be secured and intravenous fluids (NaCl 0.9%) will be started at the calculated volume and rate. Fentanyl 1 µg/kg and Propofol 1.5 mg/kg will be given intravenously then intubation with oral RAE tube of the appropriate size will be inserted and secured. Assisted ventilation will be adjusted to maintain 30-35 mmHg EtCO2. Anesthesia will be maintained with 100% O2 and Sevoflurane 2-4% MAC. Broad spectrum antibiotic will be given to each child participated in the study.
Suprazygomatic MNB: Bilateral suprazygomatic MNB will be performed after complete aseptic preparation of the skin and before surgery in an anesthetized patient. Success of MNB will be assessed by the lack of sympathetic response to surgical stimulation.
Data Collection
Demographic data: including age, sex, weight and height.
Intraoperative data: heart rate (HR), mean arterial pressure (MAP), ECG, SaO2, EtCO2 and Sevoflurane MAC % will be measured every 15 minutes after MNB till the end of the surgery.
Postoperative data: HR, MAP, SaO2 and respiratory rate (RR) will be measured at the same times of pain assessment times.
Pain Severity: pain will be assessed by the second anesthetist blinded to the study drug used. Pain score will be evaluated on arrival to recovery room (T0), 1, 2, 4, 6, 8, 12 and 24 hours using the FLACC pain scale (Face, Legs, Activity, Cry and Consolability scale). If FLACC score ≥ 3, IV nalbuphine 0.1 mg/kg will be given for supplemental analgesia.
Time of the first analgesic requirement, total dose of nalbuphine consumption or any adverse effects (sedation, vomiting, respiratory depression, bleeding at the puncture site or any systemic toxicity related to the local anesthetic) will also be recorded.
Sedation score: will be evaluated by the 4 points (1-4) score. (Awake and alert -1, Sedated and responding to verbal command-2, Sedated and responding to mild stimulus-3, Sedated and responding to moderate to severe physical stimulus-4).
Blood glucose level will be measured before MNB, 15 minutes after block and 2 hours after end of surgery.
Statistical Analysis
All data will be collected and processed using SPSS (SPSS Inc., Chicago, Illinois, USA) version 20. All results will be expressed as mean ± SD, range, numbers and percentages. Categorical data will be compared using Chi-Square test. Non parametric data will be compared using the Mann-Whitney U test. Numerical data will be compared using the Independent Samples Student t-Test. P ˂ 0.05 will be considered significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | Active comparator | Drug: LevobupivacaineChildren will receive 0.15 ml/kg of 0.2% Levobupivacaine |
| Group B | Active comparator | Drug: BupivacaineChildren will receive 0.15 ml/kg of 0.2% Bupivacaine |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 1-10 years
- Both sexes
- ASA I or II
- Primary cleft palate
Key exclusion criteria (7 listed)
- Any allergy to local anesthetics
- Coagulation disorders
- Local infection or injury at site of MNB
- Concomitant rhinoplasty
- Associated other congenital anomalies
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 |
|---|---|---|
| LevobupivacaineChildren will receive 0.15 ml/kg of 0.2% Levobupivacaine through bilateral suprazygomatic MNB. | Drug | Group L |
| BupivacaineChildren will receive 0.15 ml/kg of 0.2% Bupivacaine through bilateral suprazygomatic MNB. | Drug | Group B |
Primary outcome
recovery after surgery
Time frame: 2 hours
sedation of the child in the recovery room will be monitored
2 secondary outcomes
FLACC score
Time frame: 24 hours
Intraoperative and Postoperative 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 7 Sep 2017.
- Individual participant dataSharing planned: Undecided
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.
HAMDY A YOUSSEF, MD study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Levobupivacaine and Bupivacaine in people with Recovery After Cleft Palate Surgery, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 7 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 Sep 2017. 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
recovery after surgery (time frame: 2 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 7 Sep 2017.