Postoperative PainNCT04467463
Peripheral Nerve Block Techniques During Cleft Palate
A study testing peripheral nerve block by 0.25% levobupivacaine in people with Postoperative Pain, run by Cairo University at 2 sites in Egypt.
Trial summary
Regional blocks are commonly used in pediatric anesthesia to achieve adequate postoperative analgesia. Suprazygomatic Maxillary nerve block (SMN) and Greater Palatine nerve block (GPN) are regional blocks described for use during cleft palate (CP) repair surgery.The aim of this study was to compare the analgesic… Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- peripheral nerve block by 0.25% levobupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2020to Dec 2020
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I-III scheduled to undergo palatoplasty
Who cannot join
- bleeding disorders,
- skin lesions or wounds at site of proposed needle insertion,
- congenital heart disease,
- respiratory or
- cardiovascular disorders,
- children scheduled for combined procedures like palatoplasty with cheiloplasty or submucosal alveolar bone grafting,
- known hypersensitivity to local anesthetics or opioids and
- lack of parental consent.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Recruiting
Cairo University hospitals
Cairo, Manial, 12511
Ayman Hussam, M.D., 01004389020, Ahhussam@yahoo.com
- Completed
anesthesia department at Cairo University
Cairo
About this study
Official title: Comparing Two Peripheral Nerve Block Techniques for Perioperative Analgesia During Cleft Palate Surgery in Pediatric Patients: Randomized Controlled Trial
Regional blocks are commonly used in pediatric anesthesia to achieve adequate postoperative analgesia. Suprazygomatic Maxillary nerve block (SMN) and Greater Palatine nerve block (GPN) are regional blocks described for use during cleft palate (CP) repair surgery.The aim of this study was to compare the analgesic effect as well as the incidence of complications associated with the use of bilateral GPN and bilateral SMN blocks in children undergoing palatoplasty surgery.
- Conditions
- Postoperative Pain
- Being tested
- peripheral nerve block by 0.25% levobupivacaine
- Keywords
- Suprazygomatic, Maxillary, Palatine, Cleft Palate
- Medical subject headings
- Pain, Postoperative, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral nerve block by 0.25% levobupivacaineProcedure or surgery
SUBMANDIBULAR nerve block will be performed using a 25G 90 mm beveled needle . the entry point of the needle will be situated at the angle formed by the superior edge of the zygomatic arch below and the posterior orbital rim forward .The needle will be inserted perpendicular to the skin and advanced approximately 20 mm depth to reach the greater wing of the sphenoid deep to the pterygopalatine fossa. Injection of 1ml of 0.25% levobupivacaine will be done over 20 seconds afterensuring negative blood aspiration .greater Palatine Nerve will be blocked bilaterally as it leaves on palatal side through the foramen on the opposite direction of the anterior part of the 3rd molar orthe posterior part of the 2nd molar tooth.
| Study group | Role | What they receive |
|---|---|---|
| GPN | Experimental | administrated bilateral greater palatine nerve block using levobupivacaine 0.25% Receives: Procedure: peripheral nerve block by 0.25% levobupivacaine |
| SMN | Experimental | administrated bilateral suprazygomatic nerve block using levobupivacaine 0.25%. Receives: Procedure: peripheral nerve block by 0.25% levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score
Pain assessment was done immediately postoperative using Objective behavioral pain score
Measured: the first 12 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Nov 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The two study groups were: * Group GPN, 20 patients received bilateral greater palatine nerve block. * Group SMN, 20 patients received bilateral suprazygomatic maxillary nerve block.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsonbaty, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467463
- Sponsor's protocol ID
- N-98-2019
- Status last verified
- Jun 2020
- First submitted
- 4 Jul 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not to share
Publications
Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available.
PubMed 460932Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. doi: 10.1001/jama.294.8.947.
PubMed 161183853. Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.
Diewert VM. Development of human craniofacial morphology during the late embryonic and early fetal periods. Am J Orthod. 1985 Jul;88(1):64-76. doi: 10.1016/0002-9416(85)90107-1.
PubMed 3860013
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Peripheral Nerve Block Techniques for Perioperative Analgesia During Cleft Palate Surgery in Pediatric Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04467463
- Acronym / sponsor ID
- N-98-2019
- Conditions
- Postoperative Pain
- Keywords
- Suprazygomatic, Maxillary, Palatine, Cleft Palate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Jul 2020 (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.
Regional blocks are commonly used in pediatric anesthesia to achieve adequate postoperative analgesia. Suprazygomatic Maxillary nerve block (SMN) and Greater Palatine nerve block (GPN) are regional blocks described for use during cleft palate (CP) repair surgery.The aim of this study was to compare the analgesic effect as well as the incidence of complications associated with the use of bilateral GPN and bilateral SMN blocks in children undergoing palatoplasty surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The two study groups were: * Group GPN, 20 patients received bilateral greater palatine nerve block. * Group SMN, 20 patients received bilateral suprazygomatic maxillary nerve block.
| Arm | Type | Receives |
|---|---|---|
| GPN | Experimental | Procedure: peripheral nerve block by 0.25% levobupivacaineadministrated bilateral greater palatine nerve block using levobupivacaine 0.25% |
| SMN | Experimental | Procedure: peripheral nerve block by 0.25% levobupivacaineadministrated bilateral suprazygomatic nerve block using levobupivacaine 0.25%. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA I-III scheduled to undergo palatoplasty
Key exclusion criteria (8 listed)
- bleeding disorders,
- skin lesions or wounds at site of proposed needle insertion,
- congenital heart disease,
- respiratory or
- cardiovascular disorders,
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 |
|---|---|---|
| peripheral nerve block by 0.25% levobupivacaineSUBMANDIBULAR nerve block will be performed using a 25G 90 mm beveled needle . the entry point of the needle will be situated at the angle formed by the superior edge of the zygomatic arch below and the posterior orbital rim forward .The needle will be inserted perpendicular to the skin and advanced approximately 20 mm depth to reach the greater wing of the sphenoid deep to the pterygopalatine fossa. Injection of 1ml of 0.25% levobupivacaine will be done over 20 seconds afterensuring negative blood aspiration .greater Palatine Nerve will be blocked bilaterally as it leaves on palatal side through the foramen on the opposite direction of the anterior part of the 3rd molar orthe posterior part of the 2nd molar tooth. | Procedure or surgery | GPN, SMN |
Primary outcome
postoperative pain score
Time frame: the first 12 postoperative hours
Pain assessment was done immediately postoperative using Objective behavioral pain score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Background: PubMed 460932Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available.
- Background: PubMed 16118385Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. doi: 10.1001/jama.294.8.947.
- Background3. Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.
- Background: PubMed 3860013Diewert VM. Development of human craniofacial morphology during the late embryonic and early fetal periods. Am J Orthod. 1985 Jul;88(1):64-76. doi: 10.1016/0002-9416(85)90107-1.
- Individual participant dataSharing planned: No. not to share
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peripheral nerve block by 0.25% levobupivacaine in people with Postoperative Pain, run by Cairo University at 2 sites 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherif Abdullah Mohamed, M.D. (+201002013497 ext. 02, dr.sherif213@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain score (time frame: the first 12 postoperative hours). 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 NCT04467463, which also lists 4 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 29 Oct 2020; AzTrials last refreshed its copy on 27 Oct 2026.