Complication Following Peripheral Nerve BlockPhase 2/3NCT06100315
Nalbuphine as Adjuvant During Bilateral Suprazygomatic Maxillary Nerve Block for Pediatric Cleft Palate Repair
A Phase 2/3 study testing Nalbuphine and Bupivacaine in people with Complication Following Peripheral Nerve Block, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy of adding nalbuphine to bupivacaine via suprazygomatic nerve block for postoperative pain control and emergence agitation management in pediatrics aged from to 1 to 7 years who were maintained on sevoflurane inhalational anesthesia and scheduled for cleft lip and… Read more about this study
- Who is it for?
- Ages 12 months to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Complication Following Peripheral Nerve Block
- What is being tested?
- Nalbuphine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jul 2023to 31 Jan 2026
- 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 12 months to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 1 to 7 years.
- Both genders.
- American society of anesthesiologists (ASA) physical state I-II.
- Children undergoing palate surgeries.
Who cannot join
- Guardians' refusal
- History of developmental delay or mental retardation.
- Children with any co-morbidities.
- Skin infection at the site of injection.
- Bleeding diathesis.
- Known allergy to any drugs used in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nalbuphine as Adjuvant During Bilateral Suprazygomatic Maxillary Nerve Block for Pediatric Cleft Palate Repair: A Prospective, Randomized Comparative, Controlled Double-blind Study.
The aim of this study is to evaluate the efficacy of adding nalbuphine to bupivacaine via suprazygomatic nerve block for postoperative pain control and emergence agitation management in pediatrics aged from to 1 to 7 years who were maintained on sevoflurane inhalational anesthesia and scheduled for cleft lip and palate operation.
Read the detailed description
Cleft lip and cleft palate are the most common craniofacial abnormalities in children. Cleft surgery results in a profound sympathetic stimulation leading to hypertension, tachycardia, and bleeding. Postoperative pain can be severe, and many of these patients are at increased risk of opioid-induced respiratory depression. Emergence agitation (EA) is another common problem in these children, with an incidence between 10% and 80% after sevoflurane anesthesia. Inadequate postoperative analgesia combined with vigorous crying may lead to surgical complications including wound dehiscence, bleeding, and respiratory compromise. The anesthetic management of cleft surgery should ideally bound the intraoperative autonomic response and provide adequate analgesia without respiratory depression or EA. A combination of inhalation-based anesthesia and high-dose opioids has been described to block the autonomic response during surgical dissection; however, this technique may be associated with postoperative sedation and respiratory depression. Surgical infiltration with a local anesthetic and a vasoconstrictor promotes hemostasis and reduces the autonomic response intraoperatively but does not provide extended postoperative pain relief. Sensory innervation of the lip and palate is provided by branches of the maxillary nerve. Suprazygomatic maxillary nerve blocks have been shown to be opioid-sparing after cleft lip and palate surgery. The addition of opioid analgesic might both prolong the analgesia after a regional nerve block and reduce the incidence of EA.
- Being tested
- Nalbuphine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
Also called Bupivacaine
bupivacaine 0.125% of 0.2 ml/kg and 0.1 mg/kg nalbuphine
BupivacaineDrug
30 patients received SMB using bupivacaine 0.125% of 0.2 ml/kg on each side (with maximum volume of 4 ml).
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | 30 patients received SMB using bupivacaine 0.125% of 0.2 ml/kg on each side (with maximum volume of 4 ml). Receives: Drug: Bupivacaine |
| Bupivacaine and Nalbuphine | Active comparator | 30 patients received SMB using bupivacaine 0.125 of 0.2 ml/kg + 0.1 mg/kg nalbuphine on each side (with maximum volume of 4 ml). Receives: Drug: Nalbuphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain control
Postoperative pain will be assessed by FLACC which is (Face,Legs,Activity,Cry,Consolability) score in the first postoperative day.The scale is scored in the range of 0 - 10 with 0 representing no pain.10 representing severe pain. The scale has five criteria which are each assigned a score of 0, 1 or 2.
Measured: first day postoperative
Secondary outcomes (3)
Effect of nalbuphine with maxillary nerve block on postoperative emergence agitation according to WATCHA Scale "emergancy delirium scale"
The WATCHA scale is a four level arousal scale ranging from a "calm" patient (Score of 1) to "agitation with thrashing around" (Score of 4),"crying but can be consoled" is (Score of 2), "crying but cannot be consoled" is (Score of 3)
Measured: first day postoperative
Asses the time for rescue analgesia
time to first dose of rescue analgesia, total amount of rescue analgesia in first 24 h postoperatively.
Measured: first day postoperative
Asses the parents satisfaction
Participants' satisfaction after the end of procedure the through 5-point Likert scale which is parent satisfaction score. (1 = very satisfied and willing to take the same medication and procedure in the future when indicated, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5 = very dissatisfied).
Measured: first day postoprrative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start31 Jul 2023
- Primary completion31 Oct 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complication Following Peripheral Nerve BlockStudies 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, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Ayman Mahmoud, Assiut University
- Investigators
- Ekram AA Osman, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100315
- Sponsor's protocol ID
- Nalbuphine in nerve block
- Status last verified
- Jan 2026
- First submitted
- 14 Oct 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mostafa MF, Aal FAA, Ali IH, Ibrahim AK, Herdan R. Dexmedetomidine during suprazygomatic maxillary nerve block for pediatric cleft palate repair, randomized double-blind controlled study. Korean J Pain. 2020 Jan 1;33(1):81-89. doi: 10.3344/kjp.2020.33.1.81.
PubMed 31888322Mesnil M, Dadure C, Captier G, Raux O, Rochette A, Canaud N, Sauter M, Capdevila X. A new approach for peri-operative analgesia of cleft palate repair in infants: the bilateral suprazygomatic maxillary nerve block. Paediatr Anaesth. 2010 Apr;20(4):343-9. doi: 10.1111/j.1460-9592.2010.03262.x. Epub 2010 Feb 23.
PubMed 20199610
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nalbuphine as Adjuvant During Bilateral Suprazygomatic Maxillary Nerve Block for Pediatric Cleft Palate Repair: A Prospective, Randomized Comparative, Controlled Double-blind Study.
- ClinicalTrials.gov ID
- NCT06100315
- Acronym / sponsor ID
- Nalbuphine in nerve block
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 25 Oct 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.
The aim of this study is to evaluate the efficacy of adding nalbuphine to bupivacaine via suprazygomatic nerve block for postoperative pain control and emergence agitation management in pediatrics aged from to 1 to 7 years who were maintained on sevoflurane inhalational anesthesia and scheduled for cleft lip and palate operation.
Detailed description
Cleft lip and cleft palate are the most common craniofacial abnormalities in children. Cleft surgery results in a profound sympathetic stimulation leading to hypertension, tachycardia, and bleeding. Postoperative pain can be severe, and many of these patients are at increased risk of opioid-induced respiratory depression. Emergence agitation (EA) is another common problem in these children, with an incidence between 10% and 80% after sevoflurane anesthesia. Inadequate postoperative analgesia combined with vigorous crying may lead to surgical complications including wound dehiscence, bleeding, and respiratory compromise. The anesthetic management of cleft surgery should ideally bound the intraoperative autonomic response and provide adequate analgesia without respiratory depression or EA. A combination of inhalation-based anesthesia and high-dose opioids has been described to block the autonomic response during surgical dissection; however, this technique may be associated with postoperative sedation and respiratory depression. Surgical infiltration with a local anesthetic and a vasoconstrictor promotes hemostasis and reduces the autonomic response intraoperatively but does not provide extended postoperative pain relief. Sensory innervation of the lip and palate is provided by branches of the maxillary nerve. Suprazygomatic maxillary nerve blocks have been shown to be opioid-sparing after cleft lip and palate surgery. The addition of opioid analgesic might both prolong the analgesia after a regional nerve block and reduce the incidence of EA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: Bupivacaine30 patients received SMB using bupivacaine 0.125% of 0.2 ml/kg on each side (with maximum volume of 4 ml). |
| Bupivacaine and Nalbuphine | Active comparator | Drug: Nalbuphine30 patients received SMB using bupivacaine 0.125 of 0.2 ml/kg + 0.1 mg/kg nalbuphine on each side (with maximum volume of 4 ml). |
Who may qualify
- Ages
- 12 months to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 1 to 7 years.
- Both genders.
- American society of anesthesiologists (ASA) physical state I-II.
- Children undergoing palate surgeries.
Key exclusion criteria (6 listed)
- Guardians' refusal
- History of developmental delay or mental retardation.
- Children with any co-morbidities.
- Skin infection at the site of injection.
- Bleeding diathesis.
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 |
|---|---|---|
| NalbuphineAlso: Bupivacainebupivacaine 0.125% of 0.2 ml/kg and 0.1 mg/kg nalbuphine | Drug | Bupivacaine and Nalbuphine |
| Bupivacaine30 patients received SMB using bupivacaine 0.125% of 0.2 ml/kg on each side (with maximum volume of 4 ml). | Drug | Bupivacaine |
Primary outcome
pain control
Time frame: first day postoperative
Postoperative pain will be assessed by FLACC which is (Face,Legs,Activity,Cry,Consolability) score in the first postoperative day.The scale is scored in the range of 0 - 10 with 0 representing no pain.10 representing severe pain. The scale has five criteria which are each assigned a score of 0, 1 or 2.
3 secondary outcomes
Effect of nalbuphine with maxillary nerve block on postoperative emergence agitation according to WATCHA Scale "emergancy delirium scale"
Time frame: first day postoperative
Asses the time for rescue analgesia
Time frame: first day postoperative
Asses the parents satisfaction
Time frame: first day postoprrative
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 1 Sep 2026.
- Results publication: PubMed 31888322Mostafa MF, Aal FAA, Ali IH, Ibrahim AK, Herdan R. Dexmedetomidine during suprazygomatic maxillary nerve block for pediatric cleft palate repair, randomized double-blind controlled study. Korean J Pain. 2020 Jan 1;33(1):81-89. doi: 10.3344/kjp.2020.33.1.81.
- Results publication: PubMed 20199610Mesnil M, Dadure C, Captier G, Raux O, Rochette A, Canaud N, Sauter M, Capdevila X. A new approach for peri-operative analgesia of cleft palate repair in infants: the bilateral suprazygomatic maxillary nerve block. Paediatr Anaesth. 2010 Apr;20(4):343-9. doi: 10.1111/j.1460-9592.2010.03262.x. Epub 2010 Feb 23.
- Individual participant dataSharing planned: Undecided
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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.
Ekram AA Osman, professor principal investigator
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 Nalbuphine and Bupivacaine in people with Complication Following Peripheral Nerve Block, 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 6 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 1 Sep 2026. 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?
pain control (time frame: first day postoperative). 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 NCT06100315, which also lists 2 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 1 Sep 2026.