Clinical trial NCT06100315: Nalbuphine as Adjuvant During Bilateral Suprazygomatic Maxillary Nerve Block for Pediatric Cleft Palate Repair
Official title: Nalbuphine as Adjuvant During Bilateral Suprazygomatic Maxillary Nerve Block for Pediatric Cleft Palate Repair: A Prospective, Randomized Comparative, Controlled Double-blind Study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Complication Following Peripheral Nerve Block
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample size calculation was carried out using G\*Power 3 software. A calculated minimum sample of 54 pediatric patients will be needed and further randomly assigned into one of two equal groups (Group N - Nalbuphine group): 27 patients and Group B - Control arm): 27 patients, to detect an effect size of 0.5 in the mean value of postoperative pain control and emergence agitation management with an error probability of 0.05 and 80% power on a two-tailed test. But to avoid possible loss of samples (dropouts) during the study, the number of patients in each group will be increased to 30 to be a total of 60 patients.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Age 1 to 7 years.
2. Both genders.
3. American society of anesthesiologists (ASA) physical state I-II.
4. Children undergoing palate surgeries.

Exclusion Criteria:

1. Guardians' refusal
2. History of developmental delay or mental retardation.
3. Children with any co-morbidities.
4. Skin infection at the site of injection.
5. Bleeding diathesis.
6. Known allergy to any drugs used in this study.

Primary outcomes:
measure: pain control
timeFrame: first day postoperative
Secondary outcomes:
measure: Effect of nalbuphine with maxillary nerve block on postoperative emergence agitation according to WATCHA Scale "emergancy delirium scale"
timeFrame: first day postoperative
measure: Asses the time for rescue analgesia
timeFrame: first day postoperative
measure: Asses the parents satisfaction
timeFrame: first day postoprrative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Mohamed Fathy Mostafa
Study officials:
affiliation: Assiut University
name: Ekram AA Osman, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Mesnil 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.