Nalbuphine as Adjuvant During Bilateral Suprazygomatic Maxillary Nerve Block for Pediatric Cleft Palate Repair

NCT06100315 | Active Not Recruiting

• 1 other identifier: Nalbuphine in nerve block
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication Following Peripheral Nerve Block

Outcome Measures

Primary Outcomes (1)

• 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.

  first day postoperative

Secondary Outcomes (3)

• Effect of nalbuphine with maxillary nerve block on postoperative emergence agitation according to WATCHA Scale "emergancy delirium scale"

  first day postoperative

• Asses the time for rescue analgesia

  first day postoperative

• Asses the parents satisfaction

  first day postoprrative

Study Arms (2)

Bupivacaine

30 patients will receive SMB using bupivacaine 0.125% of 0.2 ml/kg on each side (with maximum volume of 4 ml).

Bupivacaine and Nalbuphine

30 patients will receive SMB using bupivacaine 0.125 of 0.2 ml/kg + 0.1 mg/kg nalbuphine on each side (with maximum volume of 4 ml).

Drug: Nalbuphine

Interventions

Nalbuphine DRUG

bupivacaine 0.125% of 0.2 ml/kg and 0.1 mg/kg nalbuphine

Also known as: Bupivacaine

Bupivacaine and Nalbuphine

Eligibility Criteria

• Age: 12 Months - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Mohamed Fathy Mostafa

Asyut, Egypt

Location

Related Publications (2)

• 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.

  PMID: 31888322 RESULT

• 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.

  PMID: 20199610 RESULT

MeSH Terms

Interventions

Nalbuphine; Bupivacaine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ekram AA Osman, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: October 25, 2023
• Study Start: July 31, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

EG (1)