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

NCT ID: NCT06100315

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2026-01-31

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.

Conditions

Complication Following Peripheral Nerve Block

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Bupivacaine

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

No interventions assigned to this group

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).

Nalbuphine

Intervention Type: DRUG

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

Interventions

Nalbuphine

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

Intervention Type: DRUG

Other Intervention Names

Bupivacaine

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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Reem Ayman Mahmoud

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ekram AA Osman, professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Mohamed Fathy Mostafa

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 31888322 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20199610 (View on PubMed)

Other Identifiers

Nalbuphine in nerve block

Identifier Type: -

Identifier Source: org_study_id