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

Active, not recruiting

• Conditions: Complication Following Peripheral Nerve Block
• Interventions: Drug: Nalbuphine

• Registration Number: NCT06100315
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2023-07-31
• Study First Submitted: 2023-10-14
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bupivacaine and Nalbuphine	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).

Primary Outcome Measures

Name	Time	Method
pain control	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.

Secondary Outcome Measures

Name	Time	Method
Effect of nalbuphine with maxillary nerve block on postoperative emergence agitation according to WATCHA Scale "emergancy delirium scale"	first day postoperative	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)
Asses the time for rescue analgesia	first day postoperative	time to first dose of rescue analgesia, total amount of rescue analgesia in first 24 h postoperatively.
Asses the parents satisfaction	first day postoprrative	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).

Trial Locations

Locations (1)

Mohamed Fathy Mostafa; 🇪🇬 Assiut, Egypt