Nalbuphine as Adjuvant During Bilateral Suprazygomatic Maxillary Nerve Block for Pediatric Cleft Palate Repair
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
bupivacaine 0.125% of 0.2 ml/kg and 0.1 mg/kg nalbuphine
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 1 to 7 years.
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Both genders.
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American society of anesthesiologists (ASA) physical state I-II.
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Children undergoing palate surgeries.
Exclusion Criteria:
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Guardians' refusal
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History of developmental delay or mental retardation.
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Children with any co-morbidities.
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Skin infection at the site of injection.
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Bleeding diathesis.
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Known allergy to any drugs used in this study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
- Principal Investigator: Ekram AA Osman, professor, Assiut University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Nalbuphine in nerve block