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

Assiut University

Status: Active, not recruiting

Conditions: Complication Following Peripheral Nerve Block

Treatments: Drug: Nalbuphine

Study type: Observational

Funder types: Other

Identifiers

NCT06100315

Nalbuphine in nerve block

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 12 months to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Bupivacaine

Description:

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

Description:

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).

Treatment:

Drug: Nalbuphine