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A Randomized Clinical Study on Bilateral Suprazygomatic Maxillary Nerve Block in Comparison with Bilateral Palatine Nerve Block for The Control of Immediate Post-Operative Pain Following Palatorrhaphy

A Randomized Clinical Study on Bilateral Suprazygomatic Maxillary Nerve Block in Comparison with Bilateral Palatine Nerve Block for The Control of Immediate Post-Operative Pain Following Palatorrhaphy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202602832389116
Enrollment
52
Registered
2026-02-23
Start date
2024-06-19
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health Surgery

Interventions

Bilateral Suprazygomatic Maxillary nerve block
Palatine Nerve Block

Sponsors

Research Grant
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: inclusion criteria. Inclusion criteria would include 1. All patients with non-syndromic unilateral cleft palate with or without cleft lip. 2. All patients with non-syndromic bilateral cleft palate with or without cleft lip. 3. All patients with cleft palate only. 4. Patients scheduled for secondary palatorraphy. 5. Children with cleft lip and palate between the age of 12 months to 5 years. 6. Patients certified fit for cleft palate repair by the anaesthesiologists with American Society of Anaesthiologists (ASA) I-II 7. All guardians who consent for their wards to be included in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with a medical history suggestive of allergy to bupivacaine. 2. Patients with the presence of coagulation disorders, peripheral neuropathy or chronic pain syndrome, local infection or presence of a lesion or neoplasm around the injection site, chronic rhinorrhea with acute exacerbation and obstructive upper airway disease. 3. Patients with systemic disease that compromises the cardiovascular, respiratory, or neurological function as well as other congenital anomalies. 4. Patients with atypical facial clefts and syndromic clefts. 5. Patients scheduled for palatal fistula repair. 6. Patients whose parents/guardians do not consent to participate in the study.

Design outcomes

Primary

MeasureTime frame
The duration of analgesia will be assessed following the administration of the suprazygomatic maxillary nerve block in the experimental group and palatine nerve block in the control group using Faces, Legs, Activity, Crying and Consolability pain assessment tool- FLACC pain assessment tool. Pain scores higher than 3 would be assessed as moderate pain and would mark the end of the duration of the analgesia.;The quality of pain control would be assessed following the administration of the suprazygomatic maxillary nerve block in the experimental group and the palatine nerve block in the control block using the FLACC pain assessment tool. Score 0 being no pain and scores 1-3 being mild pain scores.

Secondary

MeasureTime frame
The duration of the administration of analgesia in both groups would be assessed using a timer to assess how long it takes to administer the analgesia in both groups

Countries

Nigeria

Contacts

Public ContactRacheal Babayomi

Senior Registrar Oral and Maxillofacial Surgery

racheal.zion@gmail.com+2348063248836

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026