drugset / Trial / NCT04212611

Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery

NCT04212611

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Cleft palate repair is a common surgery in children.. As such children with cleft palate tend to have a compromised airway due to associated congenital anomalies like Pierre Robin syndrome, Treacher Collins syndrome etc. After surgical correction of cleft palate, they are more prone to develop post-operative respiratory difficulty due to narrowed airway, increased secretion, pain and sedation caused by opioids. Hence, regional block, using local anesthetics, becomes a good option in this surgery. The supremacy of bilateral infraorital block using levo bupivacaine over intravenous fentanyl as well as over peri-incisional infiltration in has been shown .Levobupivacaine was developed after Ropivaciane was noted to be associated with less no of adverse events.. Ropivacaine has been used for peripheral block in children for surgical pain. Though the use of Levobupivacaine in regional blocks in facial surgeries has been well established, studies are still needed to establish its supremacy over Ropivacaine in cleft palate surgeries

Timeline

Start
2019-03-01
Primary completion
2020-01-20
Completion
2020-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Levobupivacaine Other / unclassified 0.375 % Other
Subject Ropivacaine Other / unclassified 0.375 % Other

Indications

No indication recorded.