NCT04212611

Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery

Evaluation of Postoperative Analgesic Effects of Infraorbital Nerve Block by Levobupivacaine vs Ropivacaine After Cleft Palate Surgery: A Double-blinded Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: All India Institute of Medical Sciences, Rishikesh · Other Government
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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

Detailed description

When compared with ropivacaine, levobupivacaine is a newer, safer, longer acting local anesthetic with rapid onset and prolonged duration of analgesia and similar or more pronounced nerve blocking effects, depending on the concentration. Hence the present study is aimed to compare the effectiveness of 0.375% levobupivacaine and 0..375% ropivacaine in infra orbital block for cleft palate surgery.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	INFRA ORBITAL BLOCK	Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) or ropivacaine (group R).

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-01-20
• Completion: 2020-03-01
• First posted: 2019-12-27
• Last updated: 2019-12-27

Locations

1 site across 1 country: India