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Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery

NCT04212611 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-12-27

No results posted yet for this study

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

Conditions

  • Pain, Postoperative

Interventions

DRUG

INFRA ORBITAL BLOCK

Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) or ropivacaine (group R).

Sponsors & Collaborators

  • All India Institute of Medical Sciences, Rishikesh

    lead OTHER_GOV

Principal Investigators

  • Vijay Adabala, MD · AIIMS,Rishikesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04212611 on ClinicalTrials.gov