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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group L | Experimental | Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) |
|
| Group R | Experimental | Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% ropivacaine (group R). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INFRA ORBITAL BLOCK | Drug | Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) or ropivacaine (group R). |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in the pain score from base line using the verbal rating scale (scale range: 0-5; 0: no pain, 5: strongest pain) on the day of surgery, as well as on the first and second postoperative days. | Pain is measured using verbal rating scale | Till the second post operative day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AJIT KUMAR, MD | Contact | 9910789377 | ajitdr.ajit@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vijay Adabala, MD | AIIMS,Rishikesh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIIMS Rishikesh | Recruiting | Rishikesh | Uttarakhand | 249203 | India |
if study comes out with a positive result we will share the data with others
one year
website
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |