Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: INFRA ORBITAL BLOCK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children in the age of 2-12 years Children undergoing elective surgery for cleft palate. Children who are conscious and willing to participate in the study. Children who speak and understand English, Hindi, local or others. Exclusion Criteria: Patient's refusal Allergy to the amide group of local anaesthetic agent Patient on anticoagulants or bleeding disorder Underlying other significant systemic diseases.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group L<br>Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) | Drug: INFRA ORBITAL BLOCK<br>* Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) or ropivacaine (group R).<br>* Other names: Group L and Group R;|
| Experimental: Group R<br>Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% ropivacaine (group R). | Drug: INFRA ORBITAL BLOCK<br>* Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) or ropivacaine (group R).<br>* Other names: Group L and Group R;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. |