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Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery

NCT ID: NCT04212611

Last Updated: 2019-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-03-01

Brief Summary

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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

Detailed Description

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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

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group L

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

Group Type EXPERIMENTAL

INFRA ORBITAL BLOCK

Intervention Type DRUG

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

Group R

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

Group Type EXPERIMENTAL

INFRA ORBITAL BLOCK

Intervention Type DRUG

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

Interventions

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INFRA ORBITAL BLOCK

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

Intervention Type DRUG

Other Intervention Names

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Group L and Group R

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences, Rishikesh

OTHER_GOV

Sponsor Role lead

Responsible Party

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ADABALA VIJAY BABU

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vijay Adabala, MD

Role: PRINCIPAL_INVESTIGATOR

AIIMS,Rishikesh

Locations

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AIIMS Rishikesh

Rishikesh, Uttarakhand, India

Site Status RECRUITING

Countries

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India

Central Contacts

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AJIT KUMAR, MD

Role: CONTACT

Phone: 9910789377

Email: [email protected]

Facility Contacts

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Vijay Adabala, MD

Role: primary

Other Identifiers

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12

Identifier Type: -

Identifier Source: org_study_id