Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery

NCT04212611 | Unknown

• 1 other identifier: 12
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Group L

EXPERIMENTAL

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

Drug: INFRA ORBITAL BLOCK

Group R

EXPERIMENTAL

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

Drug: INFRA ORBITAL BLOCK

Interventions

INFRA ORBITAL BLOCK DRUG

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

Also known as: Group L and Group R

Group L; Group R

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Patient's refusal
• Allergy to the amide group of local anaesthetic agent
• Patient on anticoagulants or bleeding disorder
• Underlying other significant systemic diseases.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Rishikesh: lead

Study Sites (1)

AIIMS Rishikesh

Rishikesh, Uttarakhand, 249203, India

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Vijay Adabala, MD

  AIIMS,Rishikesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AJIT KUMAR, MD

CONTACT

9910789377; ajitdr.ajit@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 27, 2019
• Study Start: March 1, 2019
• Primary Completion: January 20, 2020
• Study Completion: March 1, 2020
• Last Updated: December 27, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: one year
• Access Criteria: website

Locations

IN (1)