Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery

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

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

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: INFRA ORBITAL BLOCK

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Uttarakhand
    • Rishikesh, Uttarakhand, India, 249203
      • Recruiting
      • AIIMS Rishikesh
      • Contact: Vijay Adabala, MD; Phone Number: 8977335129; Email: vijay.adabala96@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, Rishikesh
• Investigators: Principal Investigator: Vijay Adabala, MD, AIIMS,Rishikesh

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ANTICIPATED): January 20, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 25, 2019
• First Posted (ACTUAL): December 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 25, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Pain, Postoperative; Cleft Palate
• Other Study ID Numbers: 12 (Israel lung Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: if study comes out with a positive result we will share the data with others
• IPD Sharing Time Frame: one year
• IPD Sharing Access Criteria: website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No