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Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
INFRA ORBITAL BLOCK
Sponsored by
All India Institute of Medical Sciences, Rishikesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AIIMS RishikeshRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group L

Group R

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 19, 2019
Last Updated
December 25, 2019
Sponsor
All India Institute of Medical Sciences, Rishikesh
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1. Study Identification

Unique Protocol Identification Number
NCT04212611
Brief Title
Postoperative Analgesic Effects of Infraorbital Nerve Block in 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 20, 2020 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, Rishikesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group L
Arm Type
Experimental
Arm Description
Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L)
Arm Title
Group R
Arm Type
Experimental
Arm Description
Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% ropivacaine (group R).
Intervention Type
Drug
Intervention Name(s)
INFRA ORBITAL BLOCK
Other Intervention Name(s)
Group L and Group R
Intervention Description
Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) or ropivacaine (group R).
Primary Outcome Measure Information:
Title
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.
Description
Pain is measured using verbal rating scale
Time Frame
Till the second post operative day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AJIT KUMAR, MD
Phone
9910789377
Email
ajitdr.ajit@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijay Adabala, MD
Organizational Affiliation
AIIMS,Rishikesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIIMS Rishikesh
City
Rishikesh
State/Province
Uttarakhand
ZIP/Postal Code
249203
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijay Adabala, MD
Phone
8977335129
Email
vijay.adabala96@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery

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