Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212611
• Other study ID #: 12
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: December 2019
• Source: All India Institute of Medical Sciences, Rishikesh
• Contact: AJIT KUMAR, MD
• Phone: 9910789377
• Email: ajitdr.ajit[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 1, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Palate
• Pain, Postoperative

Intervention

Drug:
• INFRA ORBITAL BLOCK
Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) or ropivacaine (group R).

Locations

Country	Name	City	State
India	AIIMS Rishikesh	Rishikesh	Uttarakhand

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, Rishikesh

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.