Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Drug: INFRA ORBITAL BLOCK

• Registration Number: NCT04212611
• Lead Sponsor: All India Institute of Medical Sciences, Rishikesh

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.

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-25
• Last Update Submitted: 2019-12-25
• Study First Posted: 2019-12-27
• Last Update Posted: 2019-12-27
• Primary Completion: 2020-01-20
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L	INFRA ORBITAL BLOCK	Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L)
Group R	INFRA ORBITAL BLOCK	Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% ropivacaine (group R).

Primary Outcome Measures

Name	Time	Method
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.	Till the second post operative day.	Pain is measured using verbal rating scale

Trial Locations

Locations (1)

AIIMS Rishikesh; 🇮🇳 Rishikesh, Uttarakhand, India