Suprazygomatic Nerve Block vs Surgical Site Infiltration in Cleft Palate Repair

NCT03799068 | Unknown

• 1 other identifier: Cleft Palate
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy and duration of effect of bupivacaine given preoperatively as a bilateral suprazygomatic maxillary nerve block and to compare it with peri-incisional infiltration with the same agent for perioperative analgesia in children undergoing cleft palate repair.

Conditions

Cleft Palate Children; Block

Keywords

bupivacaine; suprazygomatic nerve block

Outcome Measures

Primary Outcomes (1)

• Pain assessment

  By Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) in Young Children (1-7 years) is a behavioral scale for evaluating postoperative pain in young children. Cry No crying +1 Moaning,crying +2 Screaming+3 Facial expression: Smiling +1 Composed, neutral +2 Grimace +3 Verbal responses Positive statements +1 Negative statement +2 Suffering from pain +3 Torso Neutral/resting +1 Shifting, shivering, upright +2 Restrained +3 Legs Neutral position+1 Squirming/kicking, drawn up, tensed legs +2 Restrained +3 Cheops score of 4 or less indicates no pain. Rescue analgesic consisting of paracetamol 10-15 mg/kg will be given rectally when CHEOPS is \> 4.

  24 hours postoperative

Study Arms (2)

suprazygomatic maxillary nerve block

ACTIVE COMPARATOR

the group were given a bilateral suprazygomatic maxillary nerve block with 0.125% bupivacaine, 2 ml on each side, the total dose of bupivacaine not exceeding 2 mg/kg.

Other: suprazygomatic maxillary nerve block

surgical site infiltraion

ACTIVE COMPARATOR

the group were given peri-incisional infiltration with 0.125% bupivacaine, 2 ml on each side. In all cases the block was given by the anaesthetist and the infiltration by the surgeon.

Other: surgical site infiltration

Interventions

suprazygomatic maxillary nerve block OTHER

bilateral Suprazygomatic maxillary nerve block is performed before surgery in anaesthetized children, after aseptic preparation of the skin. The patient is in supine position with the head in neutral position. The puncture site is at the frontozygomatic angle, at the junction of the upper edge of the zygomatic arch and the frontal process. A 24G needle is attached to a syringe containing the local anaesthetic. It is advanced to reach the greater wing of sphenoid at approximately 20 mm depth, then withdrawn a few millimetres and redirected toward the nasolabial fold in a 20° forward and 10° downward direction. The progression in the pterygopalatine fossa is 35 to 45 mm. Loss of resistance after passing through the temporalis muscle assisted in determining the puncture depth. After a negative blood aspiration test, the calculated dose of the local anaesthetic is injected on each side.

suprazygomatic maxillary nerve block

surgical site infiltration OTHER

peri-incisional infiltration of bupivacaine around the incision site given by the surgeon on an anesthetized patient before the incision is done.

surgical site infiltraion

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA grade I-III.
• Aged from1-5 years
• Undergoing cleft palate repair.

You may not qualify if:

• Patient's refusal.
• Allergy to local anaesthetics.
• Trigeminal neuralgia.
• Bleeding diathesis.
• Inflammation or infection over injection site.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical physician

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: January 10, 2019
• Study Start: October 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2019
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)