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Suprazygomatic Nerve Block vs Surgical Site Infiltration in Cleft Palate Repair

NCT03799068 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-01-10

No results posted yet for this study

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

Interventions

OTHER

suprazygomatic maxillary nerve block

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 It is advanced to reach the greater wing of sphenoid at approximately 20 mm depth, then withdrawn a few millimetres and redirected toward the nasolabial fold in a 20° forward and 10° downward direction.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.

OTHER

surgical site infiltration

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-03-31
Completion
2019-05-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03799068 on ClinicalTrials.gov