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Status unknownNCT04467463Updated Oct 29, 2020

Peripheral Nerve Block Techniques During Cleft Palate

An interventional study of peripheral nerve block by 0.25% levobupivacaine in Postoperative Pain, sponsored by Cairo University. Status unknown at 2 sites in Egypt. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2020-10-29.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
6 Months to 5 Years
Sex
All
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Study summary

Regional blocks are commonly used in pediatric anesthesia to achieve adequate postoperative analgesia. Suprazygomatic Maxillary nerve block (SMN) and Greater Palatine nerve block (GPN) are regional blocks described for use during cleft palate (CP) repair surgery.The aim of this study was to compare the analgesic effect as well as the incidence of complications associated with the use of bilateral GPN and bilateral SMN blocks in children undergoing palatoplasty surgery.

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Conditions studied

  • Postoperative Pain

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Keywords

  • Suprazygomatic
  • Maxillary
  • Palatine
  • Cleft Palate
03

In context

Cleft Palate

131 studies on the registry are indexed under Cleft Palate; 36 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 85 interventional studies indexed under Cleft Palate.

Browse Cleft Palate studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA I-III scheduled to undergo palatoplasty

Exclusion criteria

Exclusion Criteria:

  • bleeding disorders,
  • skin lesions or wounds at site of proposed needle insertion,
  • congenital heart disease,
  • respiratory or
  • cardiovascular disorders,
  • children scheduled for combined procedures like palatoplasty with cheiloplasty or submucosal alveolar bone grafting,
  • known hypersensitivity to local anesthetics or opioids and
  • lack of parental consent.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    GPN

    administrated bilateral greater palatine nerve block using levobupivacaine 0.25%

    Procedure: peripheral nerve block by 0.25% levobupivacaine

  • Experimental
    SMN

    administrated bilateral suprazygomatic nerve block using levobupivacaine 0.25%.

    Procedure: peripheral nerve block by 0.25% levobupivacaine

Interventions

  • Procedureperipheral nerve block by 0.25% levobupivacaine

    SUBMANDIBULAR nerve block will be performed using a 25G 90 mm beveled needle . the entry point of the needle will be situated at the angle formed by the superior edge of the zygomatic arch below and the posterior orbital rim forward .The needle will be inserted perpendicular to the skin and advanced approximately 20 mm depth to reach the greater wing of the sphenoid deep to the pterygopalatine fossa. Injection of 1ml of 0.25% levobupivacaine will be done over 20 seconds afterensuring negative blood aspiration .greater Palatine Nerve will be blocked bilaterally as it leaves on palatal side through the foramen on the opposite direction of the anterior part of the 3rd molar orthe posterior part of the 2nd molar tooth.

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What researchers measure

Primary outcomes

  1. postoperative pain score

    Pain assessment was done immediately postoperative using Objective behavioral pain score

    Time frame: the first 12 postoperative hours

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Study locations

1 of 2 sites recruiting
  • Cairo University hospitals
    Cairo, Manial 12511, Egypt
    Recruiting
  • anesthesia department at Cairo University
    Cairo, Egypt
    Completed
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References and documents

Publications

  • Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available. PubMed 460932 ↗
  • Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. doi: 10.1001/jama.294.8.947. PubMed 16118385 ↗
  • 3. Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.
  • Diewert VM. Development of human craniofacial morphology during the late embryonic and early fetal periods. Am J Orthod. 1985 Jul;88(1):64-76. doi: 10.1016/0002-9416(85)90107-1. PubMed 3860013 ↗

Individual participant data

Plan to share: No — not to share

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04467463
Lead sponsor
Cairo University
Responsible party
Mohamed Elsonbaty (Principal Investigator, Cairo University) — Principal investigator
First posted
Jul 13, 2020
Start date
Nov 1, 2020 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Oct 29, 2020

Study contacts

Sherif Abdullah Mohamed, M.D.
Contact
dr.sherif213@yahoo.com
+201002013497 ext. 02

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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