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CompletedNCT03171090Updated Oct 29, 2019

Efficacy of Bilateral Ultrasonic Guided Sphenopalatine Ganglion Block in Maxilofacial Cancer Surgeries

An interventional study of sphenopalatine block with local anesthetic and sphenopalatine block with saline in Maxillofacial Tumors, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-10-29.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

Patients will be randomly allocated according to computer - generated tables to one of two groups, group (A) ultrasonic guided sphenopalatine block using local anasthetic, group (B) ultrasonic guided sphenopalatine block using saline. Before induction anesthesia the following will be assessed, time needed to perform the technique, time till onset of the block, distribution of the block (Opthalmic, Maxillary, Mandibular) by needle brick.Intra and post- operatively the following will be assesse the quality of operative filed every 30 min intra-operatively using a pre- defined average category scale (ACS) (from 0 to 5), End tidal Sevo Flurane concentration will be recorded intra- operatively every 5 minutes, The total amount of Nitroglycerine used to achieve the target MAP and frequency of propranolol usage will be recorded,emergence time, postoperative VAS score and amount of meperdine used for rescue analgesia.

02

Conditions studied

  • Maxillofacial Tumors

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03

In context

Ganglion Cysts

136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.

This study's enrollment of 48 is below the median of 60 across 101 interventional studies indexed under Ganglion Cysts.

Browse Ganglion Cysts studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults patients of ASA physical status I and II, aged 20-70 year who will be scaduled for Maxillo - facial cancer surgeries

Exclusion criteria

Exclusion Criteria:

  • patients with disfigurement and disturbed anatomy that will not allow easy access to the sphenopalatine ganglion, bleeding disorders, history of hepatic, renal or cardiopulmonary dysfunction, patients receiving drugs affecting coagulation or cardiovascular active medication are excluded also patients having infection or allergies to local anesthetics
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    sphenopalatine block using local anasthetic

    Other: sphenopalatine block with saline

  • Placebo comparator
    sphenopalatine block using saline

    Other: sphenopalatine block with local anesthetic

Interventions

  • Othersphenopalatine block with local anesthetic

    bilateral ultrasonic guided sphenopalatine ganglion block using local anesthetic after induction of general anesthesia in maxilofacial cancer surgeries

  • Othersphenopalatine block with saline

    bilateral ultrasonic guided sphenopalatine ganglion block using saline after induction of general anesthesia in maxilofacial cancer surgeries

06

What researchers measure

Primary outcomes

  1. Post - operative analgesia

    according to VAS measured in the postoperative period

    Time frame: 24 hours postopeatively

Secondary outcomes

  1. total dose of analgesic consumption

    total nalufen dose

    Time frame: 24 hours

  2. number of patients required analgesia

    number of patients required nalufen

    Time frame: 24 hours

07

Study locations

1 site
  • NCI, Cairo university
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03171090
Lead sponsor
Assiut University
Collaborators
Cairo University
Responsible party
Ahmed H Othman (Associte professor, Assiut University) — Principal investigator
First posted
May 31, 2017
Start date
Jun 5, 2017
Primary completion
Oct 1, 2017
Completion
Mar 15, 2018
Last update
Oct 29, 2019

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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