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

NCT ID: NCT03171090

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-05

Study Completion Date

2018-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Maxillofacial Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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sphenopalatine block using local anasthetic

Group Type ACTIVE_COMPARATOR

sphenopalatine block with saline

Intervention Type OTHER

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

sphenopalatine block using saline

Group Type PLACEBO_COMPARATOR

sphenopalatine block with local anesthetic

Intervention Type OTHER

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

Interventions

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sphenopalatine block with local anesthetic

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

Intervention Type OTHER

sphenopalatine block with saline

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed H Othman

Associte professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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NCI, Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IORG0003381

Identifier Type: -

Identifier Source: org_study_id

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