Back to resultsEfficacy of Bilateral Ultrasonic Guided Sphenopalatine Ganglion Block in Maxilofacial Cancer Surgeries
Primary Purpose
Maxillofacial Tumors
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sphenopalatine block with local anesthetic
sphenopalatine block with saline
Sponsored by
About this trial
This is an interventional treatment trial for Maxillofacial Tumors
Eligibility Criteria
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
Sites / Locations
- NCI, Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
sphenopalatine block using local anasthetic
sphenopalatine block using saline
Arm Description
Outcomes
Primary Outcome Measures
Post - operative analgesia
according to VAS measured in the postoperative period
Secondary Outcome Measures
total dose of analgesic consumption
total nalufen dose
number of patients required analgesia
number of patients required nalufen
Full Information
NCT ID
NCT03171090
First Posted
May 25, 2017
Last Updated
October 27, 2019
Sponsor
Assiut University
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT03171090
Brief Title
Efficacy of Bilateral Ultrasonic Guided Sphenopalatine Ganglion Block in Maxilofacial Cancer Surgeries
Official Title
Efficacy of Bilaterally Ultrasonic Guided Sphenopalatine Ganglion Block for Perioperative Pain Management in Maxilofacial Cancer Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
March 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
Collaborators
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillofacial Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sphenopalatine block using local anasthetic
Arm Type
Active Comparator
Arm Title
sphenopalatine block using saline
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
sphenopalatine block with local anesthetic
Intervention Description
bilateral ultrasonic guided sphenopalatine ganglion block using local anesthetic after induction of general anesthesia in maxilofacial cancer surgeries
Intervention Type
Other
Intervention Name(s)
sphenopalatine block with saline
Intervention Description
bilateral ultrasonic guided sphenopalatine ganglion block using saline after induction of general anesthesia in maxilofacial cancer surgeries
Primary Outcome Measure Information:
Title
Post - operative analgesia
Description
according to VAS measured in the postoperative period
Time Frame
24 hours postopeatively
Secondary Outcome Measure Information:
Title
total dose of analgesic consumption
Description
total nalufen dose
Time Frame
24 hours
Title
number of patients required analgesia
Description
number of patients required nalufen
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
NCI, Cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Bilateral Ultrasonic Guided Sphenopalatine Ganglion Block in Maxilofacial Cancer Surgeries
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