Maxillofacial TumorsNCT03171090
Efficacy of Bilateral Ultrasonic Guided Sphenopalatine Ganglion Block in Maxilofacial Cancer Surgeries
A study testing sphenopalatine block with local anesthetic and sphenopalatine block with saline in people with Maxillofacial Tumors, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Maxillofacial Tumors
- What is being tested?
- sphenopalatine block with local anesthetic and sphenopalatine block with saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2017to 15 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults patients of ASA physical status I and II, aged 20-70 year who will be scaduled for Maxillo - facial cancer surgeries
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Bilaterally Ultrasonic Guided Sphenopalatine Ganglion Block for Perioperative Pain Management in Maxilofacial Cancer Surgeries
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.
- Conditions
- Maxillofacial Tumors
- Being tested
- sphenopalatine block with local anesthetic, sphenopalatine block with saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sphenopalatine block with local anestheticOther
bilateral ultrasonic guided sphenopalatine ganglion block using local anesthetic after induction of general anesthesia in maxilofacial cancer surgeries
sphenopalatine block with salineOther
bilateral ultrasonic guided sphenopalatine ganglion block using saline after induction of general anesthesia in maxilofacial cancer surgeries
| Study group | Role | What they receive |
|---|---|---|
| sphenopalatine block using local anasthetic | Active comparator | Not described Receives: Other: sphenopalatine block with saline |
| sphenopalatine block using saline | Placebo comparator | Not described Receives: Other: sphenopalatine block with local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post - operative analgesia
according to VAS measured in the postoperative period
Measured: 24 hours postopeatively
Secondary outcomes (2)
total dose of analgesic consumption
total nalufen dose
Measured: 24 hours
number of patients required analgesia
number of patients required nalufen
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start5 Jun 2017
- Primary completion1 Oct 2017
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial TumorsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Ahmed H Othman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171090
- Sponsor's protocol ID
- IORG0003381
- Status last verified
- Oct 2019
- First submitted
- 25 May 2017
- Last updated
- 29 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bilaterally Ultrasonic Guided Sphenopalatine Ganglion Block for Perioperative Pain Management in Maxilofacial Cancer Surgeries
- ClinicalTrials.gov ID
- NCT03171090
- Acronym / sponsor ID
- IORG0003381
- Conditions
- Maxillofacial Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sphenopalatine block using local anasthetic | Active comparator | Other: sphenopalatine block with saline |
| sphenopalatine block using saline | Placebo comparator | Other: sphenopalatine block with local anesthetic |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults patients of ASA physical status I and II, aged 20-70 year who will be scaduled for Maxillo - facial cancer surgeries
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sphenopalatine block with local anestheticbilateral ultrasonic guided sphenopalatine ganglion block using local anesthetic after induction of general anesthesia in maxilofacial cancer surgeries | Other | sphenopalatine block using saline |
| sphenopalatine block with salinebilateral ultrasonic guided sphenopalatine ganglion block using saline after induction of general anesthesia in maxilofacial cancer surgeries | Other | sphenopalatine block using local anasthetic |
Primary outcome
Post - operative analgesia
Time frame: 24 hours postopeatively
according to VAS measured in the postoperative period
2 secondary outcomes
total dose of analgesic consumption
Time frame: 24 hours
number of patients required analgesia
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sphenopalatine block with local anesthetic and sphenopalatine block with saline in people with Maxillofacial Tumors, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post - operative analgesia (time frame: 24 hours postopeatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.