Maxillofacial Tumors Clinical Trial
Official title:
Efficacy of Bilaterally Ultrasonic Guided Sphenopalatine Ganglion Block for Perioperative Pain Management in Maxilofacial Cancer Surgeries
| NCT number | NCT03171090 |
| Other study ID # | IORG0003381 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 5, 2017 |
| Est. completion date | March 15, 2018 |
| Verified date | October 2019 |
| Source | Assiut University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | March 15, 2018 |
| Est. primary completion date | October 1, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | NCI, Cairo university | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University | Cairo University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Post - operative analgesia | according to VAS measured in the postoperative period | 24 hours postopeatively | |
| Secondary | total dose of analgesic consumption | total nalufen dose | 24 hours | |
| Secondary | number of patients required analgesia | number of patients required nalufen | 24 hours |