An Early Phase 1 interventional study of Fentanyl in Pain, sponsored by Research Institute of Ophthalmology, Egypt. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by Research Institute of Ophthalmology, Egypt · Early Phase 1, Interventional, and Prevention
The use of fentanyl as an adjuvant to local anesthetic mixture in many regional blocks. It was effective when used in peribulbar block in cataract and vitreoretinal surgeries.
Our study will assess its efficacy in abolishing pain during muscle traction which is usually a complain for many patients a reason to use systemic opioid intra operatively or even general anesthesia
After the patient enters the OR room, an intravenous cannula will be introduced, pulse oximeter, ECG and NIBP monitors will be connected.
Nasal oxygen cannula connected; 10 ml of local anesthetic mixture is injected depending on the group the patient is allocated.
Increments of intravenous intravenous fentanyl and midazolam will be given if patient experienced unbearable pain.
All patient received peribulbar block by an experienced anesthesiologist, both patient and anesthesiologist were blinded to the drug mixture used.
Each patient received 10 ml of the anesthetic mixture according to his/ her group.
The patient was asked to fix his eyes looking straight forward toward the ceiling while lying in a supine position. A 10 ml syringe with a 25G needle was used for the local anesthetic injection. After negative aspiration, the first 5 ml were slowly injected at the junction of the lateral one third and medial two thirds of the inferior orbital margin with the bevel directed towards the equator of the eye ball parallel to the orbital floor and the other 5 ml were given between the caruncle and the medial canthus. Intermittent gentle massage was applied for 10 minutes. After satisfactory sensory and motor block, oxygen 3 L/min was delivered through a nasal cannula to the patient. Surgery was then allowed to proceed.
Research Institute of Ophthalmology, Egypt is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patient received 50 mic fentanyl as an adjuvant to the local anesthetic mixture applied during peribulbar block in the operative eye
Drug: Fentanyl
received the traditional mixture used
Drug: Fentanyl
50 mic fentanyl added as an adjuvant
pain during muscle traction
numeric rating Scale for pain a scale from 0 to 10 where 0 is no pain and 10 is unbearable pain
Time frame: Intraoperative period
surgeon satisfaction
yes or no
Time frame: intraoperative
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Research Institute of Ophthalmology, Egypt