Clinical trial NCT05539911: Fentanyl as an Adjuvant to Peribulbar Block in Buckle or Squint Surgeries
Official title: The Effect of Using Fentanyl as an Adjuvant to Peribulbar Block to Decrease the Introaoperative Muscle Traction Pain (Proprioception) in Squint and Buckle Surgeries in Adults: RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pain
Lead sponsor: Research Institute of Ophthalmology, Egypt
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ASA 1, 2 \& 3
* Age 18 to 70
* Patients undergoing squint or buckle surgeries

Exclusion Criteria:

* Sensitivity to any drug used in this study
* Refusal of the patient for peribulbar block
* Redo squint surgeries or previous buckle insertion
* High axial length if documented
* mentally retarded patients and
* failure of proper communication as in deafness,
* coagulation abnormalities (INR\>1.4),
* infection at the injection site

Primary outcomes:
measure: pain during muscle traction
timeFrame: Intraoperative period
Secondary outcomes:
measure: surgeon satisfaction
timeFrame: intraoperative
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Research Institute of Ophthalmology
Study officials:
affiliation: Research Institute of Ophthalmology
name: Abeer S Salem, MD
role: PRINCIPAL_INVESTIGATOR
References: