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Fentanyl as an Adjuvant to Peribulbar Block in Buckle or Squint Surgeries

Early Phase 1
Recruiting
Conditions
Pain
Interventions
Registration Number
NCT05539911
Lead Sponsor
Research Institute of Ophthalmology, Egypt
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
50
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
group fFentanylpatient received 50 mic fentanyl as an adjuvant to the local anesthetic mixture applied during peribulbar block in the operative eye
group CFentanylreceived the traditional mixture used
Primary Outcome Measures
NameTimeMethod
pain during muscle tractionIntraoperative period

numeric rating Scale for pain a scale from 0 to 10 where 0 is no pain and 10 is unbearable pain

Secondary Outcome Measures
NameTimeMethod
surgeon satisfactionintraoperative

yes or no

Trial Locations

Locations (1)

Research Institute of Ophthalmology

🇪🇬

Giza, Egypt

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