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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05539911
Enrollment
50
Registered
2022-09-14
Start date
2022-09-01
Completion date
2022-11-30
Last updated
2022-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

DRUGFentanyl

50 mic fentanyl added as an adjuvant

Sponsors

Research Institute of Ophthalmology, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pain during muscle tractionIntraoperative periodnumeric rating Scale for pain a scale from 0 to 10 where 0 is no pain and 10 is unbearable pain

Secondary

MeasureTime frameDescription
surgeon satisfactionintraoperativeyes or no

Countries

Egypt

Contacts

Primary Contactabeer S Salem, MD
abeersamirali@gmail.com01125666006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026