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
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 pain
Started Sep 2022
Shorter than P25 for early_phase_1 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 10, 2022
CompletedFirst Posted
Study publicly available on registry
September 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedOctober 25, 2022
October 1, 2022
2 months
September 10, 2022
October 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Intraoperative period
Secondary Outcomes (1)
surgeon satisfaction
intraoperative
Study Arms (2)
group f
ACTIVE COMPARATORpatient received 50 mic fentanyl as an adjuvant to the local anesthetic mixture applied during peribulbar block in the operative eye
group C
PLACEBO COMPARATORreceived the traditional mixture used
Interventions
Eligibility Criteria
You may qualify if:
- ASA 1, 2 \& 3
- Age 18 to 70
- Patients undergoing squint or buckle surgeries
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Institute of Ophthalmology
Giza, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abeer S Salem, MD
Research Institute of Ophthalmology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2022
First Posted
September 14, 2022
Study Start
September 1, 2022
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
October 25, 2022
Record last verified: 2022-10