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

NCT ID: NCT05539911

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2022-11-30

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

group f

patient received 50 mic fentanyl as an adjuvant to the local anesthetic mixture applied during peribulbar block in the operative eye

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

50 mic fentanyl added as an adjuvant

group C

received the traditional mixture used

Group Type: PLACEBO_COMPARATOR

Fentanyl

Intervention Type: DRUG

50 mic fentanyl added as an adjuvant

Interventions

Fentanyl

50 mic fentanyl added as an adjuvant

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Institute of Ophthalmology, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abeer S Salem, MD

Role: PRINCIPAL_INVESTIGATOR

Research Institute of Ophthalmology

Locations

Research Institute of Ophthalmology

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

abeer S Salem, MD

Role: CONTACT

abeersamirali@gmail.com

01125666006 ext. 002

Facility Contacts

Abeer Samir Salem, MD

Role: primary

00201125666006

Other Identifiers

00abeer00

Identifier Type: -

Identifier Source: org_study_id