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

• Sponsor: Research Institute of Ophthalmology, Egypt (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05539911
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Fentanyl	Early Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group f patient received 50 mic fentanyl as an adjuvant to the local anesthetic mixture applied during peribulbar block in the operative eye	Drug: Fentanyl; 50 mic fentanyl added as an adjuvant
Placebo Comparator: group C received the traditional mixture used	Drug: Fentanyl; 50 mic fentanyl added as an adjuvant

Outcome Measures

Primary Outcome Measures

1. pain during muscle traction [Intraoperative period]

   numeric rating Scale for pain

Secondary Outcome Measures

1. surgeon satisfaction [intraoperative]

   yes or no

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Institute of Ophthalmology	Giza		Egypt

Sponsors and Collaborators

• Research Institute of Ophthalmology, Egypt

Investigators

• Principal Investigator: Abeer S Salem, MD, Research Institute of Ophthalmology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Research Institute of Ophthalmology, Egypt
• ClinicalTrials.gov Identifier: NCT05539911
• Other Study ID Numbers: 00abeer00
• First Posted: Sep 14, 2022
• Last Update Posted: Sep 14, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fentanyl

Study Results

No Results Posted as of Sep 14, 2022