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

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05539911
• Other study ID #: 00abeer00
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 1, 2022
• Est. completion date: November 2022

Study information

• Verified date: October 2022
• Source: Research Institute of Ophthalmology, Egypt
• Contact: abeer S Salem, MD
• Phone: 01125666006
• Email: abeersamirali[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Fentanyl
50 mic fentanyl added as an adjuvant

Locations

Country	Name	City	State
Egypt	Research Institute of Ophthalmology	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute of Ophthalmology, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	surgeon satisfaction	yes or no	intraoperative