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

October 24, 2022 updated by: Research Institute of Ophthalmology, Egypt

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Research Institute of Ophthalmology
        • Contact:
          • Abeer Samir Salem, MD
          • Phone Number: 00201125666006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain during muscle traction
Time Frame: Intraoperative period
numeric rating Scale for pain a scale from 0 to 10 where 0 is no pain and 10 is unbearable pain
Intraoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgeon satisfaction
Time Frame: intraoperative
yes or no
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Institute of Ophthalmology, Egypt

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

September 10, 2022

First Submitted That Met QC Criteria

September 10, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00abeer00

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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