Peribulbar Block Versus Subtenon's Injection in Redo Vitreoretinal Surgery (subtenon's)

Comparative Study Between Peribulbar Block Technique and Sub-Tenon's Technique in Adult Patients Undergoing Redo Vitreoretinal Surgery: RCT

To compare the efficacy and efficiency of peribulbar block versus sub-Tenon's capsule injection of local anesthetic in redo vitreoretinal surgery

Study Overview

• Status: Recruiting
• Conditions: Analgesia
• Intervention / Treatment: Procedure: peribulbar block versus subtenon's block

Detailed Description

Sixty patients undergoing vitreoretinal surgery were randomized to receive either peribulbar or sub-Tenon's capsule injection of 8 ml of a 20:80 mixture of 2% lidocaine and 0.5% bupivacaine with 60 IU hyalouronic acid.

The primary outcome measured was intraoperative eye pain, which was rated by patients in both groups using an 11-point (0-10) numerical visual analogue scale immediately after.

The surgeons indicated whether they perceived patient discomfort during 4 different stages of the operation: opening of the conjunctiva, vitrectomy (if performed), placement of scleral buckle (if performed) or using the laser probe, and closing of the conjunctiva.

The need for supplemental local anesthesia, and use of IV sedation for additional pain control intraoperatively were compared between the two groups.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abeer Samir, MD; Phone Number: 01125666006; Email: abeersamirali@gmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age between 18 and 80

Exclusion Criteria:

• Uncooperative patients
• Bleeding disorders
• High axial length (30mm) with previous buckle surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: subtenon's block; we use the subtenon cannula to inject the local anesthetic mixture	Procedure: peribulbar block versus subtenon's block; Sixty patients undergoing vitreoretinal surgery were randomized to receive either peribulbar or sub-Tenon's capsule injection of 8 ml of a 20:80 mixture of 2% lidocaine and 0.75% bupivacaine with 60 IU hyalouronic acid. two groups 30 patient each (group p and group s) after connecting the patient to the monitor, we give him sedation 50 mg propofol, apply a nasal cannula group P: receives 2 injection peribulbar block group S: receives single injection subtenon Patients rate their pain sensation in both groups using an 11-point (0-10) numerical visual analogue scale immediately after surgery.
Experimental: peribulbar block; we use the usual 25G sharp needle to inject the local anesthetic mixture	Procedure: peribulbar block versus subtenon's block; Sixty patients undergoing vitreoretinal surgery were randomized to receive either peribulbar or sub-Tenon's capsule injection of 8 ml of a 20:80 mixture of 2% lidocaine and 0.75% bupivacaine with 60 IU hyalouronic acid. two groups 30 patient each (group p and group s) after connecting the patient to the monitor, we give him sedation 50 mg propofol, apply a nasal cannula group P: receives 2 injection peribulbar block group S: receives single injection subtenon Patients rate their pain sensation in both groups using an 11-point (0-10) numerical visual analogue scale immediately after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative pain	11 point verbal rating score from 0 to 10 where 0 is no pain and 10 is intolerable pain patient will be asked immediately after surgery about pain the need for intraoperative sedation will be recorded	during whole surgery duration (around 2 hours)

Collaborators and Investigators

• Sponsor: Abeer Samir Salem
• Collaborators: Research Institute of Ophthalmology, Egypt
• Investigators: Principal Investigator: Abeer Samir, MD, Research Institute of Ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 25, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 10, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: subtenon's RIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No