Peribulbar Block Versus Subtenon's Injection in Redo Vitreoretinal Surgery

Analgesia Clinical Trial

— subtenon's  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04978415
• Other study ID #: subtenon's RIO
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: November 30, 2022

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age between 18 and 80

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Analgesia

Intervention

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.

Locations

Country	Name	City	State
Egypt	Research Institute of Ophthalmology	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Abeer Samir Salem	Research Institute of Ophthalmology, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)