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

Sponsor

Abeer Samir Salem (Other)

Overall Status

Recruiting

CT.gov ID

NCT04978415

Collaborator

Research Institute of Ophthalmology, Egypt (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

12.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Procedure: peribulbar block versus subtenon's block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jul 30, 2022

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

intraoperative pain [during whole surgery duration (around 2 hours)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age between 18 and 80

Exclusion Criteria:

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Abeer Samir Salem
Research Institute of Ophthalmology, Egypt

Investigators

Principal Investigator: Abeer Samir, MD, research institute of ophthalmology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abeer Samir Salem, Researcher of anesthesia, Research Institute of Ophthalmology, Egypt

ClinicalTrials.gov Identifier:

NCT04978415

Other Study ID Numbers:

subtenon's RIO

First Posted:

Jul 27, 2021

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 2, 2022