Peribulbar Block Versus Subtenon's Injection in Redo Vitreoretinal Surgery

NCT ID: NCT04978415

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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subtenon's block

we use the subtenon cannula to inject the local anesthetic mixture

Group Type EXPERIMENTAL

peribulbar block versus subtenon's block

Intervention Type PROCEDURE

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.

peribulbar block

we use the usual 25G sharp needle to inject the local anesthetic mixture

Group Type EXPERIMENTAL

peribulbar block versus subtenon's block

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age between 18 and 80

Exclusion Criteria

* Uncooperative patients
* Bleeding disorders
* High axial length (30mm) with previous buckle surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Research Institute of Ophthalmology, Egypt

OTHER

Sponsor Role collaborator

Abeer Samir Salem

OTHER

Sponsor Role lead

Responsible Party

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Abeer Samir Salem

Researcher of anesthesia

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Abeer Samir, MD

Role: PRINCIPAL_INVESTIGATOR

research institute of ophthalmology

Locations

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Research Institute of Ophthalmology

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Abeer Samir, MD

Role: CONTACT

01125666006

Facility Contacts

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Abeer Samir Salem, MD

Role: primary

00201125666006

Other Identifiers

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subtenon's RIO

Identifier Type: -

Identifier Source: org_study_id

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