Subconjunctival Bupivacaine in Strabismus Surgery

NCT ID: NCT04782960

Last Updated: 2021-03-04

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2021-05-31

Brief Summary

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This study aimed to assess the effectiveness of the Subconjunctival bupivacaine on postoperative pain in Strabismus surgery under general anaesthesia.

Detailed Description

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40 patients will schedule for elective Strabismus surgery under general anaesthesia and randomly allocated into two groups to receive Subconjunctival 0.5%Bupivacaine group(B) or Subconjunctival placebo 0.9% normal saline group at the end of the surgery and assess the postoperative pain at 0th,30th, 60th,2nd h, 4h,6h,12h,24h.and post operative nausea and vomiting.

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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20 patients receive Subconjunctival bupivacaine of the end of the surgery

20 patients receive Subconjunctival bupivacaine in the end of operation and monitoring postoperative pain score

Group Type ACTIVE_COMPARATOR

Iocal anaesthetic bupivacaine

Intervention Type DRUG

Local anaesthetic Subconjunctival bupivacaine

20 patients receive Subconjunctival placebo in the end of operation

20 patients receive Subconjunctival placebo in the end of operation and monitoring postoperative pain score

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9 saline

Interventions

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Iocal anaesthetic bupivacaine

Local anaesthetic Subconjunctival bupivacaine

Intervention Type DRUG

Placebo

0.9 saline

Intervention Type DRUG

Other Intervention Names

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Group (p) Group (s)

Eligibility Criteria

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Inclusion Criteria

* All patients aged 14 \_30 years old with body mass index 18\_28kg/m.
* American Anaesthesiologist Association physical states I,II.
* singed informed consent to participate in the study and were scheduled for strabismus operations under general anaesthesia.

Exclusion Criteria

* were patients with chronic pain.
* ocular hypertension.
* inability to communicate.
* history of hematological disease.
* allergy to local anesthetic drugs.
Minimum Eligible Age

14 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fayoum University

OTHER

Sponsor Role lead

Responsible Party

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abeer shaban

Lecture of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammad A Hamed, MD

Role: STUDY_DIRECTOR

Fayoum University Hospital

Central Contacts

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Abeer Sh Goda

Role: CONTACT

01005151706

Amr H Mahmoud, Msc

Role: CONTACT

01004349592 ext. 002

Other Identifiers

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Subconjunctival bupivacaine

Identifier Type: -

Identifier Source: org_study_id

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