NCT03046719

Brief Summary

The study aimed to investigate the effectivity of bupivacaine 0,5% as post-operative analgesia in intravitreal silicone evacutaion surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

February 5, 2017

Last Update Submit

February 5, 2017

Conditions

Retinal Detachment

Keywords

bupivacaineintravitrealanalgesiasilicone oil removalretinal detachmentsubconjunctival

Outcome Measures

Primary Outcomes (1)

  • The degree of pain

    The degree of pain was measured in the morning after the surgery by Visual Analog Scale (VAS).

    2 months

Secondary Outcomes (2)

  • The time for first requested post-operative additional analgesia

    2 months

  • Side Effects

    2 months

Study Arms (2)

Bupivacaine 0,5%

ACTIVE COMPARATOR

Subjects received subconjunctival bupivacaine 0,5% 2,5ml in between stitches.

Drug: Bupivacaine 0,5%

NaCl 0,9%

PLACEBO COMPARATOR

Subjects received subconjunctival NaCl 0,9% in between stitches.

Drug: NaCl 0,9%

Interventions

Bupivacaine 0,5%DRUG

Bupivacaine 0,5% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches

Bupivacaine 0,5%
NaCl 0,9%DRUG

NaCl 0,9% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches

NaCl 0,9%

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects aged 18-60 years old, with ASA physical status I-II and BMI 18,5-30 kg/m2 who were planned to do intravitreal silicone evacuation surgery.
  • Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form

You may not qualify if:

  • Subjects with history of post-operative chronic pain
  • Subjects with history of pre-operative long term use of analgesic
  • Subjects with history of local anesthetics allergy, pregnant subjects
  • Subjects with ambulation operation
  • Subjects with glaucoma or ocular hypertension
  • Subjects with cognition dysfunction or communication disturbance
  • Subjects with additional surgery other than silicone oil removal
  • Drop Out criteria:
  • Subjects with intraoperative complications (e.g. shock, anaphylactic reaction, seizures, severe respiratory disturbance)
  • Subjects with post-operative intraocular pressure \> 22mmHg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Central Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (5)

  • Fekrat S, Elsing SH, Raja SC, Campochiaro PA, de Juan E Jr, Haller JA. Eye pain after vitreoretinal surgery: a prospective study of 185 patients. Retina. 2001;21(6):627-32. doi: 10.1097/00006982-200112000-00010.

    PMID: 11756886BACKGROUND

  • Bartley EJ, Fillingim RB. Sex differences in pain: a brief review of clinical and experimental findings. Br J Anaesth. 2013 Jul;111(1):52-8. doi: 10.1093/bja/aet127.

    PMID: 23794645BACKGROUND

  • Wandner LD, Scipio CD, Hirsh AT, Torres CA, Robinson ME. The perception of pain in others: how gender, race, and age influence pain expectations. J Pain. 2012 Mar;13(3):220-7. doi: 10.1016/j.jpain.2011.10.014. Epub 2012 Jan 5.

    PMID: 22225969BACKGROUND

  • Fillingim RB, King CD, Ribeiro-Dasilva MC, Rahim-Williams B, Riley JL 3rd. Sex, gender, and pain: a review of recent clinical and experimental findings. J Pain. 2009 May;10(5):447-85. doi: 10.1016/j.jpain.2008.12.001.

    PMID: 19411059BACKGROUND

  • Belmonte C, Aracil A, Acosta MC, Luna C, Gallar J. Nerves and sensations from the eye surface. Ocul Surf. 2004 Oct;2(4):248-53. doi: 10.1016/s1542-0124(12)70112-x.

    PMID: 17216099BACKGROUND

MeSH Terms

Conditions

Retinal DetachmentAgnosia

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Anesthesiologist

Study Record Dates

First Submitted

February 5, 2017

First Posted

February 8, 2017

Study Start

September 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

ID(1)