NCT02690506

Brief Summary

Pregabalin, an anticonvulsant is widely used for treatment of neuropathic pain. Recently, it was reported that premedication of pregabalin before general anesthesia is effective to reduce postoperative pain. Up to date, there is no study about the effect of premedication of pregabalin on the spinal anesthesia. Therefore, in this study, investigators investigate the effect of premedication of pregabalin on the spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

3 months

First QC Date

February 19, 2016

Last Update Submit

May 17, 2016

Conditions

Block

Keywords

pregabalinspinal anesthesia

Outcome Measures

Primary Outcomes (1)

  • Duration of spinal anesthesia

    Duration of spinal anesthesia was measured 24 after spinal anesthesia

    24 hours after spinal anesthesia

Study Arms (2)

Group C

PLACEBO COMPARATOR

Oral placebo pill was administered 2 hours before anesthesia

Drug: Placebo

Group P

ACTIVE COMPARATOR

Oral pregabalin 150 mg was administered 2 hours before anesthesia

Drug: Pregabalin

Interventions

PlaceboDRUG
Group C
PregabalinDRUG
Group P

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of American Society of Anaesthesiologists Grades I and II

You may not qualify if:

  • Patients with infection at the puncture site, coagulopathy, having true hypersensitivity to drugs used, diabetes and hypertension, psychiatric and neurological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

MeSH Terms

Conditions

Bites and Stings

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Younghoon Jeon, Dr

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 19, 2016

First Posted

February 24, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

KR(1)