NCT01929252

Brief Summary

The aim of this study was to investigate the analgesic efficacy of dexmedetomidine administration in wound infiltration for total abdominal hysterectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Aug 2011

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

August 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
Last Updated

August 27, 2013

Status Verified

August 1, 2013

Enrollment Period

Same day

First QC Date

August 21, 2013

Last Update Submit

August 22, 2013

Conditions

Pain

Keywords

dexmedetomidinewound infiltrationpostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Analgesic Consumption

    Pethidine consumption (patient controlled analgesia procedure) was recorded

    1 day after surgery

Secondary Outcomes (2)

  • Visual Analog Scale

    1 day after surgery

  • Haemodynamic Changes

    During the surgery

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

%0.25 40 ml levobupivacaine and 2 mcg/kg dexmedetomidine administered via wound infiltration just before the incision.

Drug: DexmedetomidineDrug: Levobupivacaine

Levobupivacaine

ACTIVE COMPARATOR

%0.25 40 ml levobupivacaine administered via wound infiltration prior to incision.

Drug: Levobupivacaine

Interventions

DexmedetomidineDRUG

2mcg.kg-1 dexmedetomidine wound infiltration

Also known as: precedex
Dexmedetomidine
LevobupivacaineDRUG

0.25% levobupivacaine (40ml) wound infiltration

Also known as: chirocaine
DexmedetomidineLevobupivacaine

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yo female
  • scheduled for elective hysterectomy
  • no known allergies to drugs
  • ASA 1=2 patients

You may not qualify if:

  • history of diabetes
  • history of chronic pain treatment
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes university hospital

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

DexmedetomidineLevobupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Fatih M. Kurt, Resident

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

  • Ayse Ulgey, Asst. Prof

    TC Erciyes University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 21, 2013

First Posted

August 27, 2013

Study Start

August 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2012

Last Updated

August 27, 2013

Record last verified: 2013-08

Locations

TU(1)