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Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration for Total Abdominal Hysterectomy

NCT ID: NCT01929252

Last Updated: 2013-08-27

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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Abdominal hysterectomy is associated with moderate to severe postoperative pain, effective analgesia after hysterectomy essential and several techniques are used such as administration of opioids, nonsteroidal anti-inflammatory drugs and wound infiltration of local anaesthetics. Different local anaesthetics can be used for the wound infiltration techniques.Ifiltration of the surgical wound with bupivacaine following outpatient provides pain relief in the postoperative period , allows the early discharge from the outpatient surgical units.There has been increased interest in administration of analgesic prior to surgical injury. Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with sedative , anxiolytic, analgesic, sympatholytic and antihypertensive effects.Dexmedetomidine has been used intravenously before initiation of anaesthesia and it has shown to provide some analgesic effect after surgery but there were some adverse hemodynamic effects. Surgical wound administration of dexmedetomidine may be useful to avoid the adverse haemodynamic effects of intravenous administration while still providing the postoperative analgesia.

Conditions

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Pain

Keywords

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dexmedetomidine wound infiltration postoperative analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

2mcg.kg-1 dexmedetomidine wound infiltration

Levobupivacaine

Intervention Type DRUG

0.25% levobupivacaine (40ml) wound infiltration

Levobupivacaine

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

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

0.25% levobupivacaine (40ml) wound infiltration

Interventions

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Dexmedetomidine

2mcg.kg-1 dexmedetomidine wound infiltration

Intervention Type DRUG

Levobupivacaine

0.25% levobupivacaine (40ml) wound infiltration

Intervention Type DRUG

Other Intervention Names

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precedex chirocaine

Eligibility Criteria

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Inclusion Criteria

* 18-65 yo female
* scheduled for elective hysterectomy
* no known allergies to drugs
* ASA 1=2 patients

Exclusion Criteria

* history of diabetes
* history of chronic pain treatment
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Ayse Ulgey

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatih M. Kurt, Resident

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Ayse Ulgey, Asst. Prof

Role: STUDY_DIRECTOR

TC Erciyes University

Locations

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Erciyes university hospital

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2011/07

Identifier Type: -

Identifier Source: org_study_id