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

Study Overview
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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.

Official Title
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Phase 4 Study of Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration For Total Abdominal Hysterectomy

Conditions
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Pain

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Levobupivacaine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>%0.25 40 ml levobupivacaine and 2 mcg/kg dexmedetomidine administered via wound infiltration just before the incision. | Drug: Dexmedetomidine<br>* 2mcg.kg-1 dexmedetomidine wound infiltration<br>* Other names: precedex;Drug: Levobupivacaine<br>* 0.25% levobupivacaine (40ml) wound infiltration<br>* Other names: chirocaine;|
| Active Comparator: Levobupivacaine<br>%0.25 40 ml levobupivacaine administered via wound infiltration prior to incision. | Drug: Levobupivacaine<br>* 0.25% levobupivacaine (40ml) wound infiltration<br>* Other names: chirocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic Consumption | Pethidine consumption (patient controlled analgesia procedure) was recorded | 1 day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | Visual analog scale on rest and movement was recorded. | 1 day after surgery | 
| Haemodynamic Changes | Arterial blood pressure, heart rate, peripheral oxygen saturation | During the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, wound infiltration, postoperative analgesia