Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929252
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : August 27, 2013
Sponsor:
Information provided by (Responsible Party):
Ayse Ulgey, TC Erciyes University

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

Condition or disease Intervention/treatment Phase
Pain Drug: Dexmedetomidine Drug: Levobupivacaine Phase 4

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration For Total Abdominal Hysterectomy
Study Start Date : August 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexmedetomidine
%0.25 40 ml levobupivacaine and 2 mcg/kg dexmedetomidine administered via wound infiltration just before the incision.
Drug: Dexmedetomidine
2mcg.kg-1 dexmedetomidine wound infiltration
Other Name: precedex

Drug: Levobupivacaine
0.25% levobupivacaine (40ml) wound infiltration
Other Name: chirocaine

Active Comparator: Levobupivacaine
%0.25 40 ml levobupivacaine administered via wound infiltration prior to incision.
Drug: Levobupivacaine
0.25% levobupivacaine (40ml) wound infiltration
Other Name: chirocaine




Primary Outcome Measures :
  1. Analgesic Consumption [ Time Frame: 1 day after surgery ]
    Pethidine consumption (patient controlled analgesia procedure) was recorded


Secondary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: 1 day after surgery ]
    Visual analog scale on rest and movement was recorded.

  2. Haemodynamic Changes [ Time Frame: During the surgery ]
    Arterial blood pressure, heart rate, peripheral oxygen saturation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929252


Locations
Layout table for location information
Turkey
Erciyes university hospital
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
Layout table for investigator information
Principal Investigator: Fatih M. Kurt, Resident TC Erciyes University
Study Director: Ayse Ulgey, Asst. Prof TC Erciyes University
Layout table for additonal information
Responsible Party: Ayse Ulgey, Assistant Professor, TC Erciyes University
ClinicalTrials.gov Identifier: NCT01929252    
Other Study ID Numbers: 2011/07
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: August 27, 2013
Last Verified: August 2013
Keywords provided by Ayse Ulgey, TC Erciyes University:
dexmedetomidine
wound infiltration
postoperative analgesia
Additional relevant MeSH terms:
Layout table for MeSH terms
Dexmedetomidine
Levobupivacaine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics