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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

Tracking Information
First Submitted Date  ICMJE August 21, 2013
First Posted Date  ICMJE August 27, 2013
Last Update Posted Date August 27, 2013
Study Start Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
Analgesic Consumption [ Time Frame: 1 day after surgery ]
Pethidine consumption (patient controlled analgesia procedure) was recorded
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
  • Visual Analog Scale [ Time Frame: 1 day after surgery ]
    Visual analog scale on rest and movement was recorded.
  • Haemodynamic Changes [ Time Frame: During the surgery ]
    Arterial blood pressure, heart rate, peripheral oxygen saturation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration for Total Abdominal Hysterectomy
Official Title  ICMJE Phase 4 Study of Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration For Total Abdominal Hysterectomy
Brief Summary The aim of this study was to investigate the analgesic efficacy of dexmedetomidine administration in wound infiltration for total abdominal hysterectomy.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Dexmedetomidine
    2mcg.kg-1 dexmedetomidine wound infiltration
    Other Name: precedex
  • Drug: Levobupivacaine
    0.25% levobupivacaine (40ml) wound infiltration
    Other Name: chirocaine
Study Arms  ICMJE
  • Active Comparator: Dexmedetomidine
    %0.25 40 ml levobupivacaine and 2 mcg/kg dexmedetomidine administered via wound infiltration just before the incision.
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Levobupivacaine
  • Active Comparator: Levobupivacaine
    %0.25 40 ml levobupivacaine administered via wound infiltration prior to incision.
    Intervention: Drug: Levobupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2013)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01929252
Other Study ID Numbers  ICMJE 2011/07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ayse Ulgey, TC Erciyes University
Study Sponsor  ICMJE TC Erciyes University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fatih M. Kurt, Resident TC Erciyes University
Study Director: Ayse Ulgey, Asst. Prof TC Erciyes University
PRS Account TC Erciyes University
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP