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Effect of Perioperative iv Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption and Recovery After Abdominal Gynaecological Surgery

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: NCT03363425
Recruitment Status : Unknown
Verified December 2017 by Staikou Chryssoula, University of Athens.
Recruitment status was:  Recruiting
First Posted : December 6, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Staikou Chryssoula, University of Athens

Brief Summary:
Postoperative pain continues to be inadequately managed and is the most common reason for the delay in discharge and unplanned hospital admission after surgery. Opioids remain the mainstay for postoperative analgesia. However, there is a continuous search for adjuvant therapies to reduce the doses of opioids and their related adverse effects, and extend the use of non-opioid analgesia for acute pain after abdominal surgery, thereby improving patient recovery. Currently there are no clinical trials that investigate the effect of intravenous lidocaine vs dexmedetomidine on postoperative pain, analgesic consumption and bowel function of patients undergoing abdominal gynaecological surgery. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of lidocaine vs dexmedetomidine vs placebo (Normal Saline 0,9%) on analgesic parameters and functional recovery of patients undergoing abdominal gynaecological surgery.

Condition or disease Intervention/treatment Phase
Hysterectomy Myomectomy Drug: Lidocaine Iv Drug: Dexmedetomidine Drug: Normal saline Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Perioperative Intravenous Infusion of Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption, Bowel Function and Recovery After Abdominal Gynaecological Surgery: a Randomised Double Blind Study
Actual Study Start Date : November 14, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine Drug: Lidocaine Iv
Lidocaine Iv

Active Comparator: Dexmedetomidine Drug: Dexmedetomidine
dexmedetomidine iv

Placebo Comparator: Normal Saline 0,9% Drug: Normal saline
placebo




Primary Outcome Measures :
  1. analgesic consumption 24 hours postop [ Time Frame: 24 hours postoperatively ]
    morphine consumption from PCA


Secondary Outcome Measures :
  1. postoperative pain [ Time Frame: 0 hours postoperatively ]
    Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)

  2. postoperative pain [ Time Frame: 2 hours postoperatively ]
    Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)

  3. postoperative pain [ Time Frame: 4 hours postoperatively ]
    Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)

  4. postoperative pain [ Time Frame: 8 hours postoperatively ]
    Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)

  5. postoperative pain [ Time Frame: 24 hours postoperatively ]
    Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)

  6. postoperative pain [ Time Frame: 48 hours postoperatively ]
    Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women
  • ASA I-II
  • 30-70 years
  • abdominal gynaecological surgery

Exclusion Criteria:

  • patient's refusal
  • contraindication to the use of local anesthetics
  • body mass index >30 kg/m2
  • history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
  • pregnant women
  • significant renal or hepatic impairment
  • insulin-dependent diabetes mellitus
  • central nervous system disease or psychiatric diseases
  • chronic use of opioids, steroids, clonidine (or other a2 agonist)
  • use of drugs acting on the central nervous system or analgesics during the previous 2 weeks
  • drug/alcohol abuse
  • inability to comprehend the following pain assessment scale

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): NCT03363425


Locations
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Greece
Aretaieio University Hospital Recruiting
Athens, Greece
Contact: Martina Rekatsina    00306975104139    mrekatsina@gmail.com   
Sponsors and Collaborators
University of Athens
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Responsible Party: Staikou Chryssoula, Assistant Professor of Anaesthesiology, University of Athens
ClinicalTrials.gov Identifier: NCT03363425    
Other Study ID Numbers: EE-2/04/31-01-2017
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Staikou Chryssoula, University of Athens:
Dexmedetomidine
Lidocaine
Postoperative Pain
Analgesic Consumption
Recovery
Abdominal Gynaecological Surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Lidocaine
Dexmedetomidine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents