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Effect of Wound Infiltration by Ketamine Versus Dexmedetomidine Added to Bupivacaine on Surgical Stress

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ClinicalTrials.gov Identifier: NCT02927379
Recruitment Status : Completed
First Posted : October 7, 2016
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Fatma Adel El sherif, Assiut University

Study Description
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Brief Summary:
This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on stress response and postoperative pain in lower abdominal cancer surgery.

Condition or disease Intervention/treatment Phase
Abdominal Cancer Drug: Dexmedetomidine Drug: Ketamine Drug: Bupivacaine Phase 3

Detailed Description:

Patients will be randomly assigned using an online research randomizer into three groups, 30 patients in each group:

Group C:

30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision( control group).

Group K:

30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline +1 mg /kg ketamine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.

Group D:

30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline + 1µg/kg dexmedetomidine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Effects of Local Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Surgical Stress Response and Postoperative Pain in Major Abdominal Cancer Surgery
Study Start Date : June 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : October 2017

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ketamine group
intervention: local wound infiltration 30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline +1 mg /kg ketamine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.
 Drug: Ketamine
local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline plus ketamine in two divided doses i.e. 20 ml is administered on each side of incision
Other Name: subcutaneous
Active Comparator: dexmedetomidine group
intervention: local wound infiltration 30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline + 1µg/kg dexmedetomidine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.
 Drug: Dexmedetomidine
local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline plus dexmetedomidine in two divided doses i.e. 20 ml is administered on each side of incision
Other Name: subcutaneous
Placebo Comparator: bupivacaine group
intervention: local wound infiltration 30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision( control group).
 Drug: Bupivacaine
local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline only in two divided doses i.e. 20 ml is administered on each side of incision
Other Name: subcutaneous


Outcome Measures
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Primary Outcome Measures :
  1. Total morphine consumption [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Plasma concentrations of prolactin, cortisol and glucose level [ Time Frame: 24 hours ]
  2. the severity of pain was assessed using VAS score [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) class I-II Body weight of 50 - 90 kg

Exclusion Criteria:

  • History of bleeding diathesis
  • Relevant drug allergy, opioid dependence
  • Morbid obesity, sepsis
Contacts and Locations
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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): NCT02927379


Locations
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Egypt
South Egypt Cancer Instuite
Assuit, Egypt, 171516
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: fatma A EL sherif South Egypt Cancer Instuite, Assuit, Assuit university
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fatma Adel El sherif, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT02927379     History of Changes
Other Study ID Numbers: 248
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Dexmedetomidine
Ketamine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
 Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents