Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

intrathecaم Ketamine, Morphine and Both for Lower Abdominal Cancer Surgery Pain

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: NCT02726828
Recruitment Status : Completed
First Posted : April 4, 2016
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmad Mohammad Abd El-Rahman, Assiut University

Tracking Information
First Submitted Date  ICMJE March 30, 2016
First Posted Date  ICMJE April 4, 2016
Last Update Posted Date January 26, 2017
Study Start Date  ICMJE October 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
  • Visual Analogue Scale (VAS) scores [ Time Frame: 24 hours postoperative ]
    postoperative pain measured by this score.
  • time to first analgesic request [ Time Frame: 24 hours postoperative ]
    the time passed till the first request of rescue analgesia by the patients
  • total analgesic consumption [ Time Frame: 24 hours postoperative ]
    the total amount of rescue analgesic drug used allover follow up period
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
side effects [ Time Frame: 24 hours postoperative ]
the type and rate of incidence of side effects during the follow up period
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 intrathecaم Ketamine, Morphine and Both for Lower Abdominal Cancer Surgery Pain
Official Title  ICMJE Effects of Intrathecally Administered Ketamine, Morphine and Their Combination in Patients Undergoing Major Abdominal Cancer Surgery
Brief Summary this study investigates the analgesic efficacy and other possible effects of ketamine, morphine, and both together when administered intrathecally for control of postoperative pain following lower abdominal cancer surgeries.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: intrathecal morphine
    patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg intrathecal morphine1 ml volume.
  • Drug: intrathecal ketamine
    patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg intrathecal ketamine in 1ml volume.
  • Drug: intrathecal morphine + ketamine
    patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and intrathecal morphine + ketamine 0.3 mg and 0.1 mg/kg respectively in 1 ml volume.
Study Arms  ICMJE
  • Active Comparator: group I: morphine group
    patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine in 1 ml volume intrathecally.
    Intervention: Drug: intrathecal morphine
  • Active Comparator: group II: ketamine group
    patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume intrathecally.
    Intervention: Drug: intrathecal ketamine
  • Active Comparator: group III: morphine + ketamine group
    patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine plus 0.1 mg/kg of Ketamine in 1 ml volume intrathecally.
    Intervention: Drug: intrathecal morphine + ketamine
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: March 30, 2016)
90
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American Society of Anesthesia (ASA) I-III patients.
  • aged 30-50 years.
  • scheduled for major abdominal cancer surgery.

Exclusion Criteria:

  • Patients with a known allergy to the study drugs.
  • significant cardiac, respiratory, renal or hepatic disease.
  • coagulation disorders.
  • infection at or near the site of intrathecal injection.
  • drug or alcohol abuse.
  • BMI > 30 kg/m2.
  • psychiatric illnesses that may interfere with perception and assessment of pain.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02726828
Other Study ID Numbers  ICMJE 165
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ahmad Mohammad Abd El-Rahman, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date January 2017

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