Back to resultsintrathecaم Ketamine, Morphine and Both for Lower Abdominal Cancer Surgery Pain
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
intrathecal morphine
intrathecal ketamine
intrathecal morphine + ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
group I: morphine group
group II: ketamine group
group III: morphine + ketamine group
Arm Description
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine in 1 ml volume intrathecally.
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume intrathecally.
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.
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS) scores
postoperative pain measured by this score.
time to first analgesic request
the time passed till the first request of rescue analgesia by the patients
total analgesic consumption
the total amount of rescue analgesic drug used allover follow up period
Secondary Outcome Measures
side effects
the type and rate of incidence of side effects during the follow up period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02726828
Brief Title
intrathecaم Ketamine, Morphine and Both for Lower Abdominal Cancer Surgery Pain
Official Title
Effects of Intrathecally Administered Ketamine, Morphine and Their Combination in Patients Undergoing Major Abdominal Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group I: morphine group
Arm Type
Active Comparator
Arm Description
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine in 1 ml volume intrathecally.
Arm Title
group II: ketamine group
Arm Type
Active Comparator
Arm Description
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume intrathecally.
Arm Title
group III: morphine + ketamine group
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
intrathecal morphine
Intervention Description
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg intrathecal morphine1 ml volume.
Intervention Type
Drug
Intervention Name(s)
intrathecal ketamine
Intervention Description
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg intrathecal ketamine in 1ml volume.
Intervention Type
Drug
Intervention Name(s)
intrathecal morphine + ketamine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) scores
Description
postoperative pain measured by this score.
Time Frame
24 hours postoperative
Title
time to first analgesic request
Description
the time passed till the first request of rescue analgesia by the patients
Time Frame
24 hours postoperative
Title
total analgesic consumption
Description
the total amount of rescue analgesic drug used allover follow up period
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
side effects
Description
the type and rate of incidence of side effects during the follow up period
Time Frame
24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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intrathecaم Ketamine, Morphine and Both for Lower Abdominal Cancer Surgery Pain
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