Combined Epidural Morphine and Midazolam on Postoperative Pain
Primary Purpose
Acute Postoperative Pain
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
midazolam
Sponsored by
About this trial
This is an interventional treatment trial for Acute Postoperative Pain focused on measuring epidural, morphine, midazolam, acute postoperative pain
Eligibility Criteria
Inclusion Criteria:
- ASA I-II patients scheduled for major abdominal cancer surgeries
Exclusion Criteria:
- patients with known allergy to the study drugs,
- significant cardiac, respiratory, renal or hepatic disease,
- drug or alcohol abuse,
- psychiatric illness that would interfere with perception and assessment of pain.
Sites / Locations
- Assiut UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
MI
MM
MO
Arm Description
Bupivacaine 0.25% + midazolam 5mg in total volume 10m1
Bupivacaine 0.25% + midazolam 5mg and morphine 5mg in total volume 10ml
bupivacaine 0.25% + morphine 5 mg in total volume 10 ml
Outcomes
Primary Outcome Measures
time to first request of analgesia
the time between the end of operation and tracheal extubation to the first request for supplemental analgesics and its administration to the patient
Secondary Outcome Measures
the cumulative consumption of morphine in the 1st 48h postoperatively
total amount of morphine used for analgesia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04033471
Brief Title
Combined Epidural Morphine and Midazolam on Postoperative Pain
Official Title
Effect of Epidural Morphine and Midazolam on Postoperative Painin Patients Undergoing Major Abdominal Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
this study aim to Compare the effect of preoperative Epidural Midazolam, Morphine and their combination in postoperative pain relief and total morphine consumption.
Detailed Description
Major abdominal surgeries with abdominal incisions lead to severe abdominal pain, which if treated inadequately, can cause shallow breathing, atelectasis, retention of secretions and lack of cooperation in physiotherapy. This increases the incidence of post-operative morbidity and leads to delayed recovery.Epidural anesthesia is safe and inexpensive technique with the advantage of providing surgical anesthesia and prolonged postoperative pain relief. It also an effective treatment of operative pain blunts autonomic, somatic and endocrine responses. Morphine and midazolam can be used as adjuvant to bupivicain to reduced the postoperative pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Postoperative Pain
Keywords
epidural, morphine, midazolam, acute postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
epidural bupiviacain
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MI
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.25% + midazolam 5mg in total volume 10m1
Arm Title
MM
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.25% + midazolam 5mg and morphine 5mg in total volume 10ml
Arm Title
MO
Arm Type
Active Comparator
Arm Description
bupivacaine 0.25% + morphine 5 mg in total volume 10 ml
Intervention Type
Drug
Intervention Name(s)
midazolam
Other Intervention Name(s)
morphine, bupivacaine
Intervention Description
epidural needle in the L1-2 or L2-3 space , and using loss of resistance technique udder strict aseptic condition 10 ml of the prepared drug will be given
Primary Outcome Measure Information:
Title
time to first request of analgesia
Description
the time between the end of operation and tracheal extubation to the first request for supplemental analgesics and its administration to the patient
Time Frame
1st 48 hours postoperative
Secondary Outcome Measure Information:
Title
the cumulative consumption of morphine in the 1st 48h postoperatively
Description
total amount of morphine used for analgesia
Time Frame
1st 48 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-II patients scheduled for major abdominal cancer surgeries
Exclusion Criteria:
patients with known allergy to the study drugs,
significant cardiac, respiratory, renal or hepatic disease,
drug or alcohol abuse,
psychiatric illness that would interfere with perception and assessment of pain.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shereen M Kamal, Associate proferssor
Phone
01006279209
Email
sheridouh79@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled M Fares, proferssor
Phone
01289757288
Email
faressali@yahoo.com
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
171516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shereen M Kamal, Degree
Phone
01006279209
Email
sheridouh79@yahoo.com
First Name & Middle Initial & Last Name & Degree
Khaled M Fares, Professor
Phone
01289757288
Email
faressali@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Combined Epidural Morphine and Midazolam on Postoperative Pain
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