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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Postoperative Pain focused on measuring epidural, morphine, midazolam, acute postoperative pain

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 24, 2019
Last Updated
February 23, 2021
Sponsor
Assiut University
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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

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Combined Epidural Morphine and Midazolam on Postoperative Pain

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