Combined Epidural Morphine and Midazolam on Postoperative Pain

NCT ID: NCT04033471

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-04-30

Brief Summary

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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

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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

Conditions

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Acute Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

epidural bupiviacain
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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MI

Bupivacaine 0.25% + midazolam 5mg in total volume 10m1

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

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

MM

Bupivacaine 0.25% + midazolam 5mg and morphine 5mg in total volume 10ml

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

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

MO

bupivacaine 0.25% + morphine 5 mg in total volume 10 ml

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

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

Interventions

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midazolam

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

Intervention Type DRUG

Other Intervention Names

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morphine bupivacaine

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shereen Mamdouh

associate professor of anesthesia, ICU and pain manegement

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Shereen M Kamal, Associate proferssor

Role: CONTACT

01006279209

Khaled M Fares, proferssor

Role: CONTACT

01289757288

Facility Contacts

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Shereen M Kamal, Degree

Role: primary

01006279209

Khaled M Fares, Professor

Role: backup

01289757288

Other Identifiers

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464

Identifier Type: -

Identifier Source: org_study_id

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