Combined Epidural Morphine and Midazolam on Postoperative Pain

Study Overview
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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

Official Title
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Effect of Epidural Morphine and Midazolam on Postoperative Painin Patients Undergoing Major Abdominal Cancer Surgery

Conditions
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Acute Postoperative Pain

Intervention / Treatment
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* Drug: midazolam


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: epidural bupiviacain
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MI<br>Bupivacaine 0.25% + midazolam 5mg in total volume 10m1 | Drug: midazolam<br>* 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<br>* Other names: bupivacaine;|
| Active Comparator: MM<br>Bupivacaine 0.25% + midazolam 5mg and morphine 5mg in total volume 10ml | Drug: midazolam<br>* 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<br>* Other names: bupivacaine;|
| Active Comparator: MO<br>bupivacaine 0.25% + morphine 5 mg in total volume 10 ml | Drug: midazolam<br>* 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<br>* Other names: bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1st 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the cumulative consumption of morphine in the 1st 48h postoperatively | total amount of morphine used for analgesia | 1st 48 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural, morphine, midazolam, acute postoperative pain