Combined Epidural Morphine and Midazolam on Postoperative Pain

NCT04033471 | Unknown Phase 1

• 1 other identifier: 464
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Postoperative Pain

Keywords

epidural, morphine, midazolam, acute postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the cumulative consumption of morphine in the 1st 48h postoperatively

  1st 48 hours postoperative

Study Arms (3)

MI

ACTIVE COMPARATOR

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

Drug: midazolam

MM

ACTIVE COMPARATOR

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

Drug: midazolam

MO

ACTIVE COMPARATOR

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

Drug: midazolam

Interventions

midazolam 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

Also known as: morphine, bupivacaine

MI; MM; MO

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II patients scheduled for major abdominal cancer surgeries

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 171516, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Midazolam; Morphine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Shereen M Kamal, Associate proferssor

CONTACT

01006279209; sheridouh79@yahoo.com

Khaled M Fares, proferssor

CONTACT

01289757288; faressali@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of anesthesia, ICU and pain manegement

Model Details: epidural bupiviacain

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 26, 2019
• Study Start: July 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

EG (1)