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Status unknownNCT04033471Updated Feb 24, 2021

Combined Epidural Morphine and Midazolam on Postoperative Pain

A Phase 1/2 interventional study of midazolam in Acute Postoperative Pain, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-24.

Sponsored by Assiut University · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

this study aim to Compare the effect of preoperative Epidural Midazolam, Morphine and their combination in postoperative pain relief and total morphine consumption.

Read the 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

02

Conditions studied

  • Acute Postoperative Pain

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Keywords

  • epidural, morphine, midazolam, acute postoperative pain
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 20 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    MI

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

    Drug: midazolam

  • Active comparator
    MM

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

    Drug: midazolam

  • Active comparator
    MO

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

    Drug: midazolam

Interventions

  • Drugmidazolam

    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

06

What researchers measure

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

    Time frame: 1st 48 hours postoperative

Secondary outcomes

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

    total amount of morphine used for analgesia

    Time frame: 1st 48 hours postoperative

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04033471
Lead sponsor
Assiut University
Responsible party
Shereen Mamdouh (associate professor of anesthesia, ICU and pain manegement, Assiut University) — Principal investigator
First posted
Jul 26, 2019
Start date
Jul 1, 2019
Primary completion
Mar 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
Feb 24, 2021

Study contacts

Shereen M Kamal, Associate proferssor
Contact
sheridouh79@yahoo.com
01006279209
Khaled M Fares, proferssor
Contact
faressali@yahoo.com
01289757288

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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