Combined Epidural Morphine and Midazolam on Postoperative Pain

Phase 1

• Conditions: Acute Postoperative Pain
• Interventions: Drug: midazolam

• Registration Number: NCT04033471
• Lead Sponsor: Assiut University

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

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-26
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24
• Primary Completion: 2021-03
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MI	midazolam	Bupivacaine 0.25% + midazolam 5mg in total volume 10m1
MM	midazolam	Bupivacaine 0.25% + midazolam 5mg and morphine 5mg in total volume 10ml
MO	midazolam	bupivacaine 0.25% + morphine 5 mg in total volume 10 ml

Primary Outcome Measures

Name	Time	Method
time to first request of analgesia	1st 48 hours postoperative	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

Name	Time	Method
the cumulative consumption of morphine in the 1st 48h postoperatively	1st 48 hours postoperative	total amount of morphine used for analgesia

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt