Combined Epidural Morphine and Midazolam on Postoperative Pain

Acute Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04033471
• Other study ID #: 464
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2019
• Est. completion date: April 2021

Study information

• Verified date: February 2021
• Source: Assiut University
• Contact: Shereen M Kamal, Associate proferssor
• Phone: 01006279209
• Email: sheridouh79[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Postoperative Pain
• Pain, Postoperative

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the cumulative consumption of morphine in the 1st 48h postoperatively	total amount of morphine used for analgesia	1st 48 hours postoperative