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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04630938
Other study ID # 17300478
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 24, 2020
Est. completion date October 30, 2021

Study information

Verified date February 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

undertake confidently both open and laparoscopic cholecystectomy. Major types of body injuries surgical or accidental; evoke a temporary, yet predictable systemic inflammatory response caused by hormonal, immunological and metabolic mediators. This inflammatory response is essential for tissue repair and has evolved to maximize the organisms' healing potential. In healthy individuals the inflammatory response to major surgery is well balanced consisting of pro- and anti-inflammatory mediators. The severity of injury, the occurrence of surgical complications and its accompanying level of stress may hinder the balance of the inflammatory response6.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date October 30, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Adult patients aging 18 - 55 years old - Patients scheduled for abdominal surgeries - Patients with American Society of Anesthesiologists (ASA) I, II physical status Exclusion Criteria: - Patients' refusal. - Critically ill patients. - Patients who have contraindications to regional anesthesia.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Morphine Sulfate
intrathecal morphine will be added to anaesthetics
morphine+lidocaine
local anesthetic will be infused intravenously
Saline
intravenous saline infusion

Locations

Country Name City State
Egypt Esam A. Hamed Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analogue score a scale to measure pain intensity graded from 0 = no pain to 10 = worst pain 24 hours
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