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NCT05281081 Clinical Trial

Intraperitoneal Instillation of Levobupivacaine With Morphine Versus Levobupivacaine With Magnesium Sulfate for Postoperative Analgesia

Post Operative Pain Clinical Trial

Official title:
Comparison of Intra-Peritoneal Instillation of Levobupivacaine With Morphine Hydrochloride Versus Levobupivacaine With Magnesium Sulfate for Post-Operative Pain Relief After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05281081
Other study ID # Soh-Med-22-02-27
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2021
Est. completion date December 1, 2021

Study information
Verified date March 2022
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective randomized study that included 60 patients and was divided into two equal groups of patients who were scheduled for LC, Ages 18 and 60 years, both sexes, ASA I-II and BMI 19 - 39. Group A received 30 ml levobupivacaine (0.25%) plus 3 mg morphine intraperitoneal at the site of surgery in the bed of the gallbladder via the navel port with the patient in a Trendelenburg position, Group B received 30 ml levobupivacaine (0.25%) plus 50 mg/kg magnesium sulfate in the same pattern as in the A group.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Patients who were scheduled for L.C, - Ages 18 and 60 years - ASA I-II and - BMI 19 - 39 Exclusion Criteria: - Patients with hepatic or renal dysfunction - use of opioids 24 hrs prior to the study - treatment with steroids prior to surgery - drug or alcohol abuse, allergy to any of the study drugs - chronic pain syndrome as a result of neurological disease

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• intraperitoneal levobupivacaine and morphine
istillation of the peritoneum with levobupivacaine mixture with morphine

Locations
Country Name City State
Egypt ?Khalid abdelal? Sohag

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary reduction of postoperative pain reduction of post operative visual analogue score 8 hours
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