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

Phase 4

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: intraperitoneal levobupivacaine and morphine

• Registration Number: NCT05281081
• Lead Sponsor: Sohag University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-12-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-06
• Study First Submitted QC: 2022-03-06
• Last Update Submitted: 2022-03-06
• Study First Posted: 2022-03-15
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
levobupivacaine with morphine	intraperitoneal levobupivacaine and morphine	30 patients will have intraperitoneal instillation of levobupivacaine with added morphine at the end of laparoscopic cholecystectomy operation
levobupivacaine with magnesium sulfate	intraperitoneal levobupivacaine and morphine	30 patients will have intraperitoneal instillation of levobupivacaine with added magnesium sulfate at the end of laparoscopic cholecystectomy operation

Primary Outcome Measures

Name	Time	Method
reduction of postoperative pain	8 hours	reduction of post operative visual analogue score

Trial Locations

Locations (1)

‪Khalid abdelal‬; 🇪🇬 Sohag, Egypt