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

NCT05281081 | Completed Phase 4

• 1 other identifier: Soh-Med-22-02-27
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• reduction of postoperative pain

  reduction of post operative visual analogue score

  8 hours

Study Arms (2)

levobupivacaine with morphine

ACTIVE COMPARATOR

30 patients will have intraperitoneal instillation of levobupivacaine with added morphine at the end of laparoscopic cholecystectomy operation

Drug: intraperitoneal levobupivacaine and morphine

levobupivacaine with magnesium sulfate

EXPERIMENTAL

30 patients will have intraperitoneal instillation of levobupivacaine with added magnesium sulfate at the end of laparoscopic cholecystectomy operation

Drug: intraperitoneal levobupivacaine and morphine

Interventions

intraperitoneal levobupivacaine and morphine DRUG

istillation of the peritoneum with levobupivacaine mixture with morphine

levobupivacaine with magnesium sulfate; levobupivacaine with morphine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who were scheduled for L.C,
• Ages 18 and 60 years
• ASA I-II and
• BMI 19 - 39

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

‪Khalid abdelal‬

Sohag, 532, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 15, 2022
• Study Start: January 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

EG (1)