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

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
intraperitoneal levobupivacaine and morphine
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ‪Khalid abdelal‬

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

levobupivacaine with morphine

levobupivacaine with magnesium sulfate

Arm Description

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

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

Outcomes

Primary Outcome Measures

reduction of postoperative pain
reduction of post operative visual analogue score

Secondary Outcome Measures

Full Information

First Posted
March 6, 2022
Last Updated
March 6, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05281081
Brief Title
Intraperitoneal Instillation of Levobupivacaine With Morphine Versus Levobupivacaine With Magnesium Sulfate for Postoperative Analgesia
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
levobupivacaine with morphine
Arm Type
Active Comparator
Arm Description
30 patients will have intraperitoneal instillation of levobupivacaine with added morphine at the end of laparoscopic cholecystectomy operation
Arm Title
levobupivacaine with magnesium sulfate
Arm Type
Experimental
Arm Description
30 patients will have intraperitoneal instillation of levobupivacaine with added magnesium sulfate at the end of laparoscopic cholecystectomy operation
Intervention Type
Drug
Intervention Name(s)
intraperitoneal levobupivacaine and morphine
Intervention Description
istillation of the peritoneum with levobupivacaine mixture with morphine
Primary Outcome Measure Information:
Title
reduction of postoperative pain
Description
reduction of post operative visual analogue score
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
‪Khalid abdelal‬
City
Sohag
ZIP/Postal Code
532
Country
Egypt

12. IPD Sharing Statement

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

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