Efficient Postoperative Pain Management With Multimodal IV

December 19, 2024 updated by: Eman M Elafifi, Benha University

Multimodal Intravenous Analgesia Using Half-dose of Ketamine, Lidocaine and Magnesium Sulfate Provides Efficient Postoperative Analgesia for Patients Undergoing Major Abdominal Surgery: Randomized, Case-controlled Study

Postoperative pain remains a prevalent concern despite ongoing improvements in surgical methods and pain management strategies. Opioids, while commonly prescribed, frequently lead to undesirable side effects. Epidural analgesia, though a viable option, carries its risks and complications. Recent research indicates that combining intravenous lidocaine and ketamine can significantly alleviate postoperative pain and decrease the reliance on opioids within the initial 24 hours following surgery. This approach offers a promising alternative with minimal additional adverse effects, suggesting a potential shift in pain management practices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Qalyoubia
      • Banhā, El Qalyoubia, Egypt, 13511
        • Benha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients were assigned for surgical intervention;
  • Patients of ASA grade I-III;
  • Patients were free of exclusion criteria;

Exclusion Criteria:

  • Patients who are not in ASA grade I-III;
  • Patients who had uncontrolled hypertension and/or diabetes mellitus;
  • Patients who had uncompensated cardiac, renal, or hepatic diseases;
  • Patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs;
  • Patients who refused to sign the informed consent were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Multimodal Group
Drug: Multimodal IV analgesia
Multimodal IV analgesia of lidocaine, ketamine and MS
Active Comparator: Epidural Group
Drug: epidural analgesia
Opioid-based and epidural analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative follow up.
Time Frame: 3 months
Value of Multimodal injection in Pain Reduction post operatively manifested by recurrence of pain.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2024

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

November 15, 2024

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 19, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rc 1-7-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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