Efficient Postoperative Pain Management With Multimodal IV

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: Post Operative Pain
• Intervention / Treatment: Drug: Multimodal IV analgesia; Drug: epidural analgesia

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	Value of Multimodal injection in Pain Reduction post operatively manifested by recurrence of pain.	3 months

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

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: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• 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