Efficient Postoperative Pain Management With Multimodal IV

NCT06661746 | Completed

• 1 other identifier: Rc 1-7-2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Multimodal Group

ACTIVE COMPARATOR

Drug: Multimodal IV analgesia

Epidural Group

ACTIVE COMPARATOR

Drug: epidural analgesia

Interventions

Multimodal IV analgesia DRUG

Multimodal IV analgesia of lidocaine, ketamine and MS

Multimodal Group

epidural analgesia DRUG

Opioid-based and epidural analgesia

Epidural Group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, El Qalyoubia, 13511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Pain & ICU

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: July 15, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 15, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Locations

EG (1)