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Clinical Trials/NCT06662318
NCT06662318
Completed
N/A

Perioperative Analgesic Manipulations to Mitigate Pain After Elective Lumbar Spinal Surgeries: A Prospective Case-controlled Study

Benha University1 site in 1 country75 target enrollmentOctober 1, 2024

Overview

Phase
N/A
Intervention
Lidocaine Hydrochloride
Conditions
Pain, Postoperative
Sponsor
Benha University
Enrollment
75
Locations
1
Primary Endpoint
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Lumbar Spine Surgery.
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

Perioperative pain management is crucial for patients undergoing elective lumbar spine surgery. Moderate to severe postoperative pain can significantly impact recovery, worsen patient outcomes, and potentially lead to chronic pain.

Opioids have traditionally been the mainstay of postoperative pain management. However, their use is associated with several adverse effects, including nausea, vomiting, respiratory depression, and the risk of developing chronic pain. To mitigate these risks, there is a growing emphasis on multimodal analgesic approaches that combine various non-opioid medications to provide effective pain relief.

Non-opioid analgesics, such as nonsteroidal anti-inflammatory drugs (NSAIDs), regional anesthesia techniques, and adjuvant medications, can be used to reduce opioid requirements and improve patient outcomes. By carefully selecting and combining these modalities, clinicians can optimize pain management strategies for individual patients, minimizing the need for opioids and their associated side effects.

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
January 15, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Azza Mahrous Shaffik

Clinical Lecturer of Anesthesia, Pain & ICU

Benha University

Eligibility Criteria

Inclusion Criteria

  • Patients who had LDD and required lumbar discectomy,
  • Patients are free of exclusion criteria and accepted to participate in the study.

Exclusion Criteria

  • The presence of other indications for spinal surgery;
  • Obesity of grade ≥II;
  • Patients of ASA grade \>II;
  • opioid dependence for preoperative pain;
  • The presence of other causes of preoperative pain;
  • The presence of preoperative psychiatric manifestations especially delirium and/or cognitive dysfunction;
  • The presence of contraindications for the use of the study drugs;
  • The presence of uncontrolled cardiac, renal, or hepatic disorders and essential hypertension.

Arms & Interventions

Group L

Intervention: Lidocaine Hydrochloride

Group D

Intervention: Dexmedetomidine

Group F

Intervention: Fentanyl Citrate

Outcomes

Primary Outcomes

Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Lumbar Spine Surgery.

Time Frame: 2 months

Value of non-opioid injection in Pain Reduction post operatively manifested by recurrence of pain.

Study Sites (1)

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