Perioperative Pain Management for Lumbar Spine Surgery

Not Applicable

Recruiting

• Conditions: Pain, Postoperative
• Interventions: Drug: Lidocaine Hydrochloride; Drug: Dexmedetomidine; Drug: Fentanyl Citrate

• Registration Number: NCT06662318
• Lead Sponsor: Benha University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-01
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L	Lidocaine Hydrochloride	-
Group D	Dexmedetomidine	-
Group F	Fentanyl Citrate	-

Primary Outcome Measures

Name	Time	Method
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.	2 months	Value of non-opioid injection in Pain Reduction post operatively manifested by recurrence of pain.

Trial Locations

Locations (1)

Benha University; 🇪🇬 Banhā, El Qalyoubia, Egypt