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OpenTrials
Completed

NCT Number: NCT06662318

Perioperative Pain Management for Lumbar Spine Surgery

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.

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Key information

Conditions

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

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, El Qalyoubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fentanyl Citrate

Drug

Fentanyl was given as a bolus of 1 µg/kg injected followed by a fentanyl infusion of 0.4 µg/kg/h. Fentanyl infusion was continued as Postoperative analgesia for 24 hours in a dose of 0.3 µg/kg/h.

Dexmedetomidine

Drug

Dexmedetomidine was given as a loading dose of 0.6 µg/kg, which was diluted to a total volume of 10 cc of normal saline and injected before induction of anesthesia over 10 minutes. Then, a DXM infusion prepared to provide 0.2-0.7 µg/kg/h was started Intraoperative; Postoperative DXM infusion was provided in a dose of 0.15 µg/kg/h for 24-h.

Lidocaine Hydrochloride

Drug

Lidocaine hydrochloride was provided as 2 mg/kg slowly IV before induction of anesthesia and as an IV infusion at a rate of 3 mg/kg/h. Postoprative lidocaine infusion at a dose of 1.5 mg/kg/h was administered for 24 Postoprative hours.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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