Perioperative Pain Management for Lumbar Spine Surgery

NCT06662318 | Completed

• 1 other identifier: RC 22/10/2024
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

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 for Lumbar Spine Surgery.

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

  2 months

Study Arms (3)

Group L

ACTIVE COMPARATOR

Drug: Lidocaine Hydrochloride

Group D

ACTIVE COMPARATOR

Drug: Dexmedetomidine

Group F

ACTIVE COMPARATOR

Drug: Fentanyl Citrate

Interventions

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.

Group F

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.

Group D

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.

Group L

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who had LDD and required lumbar discectomy,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, El Qalyoubia, 13511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl; Dexmedetomidine; Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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: Clinical Lecturer of Anesthesia, Pain & ICU

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: October 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 15, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

EG (1)