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Active, Not Recruiting

NCT Number: NCT06869889

Analgesia Following Lumbar Discectomy

Lumbar discectomy surgeries are often the last option for patients with disc herniation who do not improve with conservative treatments. However, these procedures can lead to significant perioperative pain that may become chronic without effective management. While intravenous opioids are commonly used for pain control, they can complicate recovery and pose risks like dependence. In contrast, regional anesthetic techniques offer advantages such as quicker recovery, better postoperative pain relief, and reduced opioid use, which can lead to shorter hospital stays. Our study aims to compare the effectiveness of the retrolaminar block with local wound infiltration for pain management following posterior lumbar discectomy surgeries, potentially improving patient outcomes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Analgesia Agnosia Disk Herniated Lumbar Local Infiltration Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig university hospital

Zagazig, Egypt

About this study

Lumbar discectomy surgeries are the last resort for disc herniation patients not responding to conservative treatment. However, these surgeries are associated with annoying perioperative pain that could be severe and progress to chronic pain if not managed properly. There is no consensus regarding the best approach for postoperative pain management following spine surgeries. Intravenous opioids are still the primary agents used for perioperative pain control, which can complicate the postoperative recovery with the associated side effects and the risk of opioid dependence. Regional anesthetic techniques for spine surgeries allow rapid recovery, prolonged postoperative analgesia, and less opioid consumption, which decreases hospital stays. The current study will compare the analgesic efficacy of the retrolaminar block to the local wound infiltration following posterior lumbar discectomy surgeries.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective surgical decompression of single-level herniated lumbar disc.

Exclusion criteria

  • Opioid-dependent patients.
  • Known hypersensitivity to bupivacaine.
  • Diabetic patients.
  • Uncooperative patient or with altered mental status.
  • Previous spine surgery.

Treatment and study plan

Retrolaminar plane block

Procedure

Retrolaminar plane infiltration with the local anesthetic mixture.

Local wound infiltration

Procedure

Local infiltration along the surgical incision.

Primary outcomes

  1. Number of patients who required rescue analgesia

    Time frame: The first 24 hours postoperative.

    The percentage of patients who required rescue analgesia within the first 24 hours.

  2. The time to first rescue analgesia

    Time frame: The first 24 hours postoperative.

    The time to first rescue analgesic request within the first 24 hours postoperative.

Secondary outcomes

  1. The Numerical Pain Rating Scale

    Time frame: The first 24 hours postoperative.

    On a scale of 0-10, the patient will be asked to classify postoperative pain as the following 0: no pain, and 10: maximum imaginable pain. Postoperative pain will be assessed at 1,2,4,6,12,18, and 24 hours postoperative.

  2. Total amount of opioid consumption

    Time frame: The first 24 hours postoperative.

    The total opioid consumption within the first 24 hours postoperative.

  3. Duration of the surgical intervention.

    Time frame: The first 2 hours.

    Duration of surgery in minutes.

  4. Patient satisfaction (quality of life questionnaire)

    Time frame: At the end of the first 24 hours postoperative.

    Patient satisfaction will be assessed using a 7-point Likert-like verbal rating scale. The patient will be asked to express their level of satisfaction 24 hours after the procedure, using the following scale: 1 = extremely dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neutral, 5 = somewhat satisfied, 6 = satisfied, and 7 = extremely satisfied .

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Fluoroscopy-Guided Retrolaminar Block Versus Local Wound Infiltration for Post Lumbar Discectomy Analgesia: A Double-Blinded, Randomized Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Jul 1, 2026

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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