Analgesia Following Lumbar Discectomy

June 27, 2026 updated by: Zagazig University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Yasser Nasr, MD
  • Phone Number: 01223417403

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Zagazig University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Retrolaminar block group
After confirming the correct position using imaging with a C-Arm device, the patient will receive a retrolaminar block on both sides at the level of the operated disc.
Procedure: Retrolaminar plane block
Retrolaminar plane infiltration with the local anesthetic mixture.
Active Comparator: Local Infiltration group
The patient will receive local wound infiltration following the completion of the surgical steps with the patient in the prone position using a local anesthetic solution, tailored to the specific conditions surrounding the incision site.
Procedure: Local wound infiltration
Local infiltration along the surgical incision.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The first 24 hours postoperative.
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.
The first 24 hours postoperative.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
The first 24 hours postoperative.
Duration of the surgical intervention.
Time Frame: The first 2 hours.
Duration of surgery in minutes.
The first 2 hours.
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 .
At the end of the first 24 hours postoperative.
Total amount of opioid consumption
Time Frame: The first 24 hours postoperative.
The total opioid consumption within the first 24 hours postoperative.
The first 24 hours postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zagazig University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yasser Mohamed Nasr, MD, Department of Anesthesia, Intensive Care & Pain Management, Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Spine surgeries Analgesia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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