- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06869889
Analgesia Following Lumbar Discectomy
April 30, 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
Active, not recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
130
Phase
- 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 Locations
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
Local infiltration along the surgical incision.
|
What is the study measuring?
Primary Outcome Measures
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.
|
|
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.
|
Secondary Outcome Measures
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
- Awadalla AM, Aljulayfi AS, Alrowaili AR, Souror H, Alowid F, Mahdi AMM, Hussain R, Alzahrani MM, Alsamarh AN, Alkhaldi EA, Alanazi RC. Management of Lumbar Disc Herniation: A Systematic Review. Cureus. 2023 Oct 29;15(10):e47908. doi: 10.7759/cureus.47908. eCollection 2023 Oct.
- Prabhakar NK, Chadwick AL, Nwaneshiudu C, Aggarwal A, Salmasi V, Lii TR, Hah JM. Management of Postoperative Pain in Patients Following Spine Surgery: A Narrative Review. Int J Gen Med. 2022 May 2;15:4535-4549. doi: 10.2147/IJGM.S292698. eCollection 2022.
- Tao T, Zhou Q. [Efficacy of erector spinae block versus retrolaminar block for postoperative analgesia following posterior lumbar surgery]. Nan Fang Yi Ke Da Xue Xue Bao. 2019 Jun 30;39(6):736-739. doi: 10.12122/j.issn.1673-4254.2019.06.17. Chinese.
- Liu D, Xu X, Zhu Y, Liu X, Zhao F, Liang G, Zhu Z. Safety and Efficacy of Ultrasound-Guided Retrolaminar Block of Multiple Injections in Retroperitoneal Laparoscopic Nephrectomy: A Prospective Randomized Controlled Study. J Pain Res. 2021 Feb 5;14:333-342. doi: 10.2147/JPR.S282500. eCollection 2021.
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)
March 12, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
February 25, 2025
First Submitted That Met QC Criteria
March 10, 2025
First Posted (Actual)
March 11, 2025
Study Record Updates
Last Update Posted (Actual)
May 6, 2026
Last Update Submitted That Met QC Criteria
April 30, 2026
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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