AnalgesiaNCT06869889
Analgesia Following Lumbar Discectomy
A study testing Retrolaminar plane block and Local wound infiltration in people with Analgesia and Disk Herniated Lumbar, run by Zagazig University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Analgesia, Disk Herniated Lumbar, Local Infiltration
- What is being tested?
- Retrolaminar plane block and Local wound infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Elective surgical decompression of single-level herniated lumbar disc.
Who cannot join
- Opioid-dependent patients.
- Known hypersensitivity to bupivacaine.
- Diabetic patients.
- Uncooperative patient or with altered mental status.
- Previous spine surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Analgesia, Disk Herniated Lumbar, Local Infiltration
- Being tested
- Retrolaminar plane block, Local wound infiltration
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrolaminar plane blockProcedure or surgery
Retrolaminar plane infiltration with the local anesthetic mixture.
Local wound infiltrationProcedure or surgery
Local infiltration along the surgical incision.
| Study group | Role | What they receive |
|---|---|---|
| Retrolaminar block group | Active comparator | 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. Receives: Procedure: Retrolaminar plane block |
| Local Infiltration group | Active comparator | 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. Receives: Procedure: Local wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who required rescue analgesia
The percentage of patients who required rescue analgesia within the first 24 hours.
Measured: The first 24 hours postoperative.
The time to first rescue analgesia
The time to first rescue analgesic request within the first 24 hours postoperative.
Measured: The first 24 hours postoperative.
Secondary outcomes (4)
The Numerical Pain Rating Scale
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.
Measured: The first 24 hours postoperative.
Total amount of opioid consumption
The total opioid consumption within the first 24 hours postoperative.
Measured: The first 24 hours postoperative.
Duration of the surgical intervention.
Duration of surgery in minutes.
Measured: The first 2 hours.
Patient satisfaction (quality of life questionnaire)
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 .
Measured: At the end of the first 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start12 Mar 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yasser Mohamed Nasr, MD, Study director, Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869889
- Sponsor's protocol ID
- Spine surgeries Analgesia
- Status last verified
- Sep 2025
- First submitted
- 25 Feb 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 38034203Prabhakar 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.
PubMed 35528286Tao 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.
PubMed 31270055Liu 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.
PubMed 33574697
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroscopy-Guided Retrolaminar Block Versus Local Wound Infiltration for Post Lumbar Discectomy Analgesia: A Double-Blinded, Randomized Trial
- ClinicalTrials.gov ID
- NCT06869889
- Acronym / sponsor ID
- Spine surgeries Analgesia
- Conditions
- Analgesia, Disk Herniated Lumbar, Local Infiltration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrolaminar block group | Active comparator | Procedure: Retrolaminar plane blockAfter 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. |
| Local Infiltration group | Active comparator | Procedure: Local wound infiltrationThe 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. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Elective surgical decompression of single-level herniated lumbar disc.
Key exclusion criteria (5 listed)
- Opioid-dependent patients.
- Known hypersensitivity to bupivacaine.
- Diabetic patients.
- Uncooperative patient or with altered mental status.
- Previous spine surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrolaminar plane blockRetrolaminar plane infiltration with the local anesthetic mixture. | Procedure or surgery | Retrolaminar block group |
| Local wound infiltrationLocal infiltration along the surgical incision. | Procedure or surgery | Local Infiltration group |
Primary outcome
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 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.
4 secondary outcomes
The Numerical Pain Rating Scale
Time frame: The first 24 hours postoperative.
Total amount of opioid consumption
Time frame: The first 24 hours postoperative.
Duration of the surgical intervention.
Time frame: The first 2 hours.
Patient satisfaction (quality of life questionnaire)
Time frame: At the end of the first 24 hours postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 38034203Awadalla 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.
- Background: PubMed 35528286Prabhakar 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.
- Background: PubMed 31270055Tao 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.
- Background: PubMed 33574697Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasser Mohamed Nasr, MD study director
Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrolaminar plane block and Local wound infiltration in people with Analgesia and Disk Herniated Lumbar, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who required rescue analgesia (time frame: The first 24 hours postoperative.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06869889, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.