Clinical trial NCT06869889: Analgesia Following Lumbar Discectomy
Official title: Fluoroscopy-Guided Retrolaminar Block Versus Local Wound Infiltration for Post Lumbar Discectomy Analgesia: A Double-Blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Disk Herniated Lumbar
Local Infiltration
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-03-11
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients who required rescue analgesia
timeFrame: The first 24 hours postoperative.
measure: Total amount of opioid consumption
timeFrame: The first 24 hours postoperative.
Secondary outcomes:
measure: The Numerical Pain Rating Scale
timeFrame: The first 24 hours postoperative.
measure: Duration of the surgical intervention.
timeFrame: The first 2 hours.
measure: Patient satisfaction (quality of life questionnaire)
timeFrame: At the end of the first 24 hours postoperative.
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university hospital
Study officials:
affiliation: Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
name: Yasser Mohamed Nasr, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.