The efficacy of bilateral intervertebral foramen block for pain management in percutaneous endoscopic lumbar discectomy: A protocol for randomized controlled trial

BACKGROUND: Compared with open lumbar microdiscectomy, percutaneous endoscopic lumbar discectomy (PELD) has the advantages of remarkable preservation of paravertebral structures, less bleeding, shorter operation time and fewer complications, it is a common method for the treatment of lumbar disc herniation (LDH). Local anesthesia is recommended during PELD. However, intraoperative pain is sometimes difficult to control satisfactorily. The efficacy of bilateral intervertebral foramen block (IFB) for pain management in PELD remains unclear. Therefore, this regimen is utilized in a randomized controlled trial for the assessment the safety and effectiveness of bilateral IFB for PELD pain control. METHOD: This is a single center and randomized controlled trial which will be implemented from September 2020 to September 2021. This research protocol is in accordance with the items of the Standard Protocol for Randomized Trials, which was authorized through the Ethics Committee of Huzhou Central Hospital & Affiliated Centre Hospital of Huzhou University (HZCH0465-0864). 100 participants who undergo PELD will be analyzed. Inclusion criteria contains: 1. patients diagnosed with LDH undergoing PELD; 2. people between the ages of 18 and 75; 3. consistent imaging evidence of herniation at a same level (CT or MRI); 4. receive conservative treatment for 2 months. The exclusion criteria contains: 1. patients with the history of severe renal and hepatic dysfunction; 2. more than 1 responsible level; 3. LDH combined with other spinal diseases needing advanced surgical treatment (such as fracture, spondylolisthesis, lumbar spinal stenosis, tumor, etc.); 4. Patients have mental illness that will prevent their willingness to participate in the study. Patients will be randomly divided into bilateral IFB group (with 50 patients) and local infiltration analgesia group (with 50 patients). Primary outcomes are pain score at different time points. The secondary outcomes are the operative time, radiation exposure time, length of hospital stay and postoperative complications. All the analysis is implemented through applying the IBM SPSS Statistics for Windows, version 20 (IBM Corp., Armonk, NY, USA). RESULTS: The clinical outcome variables between groups are illustrated in the Table 1. CONCLUSION: This investigation can offer a reliable basis for the effectiveness and safety of IFB in treating the PELD pain. TRIAL REGISTRATION: This study protocol is registered in Research Registry (researchregistry5985).