Clinical trial NCT04493463: Effects of Methylprednisolone Plus Ropivacaine Infiltration Before Wound Closure on Laminoplasty or Laminectomy
Official title: Effects of Methylprednisolone Plus Ropivacaine Infiltration Before Wound Closure on Laminoplasty or Laminectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Neurosurgery
Keywords: Postoperative Pain
Methylprednisolone
Ropivacaine
Local Infiltration
Laminoplasty
Laminectomy
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Laminoplasty and laminectomy are useful surgical procedures for the management of various conditions pertaining the spinal cord such as myelopathy, radiculopathy, neoplasm, stenosis, disc herniation, hematoma, abscess, traumatic injuries, etc. Both are generally effective procedures that decompress the spinal cord by expanding the space available for the spinal cord. Both procedures provide good neural decompression and functional improvement after surgery, thereby preventing catastrophic cord injury. However, patients undergoing these procedures experience severe pain in the postoperative period; this may lead to the increase in postoperative morbidity and complications. Suboptimal analgesic therapy causes discomfort to the patient and could increase the incidence of postoperative complications, prolong hospital stay and increase health expenses. The extensive exposure to multiple levels in spine surgeries lead to postoperative pain caused by muscular dissection and requires adequate pain relief to hasten rehabilitation, so that the incidence of chronic pain is significantly decreased. This pain is usually treated with intramuscular, epidural or IV-PCA (Intravenous- Patient Controlled Analgesia) opioids. Several oral analgesics, intermittent intravenous and intramuscular injections and PCA with several systemic side effects, have long been used for the control of postoperative pain. In 1953, Lewis et al. established that local infiltration is a reliable pain relief technique for postoperative pain, with the advantages of safety, simplicity and low cost. The intraoperative injection of 40 mg of methylprednisolone via the intra-buccal approach into the masseter muscle has found to have significantly reduced swelling, trismus and postoperative pain associated with the surgical extraction of impacted lower third molars. A single, preoperative dose of Methylprednisolone 125 mg IV before Total Knee Arthroplasty led to improvement of postoperative analgesia and immediate recovery, when combined with an extensive, multimodal oral and local infiltration analgesic regime. Preemptive administration of bupivacaine or bupivacaine plus methylprednisolone to the paravertebral muscles in patients undergoing lumbar discectomy has been proved to provide effective analgesia in the early postoperative period, when compared to patients who received no local anesthetic or steroid. The infiltration of levobupivacaine and bupivacaine plus methylprednisolone in single distance-single site, lumbar disc surgery established that postoperative analgesic requirement was significantly lower and the first analgesia demand time was also significantly later in the local anesthesia plus methylprednisolone group, compared to the control group. A randomized controlled trial of a larger scale, with a longer follow-up period, could provide a more significant data. Therefore this study has been designed as a prospective, randomized, open-label, blinded endpoint (PROBE) study with a 1 month follow-up period, to compare the efficacy of methylprednisolone plus ropivacaine versus ropivacaine alone, administered before wound closure, for providing analgesia after laminoplasty and laminectomy.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for laminoplasty or laminectomy under general anesthesia
* American Society of Anesthesiologists (ASA) classification I or II
* Age 18 to 64 years

Exclusion Criteria:

* Patient refusal
* Inability to give written informed consent
* Participants who cannot use a patient-controlled analgesia (PCA) device and cannot understand the instructions of a Visual Analogue Score (VAS)
* Previous history of spinal surgery
* Allergy to opioids, methylprednisolone or ropivacaine
* Peri-incisional infection
* History of stroke or a major neurological deficit
* Trauma, deformity
* Psychological problems
* Extreme body mass index (BMI) (\< 15 or \> 35)
* History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects
* Patients using systemic steroids
* Pregnant or breastfeeding;
* Preoperative Glasgow Coma Scale \< 15
* Participants who have received radiation therapy or chemotherapy preoperatively, or a high probability to require a postoperative radiation therapy or chemotherapy according to the preoperative imaging

Primary outcomes:
measure: The primary outcome will be the cumulative sufentanil dose during the 48 hours after surgery via the PCA device.
timeFrame: Within 48 hours after the surgery
Secondary outcomes:
measure: Visual Analogue Score
timeFrame: 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks and 4 weeks after surgery
measure: Cumulative sufentanil dose for four separate periods
timeFrame: 0-4, 4-8, 8-24, and 24-48 hours
measure: First analgesia demand on the PCA device
timeFrame: Within 48 hours postoperatively
measure: Patient Satisfaction Score
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks and 4 weeks postoperatively
measure: Postoperative Nausea and Vomiting
timeFrame: 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
measure: Ramsay Sedation Scale
timeFrame: 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
measure: The World Health Organization Quality of Life-BREF scores
timeFrame: 4 weeks after surgery
measure: Oswestry Disability Index
timeFrame: Preoperatively and at 4 weeks postoperatively
measure: Patient Scar Assessment and the Observer Scar Assessment Scale
timeFrame: 4 weeks postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References:
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