Effects of Methylprednisolone Plus Ropivacaine Infiltration Before Wound Closure on Laminoplasty or Laminectomy
Status:
Completed
Trial end date:
2021-05-06
Target enrollment:
Participant gender:
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.