Effects of Methylprednisolone Plus Ropivacaine Infiltration Before Wound Closure on Laminoplasty or Laminectomy
Condition: Postoperative Pain; Neurosurgery
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): Methylprednisolone 40 mg + Ropivacaine + Saline; Ropivacaine + Saline
Intervention type(s): Drug; Drug
Intervention description(s): To infiltrate the study solution, the surgeon will inject the incision site with a 10 cm long, 22-gauge needle before the closing of the incision site. A standard volume of 10 ml in each level will be injected, based on the study by Milligan et al., with a total of 5ml study solution injected laterally into the erector spinae muscle and 5 ml subcutaneously along both margins of the incision. This standardization will be on the basis of the number of levels to be treated, and will be consistent in each patient. The depth of penetration will include the subcutaneous tissues, paravertebral muscles, along with the deep muscles surrounding the spinous process, lamina, transverse process and facet joints; the epidural space and intrathecal space will be spared. The local infiltration solution in the treatment group will consist of a total of 30 ml study solution, containing 1 ml of 40 mg methylprednisolone plus 15ml of 1% ropivacaine and 14 ml saline.; To infiltrate the study solution, the surgeon will inject the incision site with a 10 cm long, 22-gauge needle before the closing of the incision site. A standard volume of 10 ml in each level will be injected, based on the study by Milligan et al., with a total of 5ml study solution injected laterally into the erector spinae muscle and 5 ml subcutaneously along both margins of the incision. This standardization will be on the basis of the number of levels to be treated, and will be consistent in each patient. The depth of penetration will include the subcutaneous tissues, paravertebral muscles, along with the deep muscles surrounding the spinous process, lamina, transverse process and facet joints; the epidural space and intrathecal space will be spared. The local infiltration solution in the control group will consist of a total of 30 ml study solution, containing 15 ml of 1% ropivacaine and 15ml saline.
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Ropivacaine; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative Pain; Methylprednisolone; Ropivacaine; Local Infiltration; Laminoplasty; Laminectomy