Effects of Methylprednisolone Plus Ropivacaine Infiltration Before Wound Closure on Laminoplasty or Laminectomy

Capital Medical University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Neurosurgery

Treatments: Drug: Methylprednisolone 40 mg + Ropivacaine + Saline; Drug: Ropivacaine + Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04493463

KY 2019-112-02-2

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 2 patient groups

methylprednisolone + ropivacaine + saline

Experimental group

Description:

The local infiltration solution in the methylprednisolone plus ropivacaine with saline group (treatment group) will consist of 1 ml of 40 mg methylprednisolone plus 15ml of 1% ropivacaine and 14 ml saline.

Treatment:

Drug: Methylprednisolone 40 mg + Ropivacaine + Saline

ropivacaine + saline

Active Comparator group

Description:

The local infiltration solution in the ropivacaine plus saline group (control group) will consist of 15 ml of 1% ropivacaine and 15ml saline.

Treatment:

Drug: Ropivacaine + Saline