Preemptive Infiltration With Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy
Condition: Pain, Postoperative; Neurosurgery
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Laminoplasty and laminectomy have been used for decades for the treatment of intraspinal
      space occupying lesions, spinal stenosis, disc herniation, injuries, etc. After these
      procedures, patients often experience severe postoperative pain at the surgical site.
      However, current methods of pain control are mostly insufficient. At present, several pain
      controlling methods are available, to reduce postoperative pain after laminoplasty or
      laminectomy. Methods for systemic administration include: oral analgesics, intermittent
      intravenous, intramuscular injections, patient- controlled intravenous analgesia, etc.
      However, the aforementioned methods may have a lot of side effects, and are usually used
      after the occurrence of pain and the analgesic effects are sometimes inadequate. Topical
      administration options use a lower dose of drugs and therefore have less systemic side
      effects. Pre-emptive injection of local anesthetics can significantly reduce postoperative
      pain during rest and movement, however, the analgesic effect is maintained for a relatively
      short period of time. It is necessary to use more cases to explore the other compatibility of
      drugs with longer duration of action and stronger analgesic effect. Betamethasone as the
      stereoisomer of dexamethasone is a long-acting corticosteroid, which has long lasting
      anti-inflammatory properties. Whether betamethasone combined with local anesthetic for
      laminoplasty or laminectomy has better short-term and long-term effects than the local
      anesthetic alone has not been reported yet. Therefore, a prospective, randomized, controlled,
      blinded-endpoint study is needed to compare the postoperative analgesic efficacy of
      preemptive wound infilteration of ropivacaine alone and betamethasone plus ropivacaine for
      laminectomy or laminoplasty.
    


Intervention name(s): The Treatment group; The Control group
Intervention type(s): Drug; Drug
Intervention description(s): The local infiltration solution in the treatment group will consist of betamethasone and ropivacaine. For local infiltration, a total of 30 ml solution will be prepared for each group, which will include 0.5ml of compound betamethasone injection(betamethasone propionate 5mg and betamethasone sodium phosphate 2mg per 1ml) added to 14.5ml of saline and 15ml of 1% ropivacaine. The surgeon will perform wound infiltration after induction of anesthesia and before surgery. A total of 10 ml of solution will be injected into each level. The study solution will be injected into the subcutaneous tissue, paravertebral muscles, along with the posterior area around the spinous process, lamina, transverse process and the facet joints, along both sides of the planned incision. The epidural space and intrathecal space will not be infiltrated.; The local infiltration solution in the control group will consist of ropivacaine. For local infiltration, a total of 30 ml solution will be prepared for each group, which will include 15ml of ropivacaine added to 15 ml of saline for the Control group. The surgeon will perform wound infiltration after induction of anesthesia and before surgery. A total of 10 ml of solution will be injected into each level. The study solution will be injected into the subcutaneous tissue, paravertebral muscles, along with the posterior area around the spinous process, lamina, transverse process and the facet joints, along both sides of the planned incision. The epidural space and intrathecal space will not be infiltrated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pain, Postoperative; Betamethasone;; Ropivacaine;; Wound Infiltration; Laminoplasty or Laminectomy