Local Anesthetic Infiltration to Prevent Postoperative Pain After Lumbar Surgery
Condition: Hyperalgesia
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 3

Summary: 
      Posterior lumbar arthrodesis causes severe postoperative pain, hampering patients's
      postoperative reconvalescence especially functional rehabilitation. Efficient and safe
      methods for postoperative analgesia are, therefore, mandatory. The application of opioids are
      the most frequently used therapies for postoperative pain relief but it very often results
      side effects. Local anesthetic wound infiltration is widely recognized as a useful adjunct in
      a multimodal approach to postoperative pain management. In the setting of spine surgery, a
      single bolus administration of a local anesthetic is a useful method (with a reduction in
      parenteral morphine consumption during the 48 first hours) but has a limited effect because
      of its short duration of action. Prolonged administration through a multi-holed catheter
      positioned by the surgeon at the end of the procedure could increase the duration of action
      and may thereby improve the efficacy of local wound infiltration. Easy and effective, this
      new modality of administration has expanded the indications for parietal infiltrations toward
      major painful procedures.

      We designed this study to determine whether local anesthetic (compared with saline solution)
      continuous wound infiltration during the first two days after posterior lumbar arthrodesis on
      degenerative spine, could improve postoperative analgesia at short-term but particularly at
      mid-term (two months) and long-term (six months), in order to decrease postoperative lumbar
      pains (resulting in best life quality, opioid consumption limited and rehabilitation
      hastened) and postoperative hyperalgesia areas. The postoperative analgesic and
      antihyperalgesic efficacies; the postoperative rehabilitation at mid-term and long term, and
      the safety of opioid administration and multi-holed parietal catheter will be compared in the
      two groups (control and study).
    

Detailed description: 
      Blockade of parietal nociceptive afferents by the use of continuous wound infiltration with
      local anesthetics may be beneficial in a multimodal approach to postoperative pain management
      after major surgery. The role of continuous wound parietal paravertebral infiltration of
      ropivacaine for pain relief and postoperative rehabilitation after posterior lumbar
      arthrodesis will be evaluated in a randomized, monocentric, double-blinded, superiority
      controlled trial.

      The general purpose of this clinical research is the assessment of efficacy and safety of
      continuous wound infiltration with ropivacaine through a parietal paravertebral catheter for
      postoperative analgesia, and his repercussions at mid (two months) and long (six months)-term
      after posterior lumbar arthrodesis on degenerative spine.

      The principal purpose concerns the assessment of postoperative analgesic efficacy at mid-term
      (two months after surgery) of continuous wound infiltration with ropivacaine (compared with
      saline solution), through a parietal paravertebral multi-holed catheter, after posterior
      lumbar arthrodesis.

      After obtaining written informed consents, the patients scheduled to undergo posterior lumbar
      arthrodesis on degenerative spine,.will be randomly allocated to receive a continuous wound
      infusion of either 0.2% ropivacaine (ropivacaine group A) or 0.9% saline (control group B)
      when they will arrive in the operating room. The surgeon will perform a standardized
      posterior median incision at the level of lumbar intervertebral instability. Before putting
      retractors, he will infiltrate all surgical strata and the paraspinal muscles all long the
      wound bilaterally with a solution of ropivacaine 0.5% 20 mL (group A) or with a solution of
      0,9% NaCl 20 ml (group B). At the end of surgery, a multi-holed wound catheter will be placed
      by the surgeon, under direct visualization, in the paravertebral space ; between the muscle
      fascia and subcutaneous tissues all along the wound, and fixed at the skin by a stitch. The
      patients will be thereafter randomly assigned to receive through the catheter either 0.2%
      ropivacaine (study group) (5-ml bolus followed by an infusion of 8 ml/h during 48 h) or the
      same protocol with 0.9% NaCl (control group), thanks to a prefilled elastomeric pump (400ml),
      set to deliver a 8-ml/h connected with the catheter. In addition, all patients will receive
      patient-controlled intravenous morphine analgesia. After the induction, the anaesthesist will
      install a peripheral venous catheter for each patient in order to make blood samples easier
      (eight peroperative and two postoperative blood samples for each patient, with the aim of
      ropivacaine pharmacokinetic study).
    

Intervention name(s): Ropivacaine / Placebo
Intervention type(s): Drug
Intervention description(s): Wound infiltration with local anesthesics/placebo through a parietal paravertebral catheter
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Posterior lumbar arthrodesis; Degenerative spine; Postoperative analgesia; Local anesthesic; Continuous wound infusion catheter; Pain; lumbar vertebrae; Spinal fusion