Management of Pain in Lumbar Arthrodesis

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• Pain, Postoperative 5,095

Pain, Postoperative

5,095 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 128 is above the median of 75 across 4,346 interventional studies indexed under Pain, Postoperative.

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta is the lead sponsor of 29 studies on the registry; 8 are open to participants now.

Study arms

• Experimental
  Ketamina bolus plus Dexamethasone bolus plus infusion ketamine

  Ketamine bolus (0.5 mg / kg) + dexamethasone 0.1 mg / kg bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the Post-Anesthesia Resuscitation Unit (URPA)

  Drug: Ketamine · Drug: Dexamethasone

• Experimental
  Ketamine bolus plus ketamine infusion

  Ketamine bolus (0.5 mg / kg) + physiological serum bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the URPA.

  Drug: Ketamine · Drug: Physiologic saline

• Active comparator
  Dexametasone arm

  Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA

  Drug: Dexamethasone · Drug: Physiologic saline

• Placebo comparator
  Saline bolus

  Saline bolus + saline bolus + saline infusion up to three hours after admission to the URPA

  Drug: Physiologic saline

Interventions

• DrugKetamine

  Ketamine, being a non-competitive antagonist of NMDA receptors, could represent a good option as an opioid treatment enhancer for acute postoperative pain and avoid chronic pain, by reducing the '' wind-up '' phenomenon of central sensitization

• DrugDexamethasone

  A meta-analysis published in September 2011 affirms that the administration of dexamethasone at a dose of 0.1 mg / kg is an effective complement to multimodal analgesia strategies to reduce postoperative pain and opioid consumption after surgery. Preoperative administration of the drug produces a more consistent analgesic effect than intraoperative administration

• DrugPhysiologic saline

  placebo

Primary outcomes

1. Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period. Consumption of morphics will be evaluated

   Consumption of morphics

   Time frame: 4 hours post operative

Secondary outcomes

1. Incidence of postoperative nausea and vomiting (PONV).

   Incidence of postoperative nausea and vomiting

   Time frame: 4 hours post operative

2. Efficay of study treatment regarding pain at 3 postoperative months

   Pain at 3 postoperative months assessed by EVA scale pain. This is a visual analogue scale regarding pain.It consists of a 10-centimeter horizontal line, at the ends of which are the extreme expressions of a symptom. In the left is the absence or less intensity and in the right the greater intensity. The patient is asked to mark on the line the point that indicates the intensity and measure it with a millimeter ruler. The intensity is expressed in centimeters or millimeters. The evaluation will be: 1.Mild pain if the patient scores pain less than 3. 2.Moderate pain if the evaluation is between 4 and 7. 3.Severe pain if the evaluation is equal to or greater than 8.

   Time frame: 3 months

3. Adverse side effects:Hallucinations / Delirium.Sedation. Diplopia, Hyperglycemia Respiratory depression (Sat <90%)

   Rate of patients that presented adverse events

   Time frame: 4 hours post operative