Caudal Epidural With Non Opioid Adjuvants in Lumbosacral Spine Surgery
Condition: Caudal Analgesia for Lumosacral Spine Surgeries
Study type: Interventional

Summary: 
      Lumbosacral spine surgeries are accompanied with severe postoperative pain which has a
      negative effect on patients' recovery. Preemptive analgesia before lumbosacral spine
      surgeries should be implemented to prevent CNS plasticity and to provide effective pain
      relief.

      The most common way to provide pain management after spine surgery is the intravenous
      analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain
      relief.

      The most common way to provide pain management after spine surgery is the intravenous
      analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain
      relief. acting drugs last from 4-8 hours,But this can be prolonged by adding non opioid
      adjuvants like steroid( dexamethazone,betamethasone), alpha2 agonists (clonidine,
      dexmedetomidine), or their combination. This study will compare adding different non opioid
      adjuvants to bupivacaine in caudal epidural for preventive analgesia in lumbosacral spine
      surgery which can be a part of multimodal analgesia protocol.

      .
    

Detailed description: 
      60 patient will be enrolled in the study. They will be allocated randomly into 3 groups.
      after induction of general anesthesia and changing the patient into prone position injection
      of the study cocktail through caudal epidural route.(20 ml before skin incision and 10 ml of
      the same mixture at the end of surgery) in all patients.

      In the first group patients will receive 0.125% bupivacaine with 8 mg dexamethasone In the
      second group we will add 50µg dexmedetomidine to the previous mixture given to the first
      group.

      In the third group we will add 1500 IU hyalurodinase to the mixture given to the first group

      During the operation adjustment of sevoflurane concentration and fentanyl incremental doses
      (0.5 μg/kg) will be according to hemodynamic measurements.

      Clinical signs of inadequate analgesia is defined as an increase in blood pressure and heart
      rate more than 20% from baseline. Efficacy of the caudal epidural block will be tested at
      beginning of skin incision (15-20 minutes after block). If signs of inadequate analgesia are
      observed, fentanyl 0.5 µg/kg will be given and those patients will be excluded from the
      study.

      In case of decrease in Blood Pressure greater than 20% from baseline, the patient will be
      infused by 500 ml ringer lactate and if blood pressure is not responding, administration of
      increments of 3 mg ephedrine will be given. Also If heart rate decreased to 45 beats/min,
      atropine sulfate 0.01 mg/kg will be given. Muscle paralysis will be antagonized by sugmmadex
      2mg/kg at the end of surgery after switching the patient to the supine position.
    

Intervention name(s): Bupivacaine; Dexamethasone; Dexmedetomidine; Hyalouridinase
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): local anesthetics, steriod, alpha 2 blockers; dexamethazone; dexmedetomidine; hyalouridinase
Intervention MeSH terms: Dexamethasone; Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment