Pre-emptive Dexamethasone in Hip Arthroplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      -  Certain studies suggested that preoperative administration of systemic glucocorticoids
           in patients undergoing hip or knee arthroplasty surgery may improve the postoperative
           analgesia owing to their anti-inflammatory effect.

        -  This study will be carried out on 70 adult patients aged 21 to 75 years admitted to
           orthopedic operating rooms in Tanta university hospitals for hip surgery under spinal
           anesthesia. Informed written consent will be obtained from each participant.

        -  Patients will be randomly distributed into two equal groups using the computer-generated
           software.

             -  Control Group: (35 patients) Those patients will receive 10 ml of normal saline
                before surgery.

             -  Dexamethasone Group: (35 patients) Those patients will receive 16 mg dexamethasone
                in 10 ml of normal saline before surgery.

        -  Primary outcome will be postoperative morphine consumption and the secondary outcome
           will be the postoperative pain score
    

Detailed description: 
      - This randomized controlled prospective study will be carried out on 70 adult patients aged
      21 to 75 years admitted to orthopedic operating rooms in Tanta University Hospital for hip
      surgery under spinal anesthesia. I

      Patients will be randomly distributed into two equal groups using the computer-generated
      software. An anesthesia resident who will be blinded to the study groups and not
      participating in it will help in the preparation of uniform 10-ml syringes that contain
      normal saline in the control group and 16 mg dexamethasone in the other group.

        -  Control Group: (35 patients) Those patients will receive 10 ml of normal saline before
           surgery.

        -  Dexamethasone Group: (35 patients) Those patients will receive 16 mg dexamethasone in 10
           ml of normal saline before surgery.

      All the patients will undergo standardized preoperative assessment consisted of history
      taking, general and regional examination, and requesting preoperative investigations
      including (complete blood count (CBC), coagulation profile, and renal function tests). Upon
      patient admission to the operating theater, they will be attached to a monitor consisting of
      pulse oximetry, 5 lead ECG, non-invasive blood pressure, end-tidal carbon dioxide (Co2), and
      temperature. Then, intravenous access will be established through the insertion of an
      18-gauge peripheral venous cannula, then, lactated ringer solution 7ml/kg over 30 minutes
      will be started. All the equipment required for spinal anesthesia, general anesthesia, and
      nerve block will be prepared by an expert anesthesiologist who will not be participating in
      this research. Also, the resuscitation equipment will be prepared before starting anesthesia.

      Under complete aseptic precautions and local anesthetic skin infiltration with 3 ml lidocaine
      1% at L3-L4 or L4-L5 intervertebral space, midline approach spinal anesthesia will be
      performed using a 25 G spinal needle. Once intrathecal placement will be confirmed, a mixture
      of 2 ml of hyperbaric bupivacaine (10 mg) and 0.5 ml of fentanyl (25 ugs) will be injected.
      The patient will be monitored for the hemodynamic parameters including the heart rate and the
      mean arterial pressure every 3 minutes. Moreover, the sensory and motor blockade will be
      assessed.

      Oxygen will be applied to the patient with the aid of an oxygen mask at a flow rate of 4
      L/min. The pinprick test from caudal to cephalic direction using a 26-gauge needle will be
      used to evaluate the sensory block until the sensory level reached the level of T11 or
      higher. The motor block will be assessed every 5 minutes by the Bromage score (grade 3: no
      movement, grade 2: unable to flex knees and can flex ankle, grade 1: unable to raise an
      extended leg but able to move the knees and ankles, grade 0: no paralysis) until reaching a
      score of 2 or 3. If no adequate sensory or motor blockade will be obtained within 20 minutes,
      the patient will receive general anesthesia and be excluded from the study. A decrease in the
      heart rate below 50 b/min will be managed by atropine 0.3 mg i.v, while a decrease in the
      mean arterial pressure below 65 mmHg will be managed by 10 mg ephedrine i.v and intravenous
      fluids.

      Primary outcome will be postoperative morphine consumption and the secondary outcome will be
      the postoperative pain score
    

Intervention name(s): Normal saline; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): The patients will receive 10 ml of normal saline as a placebo dexamethasone before surgery.; Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.
Other intervention name(s): Placebo; Active group
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Dexamethasone; Hip arthroplasty; Postoperative pain