Evaluation of the Analgesic Effect of Dexmedetomidine Versus Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries
Condition: Dexmedetomidine VS Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries
Study type: Interventional

Summary: 
      To determine if the epidural route provide an acceptable analgesia in spine surgeries and
      avoided the need for excessive IV analgesics. Also to determine whatever dexmedetomidine or
      fentanyl is more better neuroaxial adjuvant regarding providing early onset and prolonged
      analgesia and stable cardiorespiratory parameters
    

Detailed description: 
      Relieving post-operative pain of spine surgeries has become an indispensable component in
      anesthesiology. Various methods have been tried for the management of post-operative pain in
      spine surgeries out of which regional techniques are becoming most promising. The quality of
      regional anesthesia has been reported to improve with the addition of opioids (such as
      morphine, fentanyl, and sufentanil) and other drugs (such as dexmedetomidine, clonidine,
      magnesium sulfate, neostigmine, ketamine, and midazolam), but no drug to inhibit nociception
      is without associated adverse effects . α2 adrenergic agonists have both analgesic and
      sedative properties when used as an adjuvant in regional anesthesia. Dexmedetomidine is an
      S-enantiomer of medetomidine with a higher specificity for α2-adrenoreceptor (α2 : α1, 1620 :
      1) compared to clonidine (α2 : α1, 220 : 1). It was first introduced into practical use as
      intravenous sedative after the approval of U.S. Food and Drug Administration in 1999. Since
      then it has been investigated as the anxiolytic, sympatholytic, and analgesic properties
      related to α2-adrenoceptor binding, and it is now being used as a co-analgesic drug. As
      adjuvant, neuroaxial administration is the appropriate route to dexmedetomidine, because the
      analgesic effect of α2-agonists mostly occurs at spinal level, and dexmedetomidin's high
      lipophilicity facilitates rapid absorption into the cerebrospinal fluid and binding to the
      spinal cord α2-adrenoreceptor. regional-administeration of dexmedetomidine has been shown to
      exert potent antinociceptive effects in animals. To date, a few studies have reported on the
      effects of epidural dexmedetomidine combined with local anesthetics in humans. .
      Administration of an α2-agonist via an intrathecal or epidural route provides an analgesic
      effect in postoperative pain without severe sedation. This effect is due to the sparing of
      supraspinal CNS sites from excessive drug exposure, resulting in robust analgesia without
      heavy sedation . The adverse effects of dexmedetomidine include hypotension, hypertension,
      nausea, bradycardia, atrial fibrillation, and hypoxia. Fentanyl is one of the short-acting
      narcotic analgesics with potent morphine-like action . Neuroaxial administration of
      lipophilic opioids such as Fentanyl and sufentanyl tends to provide a rapid onset of
      analgesia. Their rapid clearance from cerebrospinal fluid may limit cephalic spread and the
      development of certain side effects such as delayed respiratory depression
    

Intervention name(s): Dexmedetomidine; Bupivacaine; Fentanyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All cases of spine surgery will be done under G.A with the patient in prone position. After surgery an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted .
The pain score, by using VAS
Onset of analgesia (fall of VAS<4 ).
Peak level of analgesia ( VAS score 0).
Duration of analgesia (once the patient asks fwith VAS>4).
Monitoring of NIBP, pulse rate, respiratory rate every 30 min.
Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale>1" Also deep sedation "Ramsay sedation scale>3" , And shivering and hypotension.; All cases of spine surgery will be done under G.A with the patient in prone position. After surgury an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted .
The pain score, by using VAS
Onset of analgesia (fall of VAS<4 ).
Peak level of analgesia ( VAS score 0).
Duration of analgesia (once the patient asks fwith VAS>4).
Monitoring of NIBP, pulse rate, respiratory rate every 30 min.
Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale>1" Also deep sedation "Ramsay sedation scale>3" , And shivering and hypotension.; All cases of spine surgery will be done under G.A with the patient in prone position. After surgury an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted .
The pain score, by using VAS
Onset of analgesia (fall of VAS<4 ).
Peak level of analgesia ( VAS score 0).
Duration of analgesia (once the patient asks fwith VAS>4).
Monitoring of NIBP, pulse rate, respiratory rate every 30 min.
Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale>1" Also deep sedation "Ramsay sedation scale>3" , And shivering and hypotension.
Other intervention name(s): Dexmedetomidine bupivacaine versus fentanyl bupivacaine
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This double-blind, prospective, randomised clinically controlled study is designed to study the efficacy of epidural analgesia of dexmedetomidine and compare the analgesic effect of its epidural injection with bupivacaine versus fentanyl with bupivacaine in the post operative period of elective spine surgeries.
To determine if the epidural route provide an acceptable analgesia in spine surgeries and avoided the need for excessive IV analgesics. Also to determine whatever dexmedetomidine or fentanyl is more better neuroaxial adjuvant regarding providing early onset and prolonged analgesia and stable cardiorespiratory parameters.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care