This study aims to compare the efficacy of intrathecal morphine and intrathecal dexmedetomidine in reducing pain following lumbar spine fixation surgeries.
Spine surgeries represent a challenge to the anesthetists, as they are accompanied by multiple perioperative problems, including significant intraoperative blood loss and severe postoperative pain. Morphine is a prototypical opioid analgesic that acts mainly on mu-opioid receptors in the central nervous system. It exerts its analgesic effects by binding to these receptors, inhibiting the release of a neurotransmitter known as substance P, thereby diminishing pain perception. Dexmedetomidine (DEX) is a highly selective and potent α-2 adrenoceptor agonist. Its intrathecal administration leads to anti-nociceptive effects, although it has some undesired side effects (e.g., hypotension, bradycardia, and sedation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Patients will receive intrathecal morphine (0,3 mg) in 2 ml normal saline at the end of the operation through a 25G spinal needle through the lumbar intervertebral space (L3-L4 or L4-L5).
Patients will receive intrathecal 2 ml normal saline at the end of the operation through a 25G spinal needle through the lumbar intervertebral space (L3-L4 or L4-L5).
Patients will receive intrathecal 2 ml normal saline at the end of the operation through a 25G spinal needle through the lumbar intervertebral space (L3-L4 or L4-L5).
Tanta University
Tanta, El-Gharbia, Egypt
RECRUITINGTime to the first rescue analgesia
Time to the first rescue analgesia will be recorded from the end of surgery till the first dose of pethidine adminstrated.
Time frame: 24 hours postoperatively
Heart rate
Heart rate will be recorded at rest (static) and on movement (dynamic), evaluated at 30 minutes, 1, 2, 4, 8, 12, and 24 h after surgery.
Time frame: 24 hours postoperatively
Mean arterial pressure
Mean arterial pressure will be recorded at rest (static) and on movement (dynamic), evaluated at 30 minutes, 1, 2, 4, 8, 12, and 24 h after surgery.
Time frame: 24 hours postoperatively
Degree of pain
Postoperative pain will be assessed using visual analog scale (VAS) scores where (0 = no pain, 10 = the worst possible pain), postoperative pain will be assessed at rest (static) and on movement (dynamic), evaluated at 30 minutes, 1, 2, 4, 8, 12, and 24 h after surgery
Time frame: 24 hours postoperatively
Postoperative sedation score
The Sedation Scale (modified Observer's Assessment of Alertness/Sedation (OAA/S) scale). (6 = Agitated, 5 = Responds readily to name spoken in normal tone, 4 = Lethargic response to name spoken in normal tone, 3 = Responds only after name is called loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Does not respond to mild prodding or shaking, 0 = Does not respond to deep stimulus)
Time frame: 24 hours postoperatively
Total pethidine consumption
After assessment of pain scores, when visual analog scale (VAS) score measures ≥3, patients will receive 25 mg pethidine, which can be repeated.
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Time frame: 24 hours postoperatively
Incidence of adverse effect
Incidence of adverse effect such as pruritus, nausea/vomiting, bradycardia, hypotension, and respiratory depression will be recorded.
Time frame: 24 hours postoperatively