Intrathecal Morphine, Intrathecal Dexmedetomidine, Placebo, Postoperative Pain, Spine Fixation Surgeries
Conditions
Brief summary
This study aims to compare the efficacy of intrathecal morphine and intrathecal dexmedetomidine in reducing pain following lumbar spine fixation surgeries.
Detailed description
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).
Interventions
DRUGIntrathecal Morphine
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).
DRUGNormal Saline
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).
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 21 and 60 years. * Both sexes. * American Society of Anesthesiologists (ASA) Physical Status I or II. * Scheduled for elective lumbar spine fixation surgery under general anesthesia.
Exclusion criteria
* Patients' refusal. * Decompensated hepatic or renal or cardiac disease. * Coagulation disorder. * Pregnancy and lactation. * Body mass index above 30 kg/m2. * Severe pulmonary disorders. * Patients on opioid, alcohol or allergy to any of the study drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to the first rescue analgesia | 24 hours postoperatively | Time to the first rescue analgesia will be recorded from the end of surgery till the first dose of pethidine adminstrated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 24 hours postoperatively | 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. |
| Mean arterial pressure | 24 hours postoperatively | 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. |
| Degree of pain | 24 hours postoperatively | 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 |
| Postoperative sedation score | 24 hours postoperatively | 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) |
| Total pethidine consumption | 24 hours postoperatively | After assessment of pain scores, when visual analog scale (VAS) score measures ≥3, patients will receive 25 mg pethidine, which can be repeated. |
| Incidence of adverse effect | 24 hours postoperatively | Incidence of adverse effect such as pruritus, nausea/vomiting, bradycardia, hypotension, and respiratory depression will be recorded. |
Countries
Egypt
Contacts
CONTACTAbdelhamed I Badreldin, MSc
Outcome results
None listed