Intrathecal Morphine Versus Intrathecal Dexmedetomidine Compared to Placebo for Postoperative Pain Relief After Spine Fixation Surgeries

NCT07777627 — Not applicable, Recruiting, 90 participants, Tanta University

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Intrathecal Morphine Versus Intrathecal Dexmedetomidine Compared to Placebo for Postoperative Pain Relief After Spine Fixation Surgeries: A Randomized Double-Blinded Study

RegistryNCT07777627
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment90 (Estimated)
SponsorTanta University (Other)
ConditionsIntrathecal Morphine, Intrathecal Dexmedetomidine, Placebo, Postoperative Pain, Spine Fixation Surgeries
InterventionsIntrathecal Morphine, Intrathecal Dexmedetomidine, Normal Saline (Drug)
Datesstart 2026-07-01, primary completion 2028-07-01 (estimated), completion 2028-07-01 (estimated), first posted 2026-08-20, last updated 2026-08-20
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Intrathecal Morphine All trials for Intrathecal Dexmedetomidine All trials of Intrathecal Morphine All trials of Intrathecal Dexmedetomidine

-Summary

This study aims to compare the efficacy of intrathecal morphine and intrathecal dexmedetomidine in reducing pain following lumbar spine fixation surgeries.

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
Group I (Morphine group)ExperimentalDrug: Intrathecal MorphinePatients 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).
Group II (Dexmedetomidine group)ExperimentalDrug: Intrathecal DexmedetomidinePatients will receive intrathecal dexmedetomidine (8mcg) 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).
Group III (Placebo group)Placebo comparatorDrug: Normal SalinePatients 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).
  • Intrathecal Morphine (Drug): 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).
  • Intrathecal Dexmedetomidine (Drug): 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).
  • Normal Saline (Drug): 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).

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.

+Eligibility

Sex: All, ages: 21 Years to 60 Years

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.

+Locations (1)

FacilityCityCountryStatus
Tanta UniversityTanta, El-GharbiaEgyptRecruiting