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NCT Number: NCT07777627

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

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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Key information

Conditions

Intrathecal Morphine Intrathecal Dexmedetomidine Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Placebo Postoperative Complications Postoperative Pain Signs and Symptoms Spine Fixation Surgeries

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Abdelhamed I Badreldin, MSc

CONTACT

[email protected]

00201090690631

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Time to the first rescue analgesia

    Time frame: 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

  1. Heart rate

    Time frame: 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.

  2. Mean arterial pressure

    Time frame: 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.

  3. Degree of pain

    Time frame: 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

  4. Postoperative sedation score

    Time frame: 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)

  5. Total pethidine consumption

    Time frame: 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.

  6. Incidence of adverse effect

    Time frame: 24 hours postoperatively

    Incidence of adverse effect such as pruritus, nausea/vomiting, bradycardia, hypotension, and respiratory depression will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelhamed I Badreldin, MSc

CONTACT

[email protected]

00201090690631

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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