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

ConditionsIntrathecal MorphineIntrathecal DexmedetomidinePlaceboPostoperative PainSpine Fixation Surgeries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorTanta University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients' refusal.

Decompensated hepatic or renal or cardiac disease.

Coagulation disorder.

Pregnancy and lactation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group I (Morphine group)Experimental treatment 1 intervention
Group B: Group II (Dexmedetomidine group)Experimental treatment 1 intervention
Group C: Group III (Placebo group)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time 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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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