Intrathecal MorphineNCT07777627
Intrathecal Morphine Versus Intrathecal Dexmedetomidine Compared to Placebo for Postoperative Pain Relief After Spine Fixation Surgeries
A study testing Intrathecal Morphine, Intrathecal Dexmedetomidine and Normal Saline in people with Intrathecal Morphine and Intrathecal Dexmedetomidine, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy of intrathecal morphine and intrathecal dexmedetomidine in reducing pain following lumbar spine fixation surgeries. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Intrathecal Morphine, Intrathecal Dexmedetomidine, Placebo
- What is being tested?
- Intrathecal Morphine, Intrathecal Dexmedetomidine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Abdelhamed I Badreldin, MSc, 00201090690631, bedobadr30@gmail.com
About this study
Official title: Intrathecal Morphine Versus Intrathecal Dexmedetomidine Compared to Placebo for Postoperative Pain Relief After Spine Fixation Surgeries: A Randomized Double-Blinded Study
This study aims to compare the efficacy of intrathecal morphine and intrathecal dexmedetomidine in reducing pain following lumbar spine fixation surgeries.
Read the 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).
- Conditions
- Intrathecal Morphine, Intrathecal Dexmedetomidine, Placebo, Postoperative Pain, Spine Fixation Surgeries
- Being tested
- Intrathecal Morphine, Intrathecal Dexmedetomidine, Normal Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
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 DexmedetomidineDrug
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 SalineDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Group I (Morphine group) | Experimental | 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). Receives: Drug: Intrathecal Morphine |
| Group II (Dexmedetomidine group) | Experimental | Patients 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). Receives: Drug: Intrathecal Dexmedetomidine |
| Group III (Placebo group) | Placebo comparator | 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). Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 24 hours postoperatively
Incidence of adverse effect
Incidence of adverse effect such as pruritus, nausea/vomiting, bradycardia, hypotension, and respiratory depression will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Jul 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrathecal MorphineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelhamed Ibrahim Abdelhamed Badreldin, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777627
- Sponsor's protocol ID
- 36265MD41084/6/26
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.