Fracture PelvisEarly Phase 1NCT07485127
Comparison Between Dexamethasone and Dexmedetomidine in Spinal Anesthesia for Cases With Fracture Pelvis Fixation
A Early Phase 1 study testing 60 patients will be involved, half patients will receive 13mg bupivacaine + 4 mg dexamethasone. The other half will receive 13mg bupivacaine + 4 mg dexmedetomidine. All will be monitored closely. in people with Fracture Pelvis, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to compare dexamethasone and dexmedetomidine as adjuvant to bupivacaine in fracture pelvis fixation as regard duration of sensory block and postoperative pain management. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Fracture Pelvis
- What is being tested?
- 60 patients will be involved, half patients will receive 13mg bupivacaine + 4 mg dexamethasone. The other half will receive 13mg bupivacaine + 4 mg dexmedetomidine. All will be monitored closely.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Feb 2026to 31 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 20 to 80 years.
- Both sexes.
- Patients will be classified as American Society of Anesthesiologists (ASA) class I - II.
- Patient scheduled for surgical fixation of pelvic fracture.
Who cannot join
- Patients with drug addiction, and sepsis.
- Infection at the injection site.
- Sensitivity to local anesthetics.
- Coagulopathy.
- Kidney failure, liver failure.
- History of previous paresis in the operation area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Dexamethasone and Dexmedetomidine as Adjuvant to Bupivacaine in Spinal Anesthesia for Cases With Fracture Pelvis Fixation Comparative Randomized Study
The aim of this study is to compare dexamethasone and dexmedetomidine as adjuvant to bupivacaine in fracture pelvis fixation as regard duration of sensory block and postoperative pain management.
Read the detailed description
Place of the study:
Sohag University Hospitals after approval from the institutional ethical committee.
Study Design:
This prospective comparative study will be conducted on patients with fracture pelvis at the Department of Anesthesia, Intensive Care, and Pain Management,in Sohag University Hospitals after approval of the Research Ethical Committee.
Study period:
From February 2026 to August 2026.
- Conditions
- Fracture Pelvis
- Being tested
- 60 patients will be involved, half patients will receive 13mg bupivacaine + 4 mg dexamethasone. The other half will receive 13mg bupivacaine + 4 mg dexmedetomidine. All will be monitored closely.
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60 patients will be involved, half patients will receive 13mg bupivacaine + 4 mg dexamethasone. The other half will receive 13mg bupivacaine + 4 mg dexmedetomidine. All will be monitored closely.Drug
Intraoperative and postoperative pain management
| Study group | Role | What they receive |
|---|---|---|
| • Dexamethasone Group (n=30) | Active comparator | Patients will receive bupivacaine plus dexamethasone. Receives: Drug: 60 patients will be involved, half patients will receive 13mg bupivacaine + 4 mg dexamethasone. The other half will receive 13mg bupivacaine + 4 mg dexmedetomidine. All will be monitored closely. |
| • Dexmedetomidine Group (n=30) | Active comparator | Patients will receive bupivacaine plus dexmedetomidine. Receives: Drug: 60 patients will be involved, half patients will receive 13mg bupivacaine + 4 mg dexamethasone. The other half will receive 13mg bupivacaine + 4 mg dexmedetomidine. All will be monitored closely. |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Duration of block.
Spinal anesthesia involves injecting a local anesthetic into the CSF. It is preferred when the surgical site is suitable for spinal blockade, especially in patients with severe respiratory disease or difficult tracheal intubation. Bupivacaine is a long-acting local anesthetic used for spinal anesthesia. By blocking sodium channels, it produces rapid, profound sensory and motor blockade with onset within minutes and a duration of 1.5-4 hours. To enhance local anesthetic effects, various adjuvants have been studied to improve onset, duration, and block quality. Dexamethasone as an adjuvant to bupivacaine prolongs block duration, improves onset, intensity, sedation, and reduces postoperative pain. Dexmedetomidine, an alpha-2 agonist, provides sedation, anxiolysis, and analgesia; it shortens onset, prolongs block duration, delays analgesic need, and has minimal side effects.
Measured: onset of a few minutes and duration of 1.5-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start8 Feb 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fracture PelvisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soha Mohamed, Sohag University
- Investigators
- Waleed A Ahmed, Lecturer, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485127
- Sponsor's protocol ID
- Dexamethasone, Dexmedetomidine
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tang, P., Chen, H., Zhao, Z. and Wu, Y.(2023). Pelvic fractures. Orthopaedic Trauma Surgery: Volume 3: Axial Skeleton Fractures and Nonunion: Springer; 2023. p. 73-130.
Meyhoff CS, Thomsen CH, Rasmussen LS, Nielsen PR. High incidence of chronic pain following surgery for pelvic fracture. Clin J Pain. 2006 Feb;22(2):167-72. doi: 10.1097/01.ajp.0000174266.12831.a2.
PubMed 16428951
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Dexamethasone and Dexmedetomidine as Adjuvant to Bupivacaine in Spinal Anesthesia for Cases With Fracture Pelvis Fixation Comparative Randomized Study
- ClinicalTrials.gov ID
- NCT07485127
- Acronym / sponsor ID
- Dexamethasone, Dexmedetomidine
- Conditions
- Fracture Pelvis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 8 Feb 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare dexamethasone and dexmedetomidine as adjuvant to bupivacaine in fracture pelvis fixation as regard duration of sensory block and postoperative pain management.
Detailed description
Place of the study:
Sohag University Hospitals after approval from the institutional ethical committee.
Study Design:
This prospective comparative study will be conducted on patients with fracture pelvis at the Department of Anesthesia, Intensive Care, and Pain Management,in Sohag University Hospitals after approval of the Research Ethical Committee.
Study period:
From February 2026 to August 2026.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • Dexamethasone Group (n=30) | Active comparator | Drug: 60 patients will be involved, half patients will receive 13mg bupivacaine + 4 mg dexamethasone. The other half will receive 13mg bupivacaine + 4 mg dexmedetomidine. All will be monitored closely.Patients will receive bupivacaine plus dexamethasone. |
| • Dexmedetomidine Group (n=30) | Active comparator | Drug: 60 patients will be involved, half patients will receive 13mg bupivacaine + 4 mg dexamethasone. The other half will receive 13mg bupivacaine + 4 mg dexmedetomidine. All will be monitored closely.Patients will receive bupivacaine plus dexmedetomidine. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 20 to 80 years.
- Both sexes.
- Patients will be classified as American Society of Anesthesiologists (ASA) class I - II.
- Patient scheduled for surgical fixation of pelvic fracture.
Key exclusion criteria (6 listed)
- Patients with drug addiction, and sepsis.
- Infection at the injection site.
- Sensitivity to local anesthetics.
- Coagulopathy.
- Kidney failure, liver failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 60 patients will be involved, half patients will receive 13mg bupivacaine + 4 mg dexamethasone. The other half will receive 13mg bupivacaine + 4 mg dexmedetomidine. All will be monitored closely.Intraoperative and postoperative pain management | Drug | • Dexamethasone Group (n=30), • Dexmedetomidine Group (n=30) |
Primary outcome
• Duration of block.
Time frame: onset of a few minutes and duration of 1.5-4 hours
Spinal anesthesia involves injecting a local anesthetic into the CSF. It is preferred when the surgical site is suitable for spinal blockade, especially in patients with severe respiratory disease or difficult tracheal intubation. Bupivacaine is a long-acting local anesthetic used for spinal anesthesia. By blocking sodium channels, it produces rapid, profound sensory and motor blockade with onset within minutes and a duration of 1.5-4 hours. To enhance local anesthetic effects, various adjuvants have been studied to improve onset, duration, and block quality. Dexamethasone as an adjuvant to bupivacaine prolongs block duration, improves onset, intensity, sedation, and reduces postoperative pain. Dexmedetomidine, an alpha-2 agonist, provides sedation, anxiolysis, and analgesia; it shortens onset, prolongs block duration, delays analgesic need, and has minimal side effects.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- BackgroundTang, P., Chen, H., Zhao, Z. and Wu, Y.(2023). Pelvic fractures. Orthopaedic Trauma Surgery: Volume 3: Axial Skeleton Fractures and Nonunion: Springer; 2023. p. 73-130.
- Background: PubMed 16428951Meyhoff CS, Thomsen CH, Rasmussen LS, Nielsen PR. High incidence of chronic pain following surgery for pelvic fracture. Clin J Pain. 2006 Feb;22(2):167-72. doi: 10.1097/01.ajp.0000174266.12831.a2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed A Ahmed, Lecturer study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 60 patients will be involved, half patients will receive 13mg bupivacaine + 4 mg dexamethasone. The other half will receive 13mg bupivacaine + 4 mg dexmedetomidine. All will be monitored closely. in people with Fracture Pelvis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Duration of block. (time frame: onset of a few minutes and duration of 1.5-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07485127, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.