Bone FractureNCT05751304
A Comparative Study Between Intrathecal Dexmedetomidine VS Ketamine With Intrathecal Bupivacaine in Orthopedic Lower Limb Surgeries.
A study testing Dexmedetomidine and Ketamine in people with Bone Fracture, run by Sohag University at 1 site in Egypt.
Trial summary
Orthopedic anaesthesia and acute postoperative pain management, two anesthesiology subspecialties,are getting more credit for reducing hospital stays, promoting functional recovery and improving patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Fracture
- What is being tested?
- Dexmedetomidine and Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -The study will include 100 adult patients (18 to 50 years old) with ASA physical status class I and class II undergoing orthopedic lower limb surgeries under itrathecal anathesia .
Who cannot join
- Patient refusal.
- Drug abuse.
- Patient with neurological, psychiatric or neuromuscular disease.
- Chronic pain on medicine.
- Known allergy to the study medications.
- Patients e contraindications to intrathecal anesthesia .
Trial locations and contacts
1 site in 1 country.
Ahmed E Abd Elrahman, Professor contact
About this study
Orthopedic anaesthesia and acute postoperative pain management, two anesthesiology subspecialties,are getting more credit for reducing hospital stays, promoting functional recovery and improving patient satisfaction.
- Conditions
- Bone Fracture
- Being tested
- Dexmedetomidine, Ketamine
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 5μg Dexametomidine.
KetamineDrug
(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 0.1 mg/kg ketamine.
| Study group | Role | What they receive |
|---|---|---|
| Group D | Active comparator | (50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 5μg dexametomidine. Receives: Drug: Dexmedetomidine |
| Group K | Active comparator | (50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 0.1 mg/kg ketamine. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery
comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bone FractureStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziad Ahmed Ali, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751304
- Sponsor's protocol ID
- Soh-Med-23-02-09
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
PubMed 22227789Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
PubMed 16698416Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.
PubMed 11460814Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg. 2007 Jul;105(1):205-21. doi: 10.1213/01.ane.0000268145.52345.55.
PubMed 17578977
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Intrathecal Dexmedetomidine VS Ketamine With Intrathecal Bupivacaine in Orthopedic Lower Limb Surgeries.
- ClinicalTrials.gov ID
- NCT05751304
- Acronym / sponsor ID
- Soh-Med-23-02-09
- Conditions
- Bone Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 2 Mar 2023 (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.
Orthopedic anaesthesia and acute postoperative pain management, two anesthesiology subspecialties,are getting more credit for reducing hospital stays, promoting functional recovery and improving patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Active comparator | Drug: Dexmedetomidine(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 5μg dexametomidine. |
| Group K | Active comparator | Drug: Ketamine(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 0.1 mg/kg ketamine. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -The study will include 100 adult patients (18 to 50 years old) with ASA physical status class I and class II undergoing orthopedic lower limb surgeries under itrathecal anathesia .
Key exclusion criteria (6 listed)
- Patient refusal.
- Drug abuse.
- Patient with neurological, psychiatric or neuromuscular disease.
- Chronic pain on medicine.
- Known allergy to the study medications.
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 |
|---|---|---|
| Dexmedetomidine(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 5μg Dexametomidine. | Drug | Group D |
| Ketamine(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 0.1 mg/kg ketamine. | Drug | Group K |
Primary outcome
comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery
Time frame: 1 year
comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Background: PubMed 22227789American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
- Background: PubMed 16698416Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
- Background: PubMed 11460814Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.
- Background: PubMed 17578977Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg. 2007 Jul;105(1):205-21. doi: 10.1213/01.ane.0000268145.52345.55.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed E Abd Elrahman, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Ketamine in people with Bone Fracture, 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 1 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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zeyad A Ali, Resident (01159596946, zeyadahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery (time frame: 1 year). 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 NCT05751304, which also lists 4 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 2 Mar 2023.