Fracture Hip SurgeryPhase 3NCT06865469
Comparing Efficacy of Intravenous Dexmedetomidine and Lidocaine on Postoperative Analgesia in Patients Undergoing Fracture Hip Surgery
A Phase 3 study testing Dexmedetomidine and Lidocaine Hydrochloride 2% in people with Fracture Hip Surgery, run by Assiut University.
Trial summary
Perioperative pain management has been a major challenge for anesthesiologists, and there have been persistent efforts to bring out the best possible analgesic technique with the least side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture Hip Surgery
- What is being tested?
- Dexmedetomidine and Lidocaine Hydrochloride 2%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Sep 2026
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years old.
- patients with both sex
- patients who are American society of Anesthesiologists class I or II
Who cannot join
- refusal.
- body mass index (BMI) ≥40 kg/m2.
- History of hypersensitivity to the drugs being evaluated
- Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.
- chronic use of opioids and opioid addiction
About this study
Perioperative pain management has been a major challenge for anesthesiologists, and there have been persistent efforts to bring out the best possible analgesic technique with the least side effects.
Hip fractures are devastating injuries, constituting a global public health burden and remain one of the largest healthcare challenges of the 21st century. The incidence increases with advancing age and the number of hip fractures is expected to increase to 6.26 million per year in 2050.
Read more
Hip fractures impact on patient's psychological, functional, and social wellbeing, and account for substantial healthcare system costs.
Drugs of potential interest such as intravenous (i.v.) lidocaine and dexmedetomidine have been administered both intra and/or postoperatively to decrease perioperative pain and improve other outcomes. Lidoocaine has analgesic, anti inflammatory, and anti hyperalgesia properties.
Several studies have demonstrated that perioperative lidocaine infusion reduces postoperative pain intensity and opioid consumption .
Ease of availability, cost effectiveness, simplicity of administration, safety, and analgesic action make lignocaine an attractive option.
Dexmedetomidine is a highly selective and specific α2 adrenoceptor agonist with useful analgesic, sedative, anxiolytic, and sympatholytic properties.
I.V. dexmedetomidine has gained immense popularity owing to its efficacy as an analgesic adjuvant, translating into reduced opioid consumption.
Intraoperative dexmedetomidine and lignocaine also confirm the enhanced recovery after surgery protocol advocating the reduction of opioid use.
While numerous studies have analyzed i.v. lidoocaine and dexmedetomidine versus placebo regarding postoperative analgesia and outcomes, researches and evidence in the context of minimally invasive surgeries regarding adverse effect profile, postoperative analgesic requirement, perioperative analgesia, anesthesia recovery, and opioid requirements are always welcome(rephrase). Our study was conducted to analyze the effects of intraoperative i.v. lidocaine and dexmedetomidine on pain relief, intra- and postoperative opioid consumption, and effects of these infusions on intraoperative hemodynamic parameters and to evaluate the side effect profiles the aim of the study to analyze the effects of intraoperative intravenous lignocaine/dexmedetomidine on postoperative pain relief and analgesit consumption
- Conditions
- Fracture Hip Surgery
- Being tested
- Dexmedetomidine, Lidocaine Hydrochloride 2%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
dexmedetomidine will be administered by i.v. infusion at 0.4 μg/kg/h
Lidocaine Hydrochloride 2%Drug
lidocaine hydrochloride 2% (400 mg/20 mL) 1.5 mg/kg/h by i.v. infusion.
| Study group | Role | What they receive |
|---|---|---|
| Group D | Active comparator | patients will recive dexmedetomidine i.v. infusion at 0.4 μg/kg/h Receives: Drug: Dexmedetomidine |
| Group L | Active comparator | patients will received 1.5 mg/kg/h lidocaine hydrochloride 2% (400 mg/20 mL) by i.v. infusion. Receives: Drug: Lidocaine Hydrochloride 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score NRS score
The severity of pain will be assessed postoperatively using a 10 cm NRS (0 = no pain and 10 = worst imaginable pain) at rest and coughing at 0, 2nd, 4th, 6th, 12th, 18th, and 24th hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture Hip SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Mamdouh Kotp Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865469
- Sponsor's protocol ID
- Dex vs lidocaine fracture hip
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy of Intravenous Dexmedetomidine and Lidocaine on Postoperative Analgesia in Patients Undergoing Fracture Hip Surgery
- ClinicalTrials.gov ID
- NCT06865469
- Acronym / sponsor ID
- Dex vs lidocaine fracture hip
- Conditions
- Fracture Hip Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 7 Mar 2025 (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.
Perioperative pain management has been a major challenge for anesthesiologists, and there have been persistent efforts to bring out the best possible analgesic technique with the least side effects.
Hip fractures are devastating injuries, constituting a global public health burden and remain one of the largest healthcare challenges of the 21st century. The incidence increases with advancing age and the number of hip fractures is expected to increase to 6.26 million per year in 2050.
Hip fractures impact on patient's psychological, functional, and social wellbeing, and account for substantial healthcare system costs.
Drugs of potential interest such as intravenous (i.v.) lidocaine and dexmedetomidine have been administered both intra and/or postoperatively to decrease perioperative pain and improve other outcomes. Lidoocaine has analgesic, anti inflammatory, and anti hyperalgesia properties.
Several studies have demonstrated that perioperative lidocaine infusion reduces postoperative pain intensity and opioid consumption .
Ease of availability, cost effectiveness, simplicity of administration, safety, and analgesic action make lignocaine an attractive option.
Dexmedetomidine is a highly selective and specific α2 adrenoceptor agonist with useful analgesic, sedative, anxiolytic, and sympatholytic properties.
I.V. dexmedetomidine has gained immense popularity owing to its efficacy as an analgesic adjuvant, translating into reduced opioid consumption.
Intraoperative dexmedetomidine and lignocaine also confirm the enhanced recovery after surgery protocol advocating the reduction of opioid use.
While numerous studies have analyzed i.v. lidoocaine and dexmedetomidine versus placebo regarding postoperative analgesia and outcomes, researches and evidence in the context of minimally invasive surgeries regarding adverse effect profile, postoperative analgesic requirement, perioperative analgesia, anesthesia recovery, and opioid requirements are always welcome(rephrase). Our study was conducted to analyze the effects of intraoperative i.v. lidocaine and dexmedetomidine on pain relief, intra- and postoperative opioid consumption, and effects of these infusions on intraoperative hemodynamic parameters and to evaluate the side effect profiles the aim of the study to analyze the effects of intraoperative intravenous lignocaine/dexmedetomidine on postoperative pain relief and analgesit consumption
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Active comparator | Drug: Dexmedetomidinepatients will recive dexmedetomidine i.v. infusion at 0.4 μg/kg/h |
| Group L | Active comparator | Drug: Lidocaine Hydrochloride 2%patients will received 1.5 mg/kg/h lidocaine hydrochloride 2% (400 mg/20 mL) by i.v. infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than 18 years old.
- patients with both sex
- patients who are American society of Anesthesiologists class I or II
Key exclusion criteria (5 listed)
- refusal.
- body mass index (BMI) ≥40 kg/m2.
- History of hypersensitivity to the drugs being evaluated
- Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.
- chronic use of opioids and opioid addiction
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 |
|---|---|---|
| Dexmedetomidinedexmedetomidine will be administered by i.v. infusion at 0.4 μg/kg/h | Drug | Group D |
| Lidocaine Hydrochloride 2%lidocaine hydrochloride 2% (400 mg/20 mL) 1.5 mg/kg/h by i.v. infusion. | Drug | Group L |
Primary outcome
pain score NRS score
Time frame: 24 hours
The severity of pain will be assessed postoperatively using a 10 cm NRS (0 = no pain and 10 = worst imaginable pain) at rest and coughing at 0, 2nd, 4th, 6th, 12th, 18th, and 24th hours
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 7 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and Lidocaine Hydrochloride 2% in people with Fracture Hip Surgery, run by Assiut University.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
pain score NRS score (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2025.