PainPhase 4NCT01929252
Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration for Total Abdominal Hysterectomy
A Phase 4 study testing Dexmedetomidine and Levobupivacaine in people with Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the analgesic efficacy of dexmedetomidine administration in wound infiltration for total abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Dexmedetomidine and Levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2011to Aug 2012
- Phase
- Phase 4
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 yo female
- scheduled for elective hysterectomy
- no known allergies to drugs
- ASA 1=2 patients
Who cannot join
- history of diabetes
- history of chronic pain treatment
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration For Total Abdominal Hysterectomy
The aim of this study was to investigate the analgesic efficacy of dexmedetomidine administration in wound infiltration for total abdominal hysterectomy.
Read the detailed description
Abdominal hysterectomy is associated with moderate to severe postoperative pain, effective analgesia after hysterectomy essential and several techniques are used such as administration of opioids, nonsteroidal anti-inflammatory drugs and wound infiltration of local anaesthetics. Different local anaesthetics can be used for the wound infiltration techniques.Ifiltration of the surgical wound with bupivacaine following outpatient provides pain relief in the postoperative period , allows the early discharge from the outpatient surgical units.There has been increased interest in administration of analgesic prior to surgical injury. Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with sedative , anxiolytic, analgesic, sympatholytic and antihypertensive effects.Dexmedetomidine has been used intravenously before initiation of anaesthesia and it has shown to provide some analgesic effect after surgery but there were some adverse hemodynamic effects. Surgical wound administration of dexmedetomidine may be useful to avoid the adverse haemodynamic effects of intravenous administration while still providing the postoperative analgesia.
- Conditions
- Pain
- Being tested
- Dexmedetomidine, Levobupivacaine
- Keywords
- dexmedetomidine, wound infiltration, postoperative analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
2mcg.kg-1 dexmedetomidine wound infiltration
LevobupivacaineDrug
Also called chirocaine
0.25% levobupivacaine (40ml) wound infiltration
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | %0.25 40 ml levobupivacaine and 2 mcg/kg dexmedetomidine administered via wound infiltration just before the incision. Receives: Drug: Dexmedetomidine; Drug: Levobupivacaine |
| Levobupivacaine | Active comparator | %0.25 40 ml levobupivacaine administered via wound infiltration prior to incision. Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic Consumption
Pethidine consumption (patient controlled analgesia procedure) was recorded
Measured: 1 day after surgery
Secondary outcomes (2)
Visual Analog Scale
Visual analog scale on rest and movement was recorded.
Measured: 1 day after surgery
Haemodynamic Changes
Arterial blood pressure, heart rate, peripheral oxygen saturation
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startAug 2011
- Primary completionAug 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ulgey, TC Erciyes University
- Investigators
- Fatih M. Kurt, Resident, Principal investigator, TC Erciyes UniversityAyse Ulgey, Asst. Prof, Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929252
- Sponsor's protocol ID
- 2011/07
- Status last verified
- Aug 2013
- First submitted
- 21 Aug 2013
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration For Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT01929252
- Acronym / sponsor ID
- 2011/07
- Conditions
- Pain
- Keywords
- dexmedetomidine, wound infiltration, postoperative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Aug 2013 (estimated)
- 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 was to investigate the analgesic efficacy of dexmedetomidine administration in wound infiltration for total abdominal hysterectomy.
Detailed description
Abdominal hysterectomy is associated with moderate to severe postoperative pain, effective analgesia after hysterectomy essential and several techniques are used such as administration of opioids, nonsteroidal anti-inflammatory drugs and wound infiltration of local anaesthetics. Different local anaesthetics can be used for the wound infiltration techniques.Ifiltration of the surgical wound with bupivacaine following outpatient provides pain relief in the postoperative period , allows the early discharge from the outpatient surgical units.There has been increased interest in administration of analgesic prior to surgical injury. Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with sedative , anxiolytic, analgesic, sympatholytic and antihypertensive effects.Dexmedetomidine has been used intravenously before initiation of anaesthesia and it has shown to provide some analgesic effect after surgery but there were some adverse hemodynamic effects. Surgical wound administration of dexmedetomidine may be useful to avoid the adverse haemodynamic effects of intravenous administration while still providing the postoperative analgesia.
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 |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine, Drug: Levobupivacaine%0.25 40 ml levobupivacaine and 2 mcg/kg dexmedetomidine administered via wound infiltration just before the incision. |
| Levobupivacaine | Active comparator | Drug: Levobupivacaine%0.25 40 ml levobupivacaine administered via wound infiltration prior to incision. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 yo female
- scheduled for elective hysterectomy
- no known allergies to drugs
- ASA 1=2 patients
Key exclusion criteria (3 listed)
- history of diabetes
- history of chronic pain treatment
- pregnancy
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 |
|---|---|---|
| DexmedetomidineAlso: precedex2mcg.kg-1 dexmedetomidine wound infiltration | Drug | Dexmedetomidine |
| LevobupivacaineAlso: chirocaine0.25% levobupivacaine (40ml) wound infiltration | Drug | Dexmedetomidine, Levobupivacaine |
Primary outcome
Analgesic Consumption
Time frame: 1 day after surgery
Pethidine consumption (patient controlled analgesia procedure) was recorded
2 secondary outcomes
Visual Analog Scale
Time frame: 1 day after surgery
Haemodynamic Changes
Time frame: During the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
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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.
Fatih M. Kurt, Resident principal investigator
TC Erciyes University
Ayse Ulgey, Asst. Prof study director
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Levobupivacaine in people with Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 27 Aug 2013. 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 Turkey (Türkiye). 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Analgesic Consumption (time frame: 1 day after surgery). 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 27 Aug 2013.