PainPhase 4TAPNCT02064530
Postoperative Analgesic Effects of Dexmedetomidine for Transversus Abdominis Plane Block
A Phase 4 study testing Bupivacaine, Dexmedetomidine and serum physiologic in people with Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
the aim of this study is evaluate postoperative analgesic effects of dexmedetomidine added to bupivacaine on TAP block in patients undergoing lower abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Bupivacaine, Dexmedetomidine and serum physiologic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2014to Sep 2015
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2
- 18-65 aged
- patient undergoing lower abdominal surgery
Who cannot join
- chronic opioid consumption
- bupivacaine and dexmedetomidine allergies
- coagulopathy
- infection at the needle insertion side
- chronic liver and kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesic Effects of Dexmedetomidine Added to Bupivacaine for Transversus Abdominis Plane Block for Lower Abdominal Surgery
the aim of this study is evaluate postoperative analgesic effects of dexmedetomidine added to bupivacaine on TAP block in patients undergoing lower abdominal surgery.
Read the detailed description
TAP block is being used a method of multimodal balanced analgesia reduces postoperative pain, opioid requirement after surgery and adverse effect of opioid such as sedation, nausea vomiting and ileus. Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.
- Conditions
- Pain
- Being tested
- Bupivacaine, Dexmedetomidine, serum physiologic
- Keywords
- TAP block, dexmedetomidine, bupivacaine, 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.
BupivacaineDrug
Also called marcaine
21 ml 0.5 %bupivacaine is applied interfasially
DexmedetomidineDrug
Also called precedex
1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied interfasially
serum physiologicDrug
21 ml serum physiologic is applied interfasially
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine | Active comparator | 0,5% 20 ml bupivacaine added 0.9% 1 ml serum physiologic on TAP block Receives: Drug: Bupivacaine |
| dexmedetomidine | Active comparator | 100 mcg dexmedetomidine added to 0,5% 20 ml bupivacaine on TAP block Receives: Drug: Dexmedetomidine |
| serum phsyologic | Sham comparator | 0,9% 21 ml serum physiologic Receives: Drug: serum physiologic |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
patient controlled analgesia
Measured: postoperative 1 day
Secondary outcomes (1)
visual analog scale
Measured: postoperative 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionSep 2015
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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Recep Aksu, TC Erciyes University
- Investigators
- Recep Aksu, assoc. prof., Study director, Erciyes universty medicine facultyGülçin Patmano, resident, Principal investigator, Erciyes universty medicine faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064530
- Sponsor's protocol ID
- 2014/37
- Acronym
- TAP
- Status last verified
- Sep 2015
- First submitted
- 14 Feb 2014
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Effects of Dexmedetomidine Added to Bupivacaine for Transversus Abdominis Plane Block for Lower Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02064530
- Acronym / sponsor ID
- TAP / 2014/37
- Conditions
- Pain
- Keywords
- TAP block, dexmedetomidine, bupivacaine, postoperative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Feb 2014 (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 is evaluate postoperative analgesic effects of dexmedetomidine added to bupivacaine on TAP block in patients undergoing lower abdominal surgery.
Detailed description
TAP block is being used a method of multimodal balanced analgesia reduces postoperative pain, opioid requirement after surgery and adverse effect of opioid such as sedation, nausea vomiting and ileus. Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bupivacaine | Active comparator | Drug: Bupivacaine0,5% 20 ml bupivacaine added 0.9% 1 ml serum physiologic on TAP block |
| dexmedetomidine | Active comparator | Drug: Dexmedetomidine100 mcg dexmedetomidine added to 0,5% 20 ml bupivacaine on TAP block |
| serum phsyologic | Sham comparator | Drug: serum physiologic0,9% 21 ml serum physiologic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1-2
- 18-65 aged
- patient undergoing lower abdominal surgery
Key exclusion criteria (5 listed)
- chronic opioid consumption
- bupivacaine and dexmedetomidine allergies
- coagulopathy
- infection at the needle insertion side
- chronic liver and kidney disease
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 |
|---|---|---|
| BupivacaineAlso: marcaine21 ml 0.5 %bupivacaine is applied interfasially | Drug | bupivacaine |
| DexmedetomidineAlso: precedex1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied interfasially | Drug | dexmedetomidine |
| serum physiologic21 ml serum physiologic is applied interfasially | Drug | serum phsyologic |
Primary outcome
opioid consumption
Time frame: postoperative 1 day
patient controlled analgesia
1 secondary outcome
visual analog scale
Time frame: postoperative 1 day
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 14 Sep 2015.
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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.
Recep Aksu, assoc. prof. study director
Erciyes universty medicine faculty
Gülçin Patmano, resident principal investigator
Erciyes universty medicine faculty
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 Bupivacaine, Dexmedetomidine and serum physiologic 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 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: finished, as of the sponsor's last update on 14 Sep 2015. 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. Some participants in this study may receive a placebo. 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?
opioid consumption (time frame: postoperative 1 day). 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 14 Sep 2015; AzTrials last refreshed its copy on 7 Nov 2026.