Pain, PostoperativePhase 4NCT01916915
Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section
A Phase 4 study testing Tramadol infusion via wound catheter and Levobupivacaine in people with Pain, Postoperative, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
Patients experience considerable amount of pain after cesarean section. The aim of this study is to investigate the effect of tramadol (an opioid pain killer) added to levobupivacaine (a local anesthetic) in continuous wound infusion (which is done by placing a catheter in the incision) after cesarean sections. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Tramadol infusion via wound catheter and Levobupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2013to Mar 2016
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Planned cesarean section
- American Society of Anesthesiologists Class I-II
Who cannot join
- Patients refusing to enroll in the study
- Serious coagulopathy
- Serious systemic disease
- Story of allergy to drugs being used in the study
- Morbid obesity (Body mass index > 30)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ufuk University Dr Rıdvan Ege Hospital
Ankara, 06520
About this study
Official title: The Effect of Addition of Tramadol to Levobupivacaine in Continuous Wound Infusion for Postoperative Pain Treatment in Cesarean Section
Patients experience considerable amount of pain after cesarean section. The aim of this study is to investigate the effect of tramadol (an opioid pain killer) added to levobupivacaine (a local anesthetic) in continuous wound infusion (which is done by placing a catheter in the incision) after cesarean sections.
- Conditions
- Pain, Postoperative
- Being tested
- Tramadol infusion via wound catheter, Levobupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol infusion via wound catheterDrug
LevobupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Tramadol 1 | Experimental | 1 mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion Receives: Drug: Tramadol infusion via wound catheter; Drug: Levobupivacaine |
| Tramadol 2 | Experimental | 2mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion Receives: Drug: Tramadol infusion via wound catheter; Drug: Levobupivacaine |
| Levobupivacaine | Placebo comparator | 0.25% levobupivacaine 4ml/h infusion Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
lowering of pain as measured by visual analogue scores
Measured: forty eight hours after the operation
Secondary outcomes (1)
total additional analgesic consumption
Measured: forty eight hours after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perihan Ekmekçi, Ufuk University
- Investigators
- Perihan Ekmekçi, Associate Professor, Principal investigator, Ufuk University Dr Rıdvan Ege Hospital Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916915
- Sponsor's protocol ID
- 09/06
- Status last verified
- Jun 2016
- First submitted
- 1 Aug 2013
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Addition of Tramadol to Levobupivacaine in Continuous Wound Infusion for Postoperative Pain Treatment in Cesarean Section
- ClinicalTrials.gov ID
- NCT01916915
- Acronym / sponsor ID
- 09/06
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 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.
Patients experience considerable amount of pain after cesarean section. The aim of this study is to investigate the effect of tramadol (an opioid pain killer) added to levobupivacaine (a local anesthetic) in continuous wound infusion (which is done by placing a catheter in the incision) after cesarean sections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tramadol 1 | Experimental | Drug: Tramadol infusion via wound catheter, Drug: Levobupivacaine1 mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion |
| Tramadol 2 | Experimental | Drug: Tramadol infusion via wound catheter, Drug: Levobupivacaine2mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion |
| Levobupivacaine | Placebo comparator | Drug: Levobupivacaine0.25% levobupivacaine 4ml/h infusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Planned cesarean section
- American Society of Anesthesiologists Class I-II
Key exclusion criteria (5 listed)
- Patients refusing to enroll in the study
- Serious coagulopathy
- Serious systemic disease
- Story of allergy to drugs being used in the study
- Morbid obesity (Body mass index > 30)
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 |
|---|---|---|
| Tramadol infusion via wound catheter | Drug | Tramadol 1, Tramadol 2 |
| Levobupivacaine | Drug | Levobupivacaine, Tramadol 1, Tramadol 2 |
Primary outcome
lowering of pain as measured by visual analogue scores
Time frame: forty eight hours after the operation
1 secondary outcome
total additional analgesic consumption
Time frame: forty eight hours after the operation
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 29 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Perihan Ekmekçi, Associate Professor principal investigator
Ufuk University Dr Rıdvan Ege Hospital Department of Anesthesiology and Reanimation
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 Tramadol infusion via wound catheter and Levobupivacaine in people with Pain, Postoperative, run by Ufuk 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 2 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 29 Jun 2016. 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?
lowering of pain as measured by visual analogue scores (time frame: forty eight hours after the operation). 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 29 Jun 2016.