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CompletedNCT01916915Updated Jun 29, 2016

Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section

A Phase 4 interventional study of Tramadol infusion via wound catheter and Levobupivacaine in Pain, Postoperative, sponsored by Ufuk University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-06-29.

Sponsored by Ufuk University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

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Conditions studied

  • Pain, Postoperative

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03

In context

Pain, Postoperative

5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's enrollment of 65 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

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Lead sponsor

Ufuk University is the lead sponsor of 41 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Planned cesarean section
  • American Society of Anesthesiologists Class I-II

Exclusion criteria

Exclusion Criteria:

  • 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)
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Tramadol 1

    1 mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion

    Drug: Tramadol infusion via wound catheter · Drug: Levobupivacaine

  • Experimental
    Tramadol 2

    2mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion

    Drug: Tramadol infusion via wound catheter · Drug: Levobupivacaine

  • Placebo comparator
    Levobupivacaine

    0.25% levobupivacaine 4ml/h infusion

    Drug: Levobupivacaine

Interventions

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What researchers measure

Primary outcomes

  1. lowering of pain as measured by visual analogue scores

    Time frame: forty eight hours after the operation

Secondary outcomes

  1. total additional analgesic consumption

    Time frame: forty eight hours after the operation

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Study locations

1 site
  • Ufuk University Dr Rıdvan Ege Hospital
    Ankara, 06520, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2013, a primary completion of Feb 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2013
First posted
Aug 6, 2013
Start
Jul 2013
Primary completionActual
Feb 2016
CompletionActual
Mar 2016
Last update
Jun 29, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01916915
Lead sponsor
Ufuk University
Responsible party
Perihan Ekmekçi (Associate Professor, Ufuk University) — Principal investigator
First posted
Aug 6, 2013
Start date
Jul 2013
Primary completion
Feb 2016
Completion
Mar 2016
Last update
Jun 29, 2016

Study contacts

Perihan Ekmekçi, Associate Professor
principal investigator · Ufuk University Dr Rıdvan Ege Hospital Department of Anesthesiology and Reanimation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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