Usage of Tramadol With Levobupivacaine for Pain Treatment... | NCT01916915

Studies
Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section

NCT01916915

Sponsor

Ufuk University

Status

Completed

Last Update Posted

Jun 29, 2016Estimated

Enrollment

65Actual

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

Tramadol infusion via wound catheter
Levobupivacaine

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Feb 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Aug 1, 2013

First Submission Date that Met QC Criteria

Aug 5, 2013

First Posted Date

Aug 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2016

Last Update Posted Date

Jun 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tramadol 1	Experimental	1 mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion	Drug: Tramadol infusion via wound catheter Drug: Levobupivacaine
Tramadol 2	Experimental	2mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion	Drug: Tramadol infusion via wound catheter Drug: Levobupivacaine
Levobupivacaine	Placebo Comparator	0.25% levobupivacaine 4ml/h infusion	Drug: Levobupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tramadol infusion via wound catheter	Drug		Tramadol 1 Tramadol 2
Levobupivacaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
lowering of pain as measured by visual analogue scores		forty eight hours after the operation

Secondary Outcomes

Measure	Description	Time Frame
total additional analgesic consumption		forty eight hours after the operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Planned cesarean section
American Society of Anesthesiologists Class I-II

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Perihan Ekmekçi, Associate Professor	Ufuk University Dr Rıdvan Ege Hospital Department of Anesthesiology and Reanimation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ufuk University Dr Rıdvan Ege Hospital		Ankara		06520	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077554	Levobupivacaine

Ancestor Terms

ID	Term
D002045	Bupivacaine
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided