NCT01916915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

2.6 years

First QC Date

August 1, 2013

Last Update Submit

June 28, 2016

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • lowering of pain as measured by visual analogue scores

    forty eight hours after the operation

Secondary Outcomes (1)

  • total additional analgesic consumption

    forty eight hours after the operation

Study Arms (3)

Tramadol 1

EXPERIMENTAL

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

Drug: Tramadol infusion via wound catheterDrug: Levobupivacaine

Tramadol 2

EXPERIMENTAL

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

Drug: Tramadol infusion via wound catheterDrug: Levobupivacaine

Levobupivacaine

PLACEBO COMPARATOR

0.25% levobupivacaine 4ml/h infusion

Drug: Levobupivacaine

Interventions

Tramadol infusion via wound catheterDRUG
Tramadol 1Tramadol 2
LevobupivacaineDRUG
LevobupivacaineTramadol 1Tramadol 2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University Dr Rıdvan Ege Hospital

Ankara, 06520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Perihan Ekmekçi, Associate Professor

    Ufuk University Dr Rıdvan Ege Hospital Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 1, 2013

First Posted

August 6, 2013

Study Start

July 1, 2013

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

June 29, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)