NCT00801528

Brief Summary

A prospective, randomized, double blind study designed to investigate analgesic efficacy of wound infusion using diclofenac or ropivacaine following Cesarean section performed via a Pfannenstiel incision.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2008

Shorter than P25 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

April 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
Last Updated

May 4, 2010

Status Verified

December 1, 2008

Enrollment Period

8 months

First QC Date

December 2, 2008

Last Update Submit

May 2, 2010

Conditions

Cesarean Section

Keywords

ropivacainediclofenaclocal anesthetic instillation

Outcome Measures

Primary Outcomes (1)

  • 1)Pain intensity 2)"Rescue" analgesia requirements

    24 hours

Study Arms (3)

Ropivacaine

ACTIVE COMPARATOR

Continuous wound instillation of ropivacaine 0.2 % at a rate set of 10 mL/hr

Drug: Ropivacaine, Diclofenac, Water for injection

Diclofenac

ACTIVE COMPARATOR

Continuous wound instillation of diclofenac (300 mg/240 ml water for injection) at a rate set of 10 mL/hr

Drug: Ropivacaine, Diclofenac, Water for injection

Water for injection

PLACEBO COMPARATOR

Continuous wound instillation of water for injection at a rate set of 10 mL/hr

Drug: Ropivacaine, Diclofenac, Water for injection

Interventions

Ropivacaine, Diclofenac, Water for injectionDRUG

Ropivacaine 0.2 %, or diclofenac (300 mg/240 ml water for injection) or water for injection will be administered as a constant instillation rate set of 10 mL/hr for the subsequent 18 postoperative hours.

DiclofenacRopivacaineWater for injection

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing Cesarean section

You may not qualify if:

  • A history of clinically significant disease:
  • cardiovascular
  • pulmonary
  • hepatic
  • renal
  • neurologic
  • psychiatric
  • metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, 44281, Israel

Location

MeSH Terms

Interventions

RopivacaineDiclofenacWaterInjections

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylacetatesAcids, CarbocyclicCarboxylic AcidsHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 3, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 4, 2010

Record last verified: 2008-12

Locations

IL(1)