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The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement

NCT ID: NCT02630160

Last Updated: 2016-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-06-30

Brief Summary

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A randomized double-blind clinical trial was performed. There were 4 groups according to catheter placement and infusion constituents: 1) Intraarticular catheter + anesthetics; 2) Intraarticular catheter +placebo; 3) Subfascial catheter + anesthetics; 4) Subfascial catheter + placebo. The anesthetics infusion contained bupivacaine (bolus + continuous perfusion up to 36 hours). The placebo solution consisted in physiological serum (bolus + continuous perfusion up to 36 hours). Randomization was performed in the hospital pharmacy and the surgeon kept out the surgical field when the resident placed the catheter. The same conventional analgesic schedule was prescribed to all patients: PCA (patient controlled analgesia) + paracetamol 1g/6h + dexketoprofen 50mg/12h. The pain was evaluated by means of PCA (patient controlled analgesia) shots and the VAS (visual analog scale). Side effects, time to start rehabilitation and time to discharge were also analyzed. A statistical analysis was performed to compare all this variables between the 4 groups (SPSS 18.0).

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Detailed Description

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Conditions

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Musculoskeletal Pain Hip Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intraarticular Catheter with anesthesic

Intraarticular infusion with Bupivacaine Hydrochloride

Group Type ACTIVE_COMPARATOR

Bupivacaine hydrochloride

Intervention Type DRUG

Intraarticular infusion with bupivacaine

Intraarticular Physiological Saline

Infusion of Physiological Saline \[Flebobag Salina Fisiologica Grifols 0.9%\] Sterile Solution by intraarticular catheter

Group Type PLACEBO_COMPARATOR

Physiological Saline

Intervention Type OTHER

Intraarticular infusion physiological serum

Perifascial Catheter with anesthesic

Perifascial infusion with Bupivacaine Hydrochloride

Group Type ACTIVE_COMPARATOR

Bupivacaine hydrochloride

Intervention Type DRUG

Intraarticular infusion with bupivacaine

Perifascial Physiological Saline

Infusion of Physiological Saline \[Flebobag Salina Fisiologica Grifols 0.9%\] Sterile Solution by Perifascial catheter

Group Type PLACEBO_COMPARATOR

Physiological Saline

Intervention Type OTHER

Intraarticular infusion physiological serum

Interventions

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Bupivacaine hydrochloride

Intraarticular infusion with bupivacaine

Intervention Type DRUG

Physiological Saline

Intraarticular infusion physiological serum

Intervention Type OTHER

Other Intervention Names

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Bupivacaine / epinephrine, Vivacaine Flebobag Salina Fisiologica Grifols 0.9%

Eligibility Criteria

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Inclusion Criteria

* Primary total Hip Replacement

Exclusion Criteria

* Allergic to Bupivacaine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Daniel Pérez Prieto

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Pérez Prieto

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar

Marta Cuenca Llavall

Role: STUDY_CHAIR

Hospital del Mar

Fernando Marques Lopez

Role: STUDY_DIRECTOR

Hospital del Mar

Alfonso Leon Garcia

Role: STUDY_CHAIR

Hospital del Mar

Francisco Javier Santiveri Papiol

Role: STUDY_CHAIR

Hospital del Mar

Locations

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Hospital del Mar

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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2013/5138/I

Identifier Type: -

Identifier Source: org_study_id

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