NCT02630160

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
Last Updated

October 12, 2016

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

November 30, 2015

Last Update Submit

October 10, 2016

Conditions

Musculoskeletal PainHip Injuries

Outcome Measures

Primary Outcomes (1)

  • Change in pain measured with a visual analog scale

    Visual analog pain scale score every eight hours for 36 hours postoperatively

    36 hours

Study Arms (4)

Intraarticular Catheter with anesthesic

ACTIVE COMPARATOR

Intraarticular infusion with Bupivacaine Hydrochloride

Drug: Bupivacaine hydrochloride

Intraarticular Physiological Saline

PLACEBO COMPARATOR

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

Other: Physiological Saline

Perifascial Catheter with anesthesic

ACTIVE COMPARATOR

Perifascial infusion with Bupivacaine Hydrochloride

Drug: Bupivacaine hydrochloride

Perifascial Physiological Saline

PLACEBO COMPARATOR

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

Other: Physiological Saline

Interventions

Bupivacaine hydrochlorideDRUG

Intraarticular infusion with bupivacaine

Also known as: Bupivacaine / epinephrine, Vivacaine
Intraarticular Catheter with anesthesicPerifascial Catheter with anesthesic
Physiological SalineOTHER

Intraarticular infusion physiological serum

Also known as: Flebobag Salina Fisiologica Grifols 0.9%
Intraarticular Physiological SalinePerifascial Physiological Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary total Hip Replacement

You may not qualify if:

  • Allergic to Bupivacaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Musculoskeletal PainHip Injuries

Interventions

BupivacaineEpinephrine

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Daniel Pérez Prieto

    Hospital del Mar

    PRINCIPAL INVESTIGATOR

  • Marta Cuenca Llavall

    Hospital del Mar

    STUDY CHAIR

  • Fernando Marques Lopez

    Hospital del Mar

    STUDY DIRECTOR

  • Alfonso Leon Garcia

    Hospital del Mar

    STUDY CHAIR

  • Francisco Javier Santiveri Papiol

    Hospital del Mar

    STUDY CHAIR

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
MD

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 15, 2015

Study Start

March 1, 2013

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

October 12, 2016

Record last verified: 2015-12

Locations

ES(1)