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

October 10, 2016 updated by: Daniel Pérez Prieto, Parc de Salut Mar
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital Del Mar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary total Hip Replacement

Exclusion Criteria:

  • Allergic to Bupivacaine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intraarticular Catheter with anesthesic
Intraarticular infusion with Bupivacaine Hydrochloride
Drug: Bupivacaine hydrochloride
Intraarticular infusion with bupivacaine
Other Names:
  • Bupivacaine / epinephrine, Vivacaine
Placebo Comparator: Intraarticular Physiological Saline
Infusion of Physiological Saline [Flebobag Salina Fisiologica Grifols 0.9%] Sterile Solution by intraarticular catheter
Other: Physiological Saline
Intraarticular infusion physiological serum
Other Names:
  • Flebobag Salina Fisiologica Grifols 0.9%
Active Comparator: Perifascial Catheter with anesthesic
Perifascial infusion with Bupivacaine Hydrochloride
Drug: Bupivacaine hydrochloride
Intraarticular infusion with bupivacaine
Other Names:
  • Bupivacaine / epinephrine, Vivacaine
Placebo Comparator: Perifascial Physiological Saline
Infusion of Physiological Saline [Flebobag Salina Fisiologica Grifols 0.9%] Sterile Solution by Perifascial catheter
Other: Physiological Saline
Intraarticular infusion physiological serum
Other Names:
  • Flebobag Salina Fisiologica Grifols 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain measured with a visual analog scale
Time Frame: 36 hours
Visual analog pain scale score every eight hours for 36 hours postoperatively
36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Investigators

  • Principal Investigator: Daniel Pérez Prieto, Hospital Del Mar
  • Study Chair: Marta Cuenca Llavall, Hospital Del Mar
  • Study Director: Fernando Marques Lopez, Hospital Del Mar
  • Study Chair: Alfonso Leon Garcia, Hospital Del Mar
  • Study Chair: Francisco Javier Santiveri Papiol, Hospital Del Mar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

December 10, 2015

First Posted (Estimate)

December 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/5138/I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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