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OpenTrials
Completed

NCT Number: NCT02630160

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital del Mar

Barcelona, 08003, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary total Hip Replacement

Exclusion criteria

  • Allergic to Bupivacaine

Treatment and study plan

Bupivacaine Hydrochloride

Drug

Intraarticular infusion with bupivacaine

Other names: Bupivacaine / epinephrine, Vivacaine

Physiological Saline

Other

Intraarticular infusion physiological serum

Other names: Flebobag Salina Fisiologica Grifols 0.9%

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Acronym: ILIACPCPTHR

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 15, 2015
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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