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

Study Overview
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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).

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

Conditions
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Musculoskeletal Pain, Hip Injuries

Intervention / Treatment
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* Drug: Bupivacaine hydrochloride
* Other: Physiological Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary total Hip Replacement Exclusion Criteria: Allergic to Bupivacaine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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