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Clinical Trials/NCT02630160
NCT02630160
Completed
Phase 4

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

Parc de Salut Mar1 site in 1 country100 target enrollmentMarch 2013

Overview

Phase
Phase 4
Intervention
Bupivacaine hydrochloride
Conditions
Musculoskeletal Pain
Sponsor
Parc de Salut Mar
Enrollment
100
Locations
1
Primary Endpoint
Change in pain measured with a visual analog scale
Status
Completed
Last Updated
9 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
June 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Parc de Salut Mar
Responsible Party
Principal Investigator
Principal Investigator

Daniel Pérez Prieto

MD

Parc de Salut Mar

Eligibility Criteria

Inclusion Criteria

  • Primary total Hip Replacement

Exclusion Criteria

  • Allergic to Bupivacaine

Arms & Interventions

Intraarticular Catheter with anesthesic

Intraarticular infusion with Bupivacaine Hydrochloride

Intervention: Bupivacaine hydrochloride

Intraarticular Physiological Saline

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

Intervention: Physiological Saline

Perifascial Catheter with anesthesic

Perifascial infusion with Bupivacaine Hydrochloride

Intervention: Bupivacaine hydrochloride

Perifascial Physiological Saline

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

Intervention: Physiological Saline

Outcomes

Primary Outcomes

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

Study Sites (1)

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