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

Phase 4

Completed

• Conditions: Musculoskeletal Pain; Hip Injuries
• Interventions: Other: Physiological Saline; Drug: Bupivacaine hydrochloride

• Registration Number: NCT02630160
• Lead Sponsor: Parc de Salut Mar

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Study First Submitted: 2015-11-30
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-15
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Primary total Hip Replacement

Exclusion Criteria

• Allergic to Bupivacaine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraarticular Physiological Saline	Physiological Saline	Infusion of Physiological Saline \[Flebobag Salina Fisiologica Grifols 0.9%\] Sterile Solution by intraarticular catheter
Perifascial Physiological Saline	Physiological Saline	Infusion of Physiological Saline \[Flebobag Salina Fisiologica Grifols 0.9%\] Sterile Solution by Perifascial catheter
Perifascial Catheter with anesthesic	Bupivacaine hydrochloride	Perifascial infusion with Bupivacaine Hydrochloride
Intraarticular Catheter with anesthesic	Bupivacaine hydrochloride	Intraarticular infusion with Bupivacaine Hydrochloride

Primary Outcome Measures

Name	Time	Method
Change in pain measured with a visual analog scale	36 hours	Visual analog pain scale score every eight hours for 36 hours postoperatively

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain