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

Musculoskeletal Pain Clinical Trial

— ILIACPCPTHR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630160
• Other study ID #: 2013/5138/I
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2015
• Last updated: October 10, 2016
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary total Hip Replacement

Exclusion Criteria:

• Allergic to Bupivacaine

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Injuries
• Musculoskeletal Pain

Intervention

Drug:
• Bupivacaine hydrochloride
Intraarticular infusion with bupivacaine

Other:
• Physiological Saline
Intraarticular infusion physiological serum

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain measured with a visual analog scale	Visual analog pain scale score every eight hours for 36 hours postoperatively	36 hours	Yes