Back to results

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

Primary Purpose

Musculoskeletal Pain, Hip Injuries

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Bupivacaine hydrochloride

Physiological Saline

About this trial

This is an interventional treatment trial for Musculoskeletal Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Primary total Hip Replacement

Exclusion Criteria:

Allergic to Bupivacaine

Sites / Locations

Hospital del Mar

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Intraarticular Catheter with anesthesic

Intraarticular Physiological Saline

Perifascial Catheter with anesthesic

Perifascial Physiological Saline

Arm Description

Intraarticular infusion with Bupivacaine Hydrochloride

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

Perifascial infusion with Bupivacaine Hydrochloride

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

Outcomes

Primary Outcome Measures

Change in pain measured with a visual analog scale

Visual analog pain scale score every eight hours for 36 hours postoperatively

Secondary Outcome Measures

Full Information

NCT ID

NCT02630160

First Posted

November 30, 2015

Last Updated

October 10, 2016

Sponsor

Parc de Salut Mar

1. Study Identification

Unique Protocol Identification Number

NCT02630160

Brief Title

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

Acronym

ILIACPCPTHR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Parc de Salut Mar

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Musculoskeletal Pain, Hip Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intraarticular Catheter with anesthesic

Arm Type

Active Comparator

Arm Description

Intraarticular infusion with Bupivacaine Hydrochloride

Arm Title

Intraarticular Physiological Saline

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Perifascial Catheter with anesthesic

Arm Type

Active Comparator

Arm Description

Perifascial infusion with Bupivacaine Hydrochloride

Arm Title

Perifascial Physiological Saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bupivacaine hydrochloride

Other Intervention Name(s)

Bupivacaine / epinephrine, Vivacaine

Intervention Description

Intraarticular infusion with bupivacaine

Intervention Type

Other

Intervention Name(s)

Physiological Saline

Other Intervention Name(s)

Flebobag Salina Fisiologica Grifols 0.9%

Intervention Description

Intraarticular infusion physiological serum

Primary Outcome Measure Information:

Title

Change in pain measured with a visual analog scale

Description

Visual analog pain scale score every eight hours for 36 hours postoperatively

Time Frame

36 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: