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Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty

Primary Purpose

Osteoarthritis, Hip

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

local infiltration anesthesia using Ropivacaine and Epinephrine

local infiltration anesthesia using saline

Multimodal analgesic regimen

About this trial

This is an interventional supportive care trial for Osteoarthritis, Hip focused on measuring Arthroplasty, Replacement, Hip, Anesthesia, Local, Ropivacaine, Randomized controlled trial

Eligibility Criteria

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

Inclusion Criteria:

all patients receiving total hip arthroplasty in the study period

Exclusion Criteria:

contraindications to receive spinal anesthetic, Dexamethasone or Acetaminophen.
Patients who received general anaesthetic
patients who will get a different operation than standard direct lateral surgery
Patients with osteosynthesis to be removed in the same operation

Sites / Locations

St.Olavs Hospital, Department of Orthopedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

LIA placebo

LIA Ropivacaine

Arm Description

local infiltration anesthesia using saline i addition to multimodal analgesic regimen

local infiltration anesthesia using Ropivacaine and Epinephrine i addition to multimodal analgesic regimen

Outcomes

Primary Outcome Measures

postoperative pain assessed by numeric rating scale

assessed by numeric rating scale

Secondary Outcome Measures

Full Information

NCT ID

NCT02359136

First Posted

February 4, 2015

Last Updated

March 30, 2017

Sponsor

St. Olavs Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02359136

Brief Title

Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty

Official Title

Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

March 2013 (Actual)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Background: The Local infiltration analgesic (LIA) technique has been widely used to reduce opioid requirements and improve the patient's mobilization after total hip arthroplasty (THA). However, the evidence for LIA in THA remains to be clarified. Purpose: To evaluate whether a single shot LIA in addition to a multimodal analgesic regimen reduces acute postoperative pain and opioid requirements after THA.

6. Conditions and Keywords

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

Osteoarthritis, Hip

Keywords

Arthroplasty, Replacement, Hip, Anesthesia, Local, Ropivacaine, Randomized controlled trial

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LIA placebo

Arm Type

Placebo Comparator

Arm Description

local infiltration anesthesia using saline i addition to multimodal analgesic regimen

Arm Title

LIA Ropivacaine

Arm Type

Experimental

Arm Description

local infiltration anesthesia using Ropivacaine and Epinephrine i addition to multimodal analgesic regimen

Intervention Type

Procedure

Intervention Name(s)

local infiltration anesthesia using Ropivacaine and Epinephrine

Intervention Description

150 ml Ropivacaine 2mg/ml + 0,5 ml Epinephrine 1 mg/ml: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer.

Intervention Type

Procedure

Intervention Name(s)

local infiltration anesthesia using saline

Intervention Description

150 ml 0,9% saline: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer.

Intervention Type

Procedure

Intervention Name(s)

Multimodal analgesic regimen

Intervention Description

All patients will be operated under spinal anaesthesia with 2.0-3.0 ml Bupivacaine 0.5 % plain, preferably at the L2/L3 alternatively the L3/L4 vertebral interspace. Propofol infusion will be administrated for sedation if needed. Postoperative morphine will be given as needed intravenously when needed. After transfer to a specialized hip arthroplasty unit with a well-defined and experienced program for multimodal rehabilitation, multimodal oral opioid-sparing analgesia will be given to all patients; NSAIDS and Acetaminophen will be given at regular intervals and Oxycodone as needed.

Primary Outcome Measure Information:

Title

postoperative pain assessed by numeric rating scale

Description

assessed by numeric rating scale

Time Frame

1 day (first postoperative day)

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: all patients receiving total hip arthroplasty in the study period Exclusion Criteria: contraindications to receive spinal anesthetic, Dexamethasone or Acetaminophen. Patients who received general anaesthetic patients who will get a different operation than standard direct lateral surgery Patients with osteosynthesis to be removed in the same operation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tina Strømdal Wik, md phd

Organizational Affiliation

St. Olavs Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St.Olavs Hospital, Department of Orthopedics

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

25997827

Citation

Hofstad JK, Winther SB, Rian T, Foss OA, Husby OS, Wik TS. Perioperative local infiltration anesthesia with ropivacaine has no effect on postoperative pain after total hip arthroplasty. Acta Orthop. 2015;86(6):654-8. doi: 10.3109/17453674.2015.1053775. Epub 2015 May 22.

Results Reference

result

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Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty

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