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Postoperative Pain Treatment in Total Hip Arthroplasty: A Study to Assess the Effect of Local Analgesia

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine, Ketorolac and Adrenalin
Placebo
Sponsored by
Vejle Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Hip Arthroplasty, Treatment Outcome, Local Anesthesia

Eligibility Criteria

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

Inclusion Criteria:

  • Scheduled for an uncemented unilateral Total Hip Replacement because of osteoarthritis
  • Willingness and possibility to follow the instructions of the study
  • 18 years or older
  • written informed consent and authority after it has been read and understood.

Exclusion Criteria:

  • Operation with anterior approach or using navigation
  • Do not understand or speech danish
  • Can not use the pain-score Numerical Rating Scale (NRS)
  • Special indications for Total Hip Replacement
  • Anaesthetized in general anaesthesia where a tube is demanded
  • Daily use of strong opioids, based on the investigators assessment
  • Fertile women
  • ASA-score: 3 and 4
  • Known allergy against the standardized pain treatment, the study drugs and placebo, Ropivacaine, Ketorolac, Adrenalin.
  • Treatment with Lithium, Dihydroergotamin, full anticoagulant treatment or MAO-inhibitor
  • Following illness:
  • Active gastric ulcer or earlier gastrointestinal bleeding, ulceration or perforation of any kind.
  • Suspicions of manifest gastrointestinal bleeding and/or cerebrovascular bleeding
  • Haemorrhagic diathesis
  • Coagulation disorder
  • Severe thrombocytopenia
  • Severe heart insufficiency
  • Severe risk of postoperative bleeding or delayed haemostatic
  • Myocardium hypertrophy or ischaemic heart disease
  • Hypertension
  • Hypovolemics
  • Anhydration
  • angiooedema
  • Asthma
  • Bronchospasm
  • Severe liver insufficiency
  • Rhinostenosis because of polyostotic
  • Narrow-angled glaucoma
  • Phaeochromocytoma
  • Low plasm-potassium
  • Thyreotoxicosis

Sites / Locations

  • Orthopaedic Department
  • Ortopaedic Department, Vejle Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

This group receive local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg 10 and 22 hours after the operation. The medicine solution is given in a catheter, wich is placed in the hip at the end of the operation.

This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, wich is placed in the hip at the end of the operation.

Outcomes

Primary Outcome Measures

Pain score
Opioid Consumption

Secondary Outcome Measures

Pain score
Opioid consumption
Postoperative Nausea and Vomiting (PONV)
Fatigue
Physical function

Full Information

First Posted
January 2, 2008
Last Updated
December 8, 2011
Sponsor
Vejle Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00603083
Brief Title
Postoperative Pain Treatment in Total Hip Arthroplasty: A Study to Assess the Effect of Local Analgesia
Official Title
Postoperative Pain Treatment in Total Hip Arthroplasty A Randomized Double-blinded Placebo-controlled Study to Assess the Effect of Local Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vejle Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether the investigator standardized pain treatment plus local pain treatment is more effective than the investigator standardized pain treatment plus placebo in total hip arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Hip Arthroplasty, Treatment Outcome, Local Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
This group receive local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg 10 and 22 hours after the operation. The medicine solution is given in a catheter, wich is placed in the hip at the end of the operation.
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, wich is placed in the hip at the end of the operation.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine, Ketorolac and Adrenalin
Other Intervention Name(s)
Naropin, Toradol
Intervention Description
The local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg is given 10 and 22 hours after the operation. The medicine solution is administrated in a catheter, which is placed in the hip at the end of the operation.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, which is placed in the hip at the end of the operation.
Primary Outcome Measure Information:
Title
Pain score
Time Frame
24 hours
Title
Opioid Consumption
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain score
Time Frame
7 days
Title
Opioid consumption
Time Frame
3 days
Title
Postoperative Nausea and Vomiting (PONV)
Time Frame
3 days
Title
Fatigue
Time Frame
3 days
Title
Physical function
Time Frame
2 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled for an uncemented unilateral Total Hip Replacement because of osteoarthritis Willingness and possibility to follow the instructions of the study 18 years or older written informed consent and authority after it has been read and understood. Exclusion Criteria: Operation with anterior approach or using navigation Do not understand or speech danish Can not use the pain-score Numerical Rating Scale (NRS) Special indications for Total Hip Replacement Anaesthetized in general anaesthesia where a tube is demanded Daily use of strong opioids, based on the investigators assessment Fertile women ASA-score: 3 and 4 Known allergy against the standardized pain treatment, the study drugs and placebo, Ropivacaine, Ketorolac, Adrenalin. Treatment with Lithium, Dihydroergotamin, full anticoagulant treatment or MAO-inhibitor Following illness: Active gastric ulcer or earlier gastrointestinal bleeding, ulceration or perforation of any kind. Suspicions of manifest gastrointestinal bleeding and/or cerebrovascular bleeding Haemorrhagic diathesis Coagulation disorder Severe thrombocytopenia Severe heart insufficiency Severe risk of postoperative bleeding or delayed haemostatic Myocardium hypertrophy or ischaemic heart disease Hypertension Hypovolemics Anhydration angiooedema Asthma Bronchospasm Severe liver insufficiency Rhinostenosis because of polyostotic Narrow-angled glaucoma Phaeochromocytoma Low plasm-potassium Thyreotoxicosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Kjaersgaard-Andersen, MD
Organizational Affiliation
Ortopaedic Department, Vejle Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic Department
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Ortopaedic Department, Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark

12. IPD Sharing Statement

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Postoperative Pain Treatment in Total Hip Arthroplasty: A Study to Assess the Effect of Local Analgesia

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