Pain Management Following Total Hip Arthroplasty (FEMORALIA)
Primary Purpose
Postoperative Pain Intensity, Rescue Pain Requirements
Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
ropivacaine + ketorolac + adrenaline
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain Intensity focused on measuring postoperative pain, morphine, total hip arthroplasty, femoral nerve block
Eligibility Criteria
Inclusion Criteria:
- 40-80 years
- ASA I-II
- THA operation
Exclusion Criteria:
- Chronic pain requiring opiates
- Language constraints preventing completion of the study
- Contraindications to regional block
Sites / Locations
- Karolinskasjukhuset
- University Hospital
- Örebro University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LIA
Femoral nerve block
Arm Description
Local infiltration analgesia using a combination of ropivacaine 300 mg + ketorolac 30 mg + adrenaline 0.5 mg
Ultrasound guided 3-in-1 block using 30 ml of 0.75% ropivacaine
Outcomes
Primary Outcome Measures
Pain intensity
Pain intensity during movement at 24 h after end of surgery
Secondary Outcome Measures
Rescue analgesic consumption
Amount of PCA morphine used for pain management
Chronic pain
Pain at 3 and 6 months after surgery using Brief Pain Inventory
Inflammation
Pre- and post-operative cytokine concentration would be measured
Full Information
NCT ID
NCT02568995
First Posted
October 2, 2015
Last Updated
September 25, 2016
Sponsor
Örebro University, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT02568995
Brief Title
Pain Management Following Total Hip Arthroplasty
Acronym
FEMORALIA
Official Title
Postoperative Pain Management Following Total Hip Arthroplasty. A Comparison Between Local Infiltration Analgesia and Ultrasound Guided 3-in-1 Block
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro University, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Total hip arthroplasty (THA) is a common and standardized procedure. Postoperative mortality after hip joint replacement is low but some complications remain, including chronic post-surgical pain (1), hip dislocation (2), infection (3), and deep vein thrombosis (4). Strategies that have been identified to reduce morbidity and mortality include: posterior surgical approach, mechanical and pharmacological prophylaxis of deep vein thrombosis, and the use of spinal anesthesia (5). One of the important factors for patient satisfaction with lower limb arthroplasty is good postoperative pain management (6). Poorly managed postoperative pain can lead to chronic post-surgical pain and therefore aggressive postoperative pain management is important (7). Several different methods have been used to treat postoperative pain following THA. Recently, local infiltration analgesia (LIA) using a combination of large volume local anesthetics (LA) and non-steroidal anti-inflammatory agents (NSAID) injected systematically peri-articularly has been used for pain management with variable success (8). We found that better analgesia could be achieved when using LIA compared to intrathecal morphine during the first few days postoperatively (9,10).
Ultrasound techniques are commonly used for peripheral nerve blocks and have been shown to reduce pain intensity and may be considered by many to be a standard of care. Specifically, the 3-in-1 block has been commonly used because of its ease of application and good pain management following total hip arthroplasty. The present study aims to compare postoperative pain intensity following local infiltration analgesia with a standardised 3-in-1 block for total hip arthroplasty.
Detailed Description
Sixty ASA I-II patients undergoing THA would be randomised to one of two groups in a double-blind study:
Group LIA: A total of 151.5 ml of a combination of 0.2% ropivacaine (150 ml), 30 mg ketorolac (1 ml) and 0.5 mg (0.5 ml) adrenaline was administered systematically peri-articularly during THA and 30 ml of normal saline for ultrasound-guided 3-in-1 block Group Femoral block: Received 30 ml of ropivacaine 0,75% for ultrasound-guided 3-in-1 block and a total of 151.5 ml of normal saline peri-articularly.
All patients would receive spinal anaesthesia with 0.5% heavy bupivacaine for surgery
Postoperatively, the following parameters would be measured:
Pain intensity at fixed time intervals during 0-7 days and thereafter at weekly intervals for 1 month
Rescue morphine consumption during 0-4, 4-24 and 24-48 h
Side effects and complications
Home readiness and length of hospital stay
Chronic pain intensity measured after 3 and 6 months using the Brief Pain Inventory
Plasma Cytokine concentration at fixed intervals
Motor block using Bromage scale
EQ5D and HOOS questionnaires
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Intensity, Rescue Pain Requirements
Keywords
postoperative pain, morphine, total hip arthroplasty, femoral nerve block
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LIA
Arm Type
Experimental
Arm Description
Local infiltration analgesia using a combination of ropivacaine 300 mg + ketorolac 30 mg + adrenaline 0.5 mg
Arm Title
Femoral nerve block
Arm Type
Active Comparator
Arm Description
Ultrasound guided 3-in-1 block using 30 ml of 0.75% ropivacaine
Intervention Type
Drug
Intervention Name(s)
ropivacaine + ketorolac + adrenaline
Intervention Description
A combination of drugs injected locally for postoperative pain management
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity during movement at 24 h after end of surgery
Time Frame
24 h
Secondary Outcome Measure Information:
Title
Rescue analgesic consumption
Description
Amount of PCA morphine used for pain management
Time Frame
0-24 h
Title
Chronic pain
Description
Pain at 3 and 6 months after surgery using Brief Pain Inventory
Time Frame
3-6 months
Title
Inflammation
Description
Pre- and post-operative cytokine concentration would be measured
Time Frame
Preoperative to 3-5 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
40-80 years
ASA I-II
THA operation
Exclusion Criteria:
Chronic pain requiring opiates
Language constraints preventing completion of the study
Contraindications to regional block
Facility Information:
Facility Name
Karolinskasjukhuset
City
Solna
Country
Sweden
Facility Name
University Hospital
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Örebro University Hospital
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Pain Management Following Total Hip Arthroplasty
We'll reach out to this number within 24 hrs