Postoperative Pain IntensityPhase 3FEMORALIANCT02568995
Pain Management Following Total Hip Arthroplasty
A Phase 3 study testing ropivacaine + ketorolac + adrenaline in people with Postoperative Pain Intensity and Rescue Pain Requirements, run by Örebro University, Sweden at 3 sites in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Postoperative Pain Intensity, Rescue Pain Requirements
- What is being tested?
- ropivacaine + ketorolac + adrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesSweden
- Study dates
- May 2014to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40-80 years
- ASA I-II
- THA operation
Who cannot join
- Chronic pain requiring opiates
- Language constraints preventing completion of the study
- Contraindications to regional block
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
University Hospital
Örebro, 701 85
Örebro University Hospital
Örebro, 70185
Karolinskasjukhuset
Solna
About this study
Official title: Postoperative Pain Management Following Total Hip Arthroplasty. A Comparison Between Local Infiltration Analgesia and Ultrasound Guided 3-in-1 Block
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.
Read the 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
- Being tested
- ropivacaine + ketorolac + adrenaline
- Keywords
- postoperative pain, morphine, total hip arthroplasty, femoral nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine + ketorolac + adrenalineDrug
A combination of drugs injected locally for postoperative pain management
| Study group | Role | What they receive |
|---|---|---|
| LIA | Experimental | Local infiltration analgesia using a combination of ropivacaine 300 mg + ketorolac 30 mg + adrenaline 0.5 mg Receives: Drug: ropivacaine + ketorolac + adrenaline |
| Femoral nerve block | Active comparator | Ultrasound guided 3-in-1 block using 30 ml of 0.75% ropivacaine Receives: Drug: ropivacaine + ketorolac + adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity during movement at 24 h after end of surgery
Measured: 24 h
Secondary outcomes (3)
Rescue analgesic consumption
Amount of PCA morphine used for pain management
Measured: 0-24 h
Chronic pain
Pain at 3 and 6 months after surgery using Brief Pain Inventory
Measured: 3-6 months
Inflammation
Pre- and post-operative cytokine concentration would be measured
Measured: Preoperative to 3-5 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startMay 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain IntensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Gupta, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568995
- Sponsor's protocol ID
- THA2014
- Acronym
- FEMORALIA
- Status last verified
- Sep 2016
- First submitted
- 2 Oct 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Management Following Total Hip Arthroplasty. A Comparison Between Local Infiltration Analgesia and Ultrasound Guided 3-in-1 Block
- ClinicalTrials.gov ID
- NCT02568995
- Acronym / sponsor ID
- FEMORALIA / THA2014
- Keywords
- postoperative pain, morphine, total hip arthroplasty, femoral nerve block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIA | Experimental | Drug: ropivacaine + ketorolac + adrenalineLocal infiltration analgesia using a combination of ropivacaine 300 mg + ketorolac 30 mg + adrenaline 0.5 mg |
| Femoral nerve block | Active comparator | Drug: ropivacaine + ketorolac + adrenalineUltrasound guided 3-in-1 block using 30 ml of 0.75% ropivacaine |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40-80 years
- ASA I-II
- THA operation
Key exclusion criteria (3 listed)
- Chronic pain requiring opiates
- Language constraints preventing completion of the study
- Contraindications to regional block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropivacaine + ketorolac + adrenalineA combination of drugs injected locally for postoperative pain management | Drug | Femoral nerve block, LIA |
Primary outcome
Pain intensity
Time frame: 24 h
Pain intensity during movement at 24 h after end of surgery
3 secondary outcomes
Rescue analgesic consumption
Time frame: 0-24 h
Chronic pain
Time frame: 3-6 months
Inflammation
Time frame: Preoperative to 3-5 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ropivacaine + ketorolac + adrenaline in people with Postoperative Pain Intensity and Rescue Pain Requirements, run by Örebro University, Sweden at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 24 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.