PainPhase 3NCT02728310
Local Continuous Wound Infusion of Anesthetics in the Management of Post-operative Pain After Total Hip Arthroplasty.
A Phase 3 study testing Levobupivacaine and Saline in people with Pain, run by San Salvatore Hospital of L'Aquila.
Trial summary
The combination of subarachnoid anaesthesia (SAB) and continuous local wound infiltration (LCWI) with a consistent amount of local anaesthetics could prevent central sensitization through an additive or synergistic effect because it can maintain continuous inhibition of nociceptive afferents Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Levobupivacaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Nov 2014
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-90 years of age
- American Society of Anaesthesiologists (ASA) physical status I-III
- total hip arthroplasty.
Who cannot join
- pregnancy
- body mass index (BMI) >35
- allergy to local anaesthetics
- skeletal and/or muscle abnormalities of the spine
- primary and/or secondary neurological diseases
- psychiatric diseases
Show all 12Show fewer
- history of chronic pain and/or neuropathic disorders
- history of drug abuse
- state of sepsis
- infection and/or tumours within the skin on the back
- primary or secondary coagulopathies
- primary or secondary heart, liver and renal failure.
About this study
Official title: Local Continuous Wound Infusion and Local Infusion of Anaesthetics in the Management of Post-operative Pain and Rehabilitation After Total Hip Arthroplasty: a Double-blind Randomized Controlled Clinical Trial
The combination of subarachnoid anaesthesia (SAB) and continuous local wound infiltration (LCWI) with a consistent amount of local anaesthetics could prevent central sensitization through an additive or synergistic effect because it can maintain continuous inhibition of nociceptive afferents
Read the detailed description
Wound infiltration with local anesthetics is an analgesic technique that has been adopted for post-operative analgesia following a range of surgical orthopaedic procedures. Pain management by infusion of local aesthetic into wounds was found to improve pain, reduced opioid use and side effects, increase patient satisfaction, and shorten the hospital stay when compared to placebo or no treatment, but actually it was not definitively proven that wound infiltration provides additional analgesic or outcome benefit in the setting of a comprehensive multimodal analgesic approach. The hypothesis of this study is that a consistent amount of Levobupivacaine 0.5% for LCWI and LIA could provide a more extended postoperative analgesia for post-operative incident and rest pain with a better post-operative recovery and rehabilitation following THA, in the first 72 hours after surgery.
- Conditions
- Pain
- Being tested
- Levobupivacaine, Saline
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Chiracaine
An infusion rate of 10 ml/h of 1500 mg of 0.5 % of levobupivacaine for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected into the surgical wound.
SalineDrug
Also called Saline solution
An infusion rate of 10 ml/h of 300 ml of saline solution for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected into the surgical wound.
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine infusion | Active comparator | 1500 mg of Levobupivacaine by an infusion rate of 10 ml/h for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected. Receives: Drug: Levobupivacaine |
| Saline infusion | Placebo comparator | 300 ml of Saline (for Levobupivacaine as placebo) by an infusion rate of 10 ml/h for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident and rest pain (using VAS score) at 72 hours after surgery
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 72 hours
Secondary outcomes (5)
Consumption of painkillers (in mg) at 72 hours after surgery
The equianalgesic dose (in mg) of morphine
Measured: 72 hours
Side effects (PONV) at 72 hours after surgery
Time to have post-operative nausea and vomiting (in minutes)
Measured: 72 hours
Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery
Presence or not of epilepsy
Measured: 72 hours
Wound healing at 72 hours
Number of infections of surgical wound.
Measured: 72 hours
Improvement of rehabilitation at 72 hours
Our total hip arthroplasy rehabilitation protocol is focused on the following manoeuvres: contraction of the gluteal and quadricipital muscles, passive and active mobilization of the hip joint, passive and active mobilization of the knee and walking with crutches and a walker.the improvement of rehabilitation manoeuvres has been evaluated in a four-step scale: 0-no improvement; 1- slight improvement, 2- good improvement; 3- great improvement.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionNov 2014
Why it stopped: Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Salvatore Hospital of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emiliano Petrucci, San Salvatore Hospital of L'Aquila
- Investigators
- Pierfrancesco Fusco, MD, Principal investigator, Anesthesia and Intensive care Unit, San Salvatore Academic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728310
- Sponsor's protocol ID
- 0080580/12
- Status last verified
- Aug 2020
- First submitted
- 15 Mar 2016
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Konopka JF, Hansen VJ, Rubash HE, Freiberg AA. Risk assessment tools used to predict outcomes of total hip and total knee arthroplasty. Orthop Clin North Am. 2015 Jul;46(3):351-62, ix-x. doi: 10.1016/j.ocl.2015.02.004. Epub 2015 Mar 24.
PubMed 26043049Di Puccio F, Mattei L. Biotribology of artificial hip joints. World J Orthop. 2015 Jan 18;6(1):77-94. doi: 10.5312/wjo.v6.i1.77. eCollection 2015 Jan 18.
PubMed 25621213
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Continuous Wound Infusion and Local Infusion of Anaesthetics in the Management of Post-operative Pain and Rehabilitation After Total Hip Arthroplasty: a Double-blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02728310
- Acronym / sponsor ID
- 0080580/12
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated
- Enrolment
- 96 participants (actual)
- Lead sponsor
- San Salvatore Hospital of L'AquilaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 Apr 2016 (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.
The combination of subarachnoid anaesthesia (SAB) and continuous local wound infiltration (LCWI) with a consistent amount of local anaesthetics could prevent central sensitization through an additive or synergistic effect because it can maintain continuous inhibition of nociceptive afferents
Detailed description
Wound infiltration with local anesthetics is an analgesic technique that has been adopted for post-operative analgesia following a range of surgical orthopaedic procedures. Pain management by infusion of local aesthetic into wounds was found to improve pain, reduced opioid use and side effects, increase patient satisfaction, and shorten the hospital stay when compared to placebo or no treatment, but actually it was not definitively proven that wound infiltration provides additional analgesic or outcome benefit in the setting of a comprehensive multimodal analgesic approach. The hypothesis of this study is that a consistent amount of Levobupivacaine 0.5% for LCWI and LIA could provide a more extended postoperative analgesia for post-operative incident and rest pain with a better post-operative recovery and rehabilitation following THA, in the first 72 hours after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine infusion | Active comparator | Drug: Levobupivacaine1500 mg of Levobupivacaine by an infusion rate of 10 ml/h for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected. |
| Saline infusion | Placebo comparator | Drug: Saline300 ml of Saline (for Levobupivacaine as placebo) by an infusion rate of 10 ml/h for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-90 years of age
- American Society of Anaesthesiologists (ASA) physical status I-III
- total hip arthroplasty.
Key exclusion criteria (12 listed)
- pregnancy
- body mass index (BMI) >35
- allergy to local anaesthetics
- skeletal and/or muscle abnormalities of the spine
- primary and/or secondary neurological diseases
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 |
|---|---|---|
| LevobupivacaineAlso: ChiracaineAn infusion rate of 10 ml/h of 1500 mg of 0.5 % of levobupivacaine for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected into the surgical wound. | Drug | Levobupivacaine infusion |
| SalineAlso: Saline solutionAn infusion rate of 10 ml/h of 300 ml of saline solution for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected into the surgical wound. | Drug | Saline infusion |
Primary outcome
Incident and rest pain (using VAS score) at 72 hours after surgery
Time frame: 72 hours
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
5 secondary outcomes
Consumption of painkillers (in mg) at 72 hours after surgery
Time frame: 72 hours
Side effects (PONV) at 72 hours after surgery
Time frame: 72 hours
Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery
Time frame: 72 hours
Wound healing at 72 hours
Time frame: 72 hours
Improvement of rehabilitation at 72 hours
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Background: PubMed 26043049Konopka JF, Hansen VJ, Rubash HE, Freiberg AA. Risk assessment tools used to predict outcomes of total hip and total knee arthroplasty. Orthop Clin North Am. 2015 Jul;46(3):351-62, ix-x. doi: 10.1016/j.ocl.2015.02.004. Epub 2015 Mar 24.
- Results publication: PubMed 25621213Di Puccio F, Mattei L. Biotribology of artificial hip joints. World J Orthop. 2015 Jan 18;6(1):77-94. doi: 10.5312/wjo.v6.i1.77. eCollection 2015 Jan 18.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Pierfrancesco Fusco, MD principal investigator
Anesthesia and Intensive care Unit, San Salvatore Academic Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levobupivacaine and Saline in people with Pain, run by San Salvatore Hospital of L'Aquila.
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 12 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: stopped early, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Terminated). Results are not available in the source record.
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?
Incident and rest pain (using VAS score) at 72 hours after surgery (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02728310, which also lists 2 linked publications.
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 12 Aug 2020.