Musculoskeletal PainPhase 4ILIACPCPTHRNCT02630160
The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement
A Phase 4 study testing Bupivacaine hydrochloride and Physiological Saline in people with Musculoskeletal Pain and Hip Injuries, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
A randomized double-blind clinical trial was performed. There were 4 groups according to catheter placement and infusion constituents: 1) Intraarticular catheter + anesthetics; 2) Intraarticular catheter +placebo; 3) Subfascial catheter + anesthetics; 4) Subfascial catheter + placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain, Hip Injuries
- What is being tested?
- Bupivacaine hydrochloride and Physiological Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Jun 2014
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary total Hip Replacement
Who cannot join
- Allergic to Bupivacaine
Trial locations and contacts
1 site in 1 country.
About this study
A randomized double-blind clinical trial was performed. There were 4 groups according to catheter placement and infusion constituents: 1) Intraarticular catheter + anesthetics; 2) Intraarticular catheter +placebo; 3) Subfascial catheter + anesthetics; 4) Subfascial catheter + placebo. The anesthetics infusion contained bupivacaine (bolus + continuous perfusion up to 36 hours). The placebo solution consisted in physiological serum (bolus + continuous perfusion up to 36 hours). Randomization was performed in the hospital pharmacy and the surgeon kept out the surgical field when the resident placed the catheter. The same conventional analgesic schedule was prescribed to all patients: PCA (patient controlled analgesia) + paracetamol 1g/6h + dexketoprofen 50mg/12h. The pain was evaluated by means of PCA (patient controlled analgesia) shots and the VAS (visual analog scale). Side effects, time to start rehabilitation and time to discharge were also analyzed. A statistical analysis was performed to compare all this variables between the 4 groups (SPSS 18.0).
- Conditions
- Musculoskeletal Pain, Hip Injuries
- Being tested
- Bupivacaine hydrochloride, Physiological Saline
- Medical subject headings
- Musculoskeletal Pain, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine hydrochlorideDrug
Also called Bupivacaine / epinephrine, Vivacaine
Intraarticular infusion with bupivacaine
Physiological SalineOther
Also called Flebobag Salina Fisiologica Grifols 0.9%
Intraarticular infusion physiological serum
| Study group | Role | What they receive |
|---|---|---|
| Intraarticular Catheter with anesthesic | Active comparator | Intraarticular infusion with Bupivacaine Hydrochloride Receives: Drug: Bupivacaine hydrochloride |
| Intraarticular Physiological Saline | Placebo comparator | Infusion of Physiological Saline [Flebobag Salina Fisiologica Grifols 0.9%] Sterile Solution by intraarticular catheter Receives: Other: Physiological Saline |
| Perifascial Catheter with anesthesic | Active comparator | Perifascial infusion with Bupivacaine Hydrochloride Receives: Drug: Bupivacaine hydrochloride |
| Perifascial Physiological Saline | Placebo comparator | Infusion of Physiological Saline [Flebobag Salina Fisiologica Grifols 0.9%] Sterile Solution by Perifascial catheter Receives: Other: Physiological Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain measured with a visual analog scale
Visual analog pain scale score every eight hours for 36 hours postoperatively
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startMar 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Pérez Prieto, Parc de Salut Mar
- Investigators
- Daniel Pérez Prieto, Principal investigator, Hospital del MarMarta Cuenca Llavall, Study chair, Hospital del MarFernando Marques Lopez, Study director, Hospital del MarAlfonso Leon Garcia, Study chair, Hospital del MarFrancisco Javier Santiveri Papiol, Study chair, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630160
- Sponsor's protocol ID
- 2013/5138/I
- Acronym
- ILIACPCPTHR
- Status last verified
- Dec 2015
- First submitted
- 30 Nov 2015
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement
- ClinicalTrials.gov ID
- NCT02630160
- Acronym / sponsor ID
- ILIACPCPTHR / 2013/5138/I
- Conditions
- Musculoskeletal Pain, Hip Injuries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Dec 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.
A randomized double-blind clinical trial was performed. There were 4 groups according to catheter placement and infusion constituents: 1) Intraarticular catheter + anesthetics; 2) Intraarticular catheter +placebo; 3) Subfascial catheter + anesthetics; 4) Subfascial catheter + placebo. The anesthetics infusion contained bupivacaine (bolus + continuous perfusion up to 36 hours). The placebo solution consisted in physiological serum (bolus + continuous perfusion up to 36 hours). Randomization was performed in the hospital pharmacy and the surgeon kept out the surgical field when the resident placed the catheter. The same conventional analgesic schedule was prescribed to all patients: PCA (patient controlled analgesia) + paracetamol 1g/6h + dexketoprofen 50mg/12h. The pain was evaluated by means of PCA (patient controlled analgesia) shots and the VAS (visual analog scale). Side effects, time to start rehabilitation and time to discharge were also analyzed. A statistical analysis was performed to compare all this variables between the 4 groups (SPSS 18.0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intraarticular Catheter with anesthesic | Active comparator | Drug: Bupivacaine hydrochlorideIntraarticular infusion with Bupivacaine Hydrochloride |
| Intraarticular Physiological Saline | Placebo comparator | Other: Physiological SalineInfusion of Physiological Saline [Flebobag Salina Fisiologica Grifols 0.9%] Sterile Solution by intraarticular catheter |
| Perifascial Catheter with anesthesic | Active comparator | Drug: Bupivacaine hydrochloridePerifascial infusion with Bupivacaine Hydrochloride |
| Perifascial Physiological Saline | Placebo comparator | Other: Physiological SalineInfusion of Physiological Saline [Flebobag Salina Fisiologica Grifols 0.9%] Sterile Solution by Perifascial catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary total Hip Replacement
Key exclusion criteria (1 listed)
- Allergic to Bupivacaine
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 |
|---|---|---|
| Bupivacaine hydrochlorideAlso: Bupivacaine / epinephrine, VivacaineIntraarticular infusion with bupivacaine | Drug | Intraarticular Catheter with anesthesic, Perifascial Catheter with anesthesic |
| Physiological SalineAlso: Flebobag Salina Fisiologica Grifols 0.9%Intraarticular infusion physiological serum | Other | Intraarticular Physiological Saline, Perifascial Physiological Saline |
Primary outcome
Change in pain measured with a visual analog scale
Time frame: 36 hours
Visual analog pain scale score every eight hours for 36 hours 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 12 Oct 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.
Daniel Pérez Prieto principal investigator
Hospital del Mar
Marta Cuenca Llavall study chair
Hospital del Mar
Fernando Marques Lopez study director
Hospital del Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine hydrochloride and Physiological Saline in people with Musculoskeletal Pain and Hip Injuries, run by Parc de Salut Mar at 1 site in Spain.
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 1 inclusion and 1 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 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in pain measured with a visual analog scale (time frame: 36 hours). 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 12 Oct 2016.