Lumbar Spine SurgeryPhase 2/3NCT01743794
Continuous Wound Infusion in Lumbar or Thoracic Surgery
A Phase 2/3 study testing Ropivacaine and Saline solution 0.9% in people with Lumbar Spine Surgery and Thoracic Spine Surgery, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spine Surgery, Thoracic Spine Surgery
- What is being tested?
- Ropivacaine and Saline solution 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Jul 2012
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults
- > 18 years
- Physical status score I, II or III (American Society of Anesthesiologists)
- lumbar or thoracic spine surgery with arthrodesis through posterior only approach
- signed informed consent
- beneficiary of social security
Who cannot join
- vulnerable persons according to law
- scoliosis surgery
- local anesthetic allergia
- contraindication to ketamine, acetaminophene, nefopam, non steroidal anti inflammatory, ropivacaine, morphine, droperidol
- long term anti platelet aggregants
- inability to comply to protocol requirements
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- psychiatric disorders or cognitive disabilities
- chronic pain or long term opioids consumption
- diabetes
- obesity (BMI > 30)
- pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital, Departement of Anesthesia and Intensive Care
Grenoble, Auvergne-Rhône-Alpes, 38000
About this study
Official title: Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study
Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. Our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery.
Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. Patients are randomised in two groups : The "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by 8 mL/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia. The investigators hypothesize that the "treated group" will consume morphine less than the "control group".
- Conditions
- Lumbar Spine Surgery, Thoracic Spine Surgery
- Being tested
- Ropivacaine, Saline solution 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion
Saline solution 0.9%Drug
wound infusion, 0.9%, bolus 10mL followed by 8 mL/h
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine 0.2%, wound infusion | Experimental | Not described Receives: Drug: Ropivacaine |
| saline solution 0.9%, wound infusion | Placebo comparator | Not described Receives: Drug: Saline solution 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
Measured: 48 hours after surgery
Secondary outcomes (9)
number of patients in need of morphine in post surgery monitoring room
Measured: 1 hour after surgery
morphine consumption in post surgery monitoring room
Measured: 1 hour post surgery
consumption of morphine
Measured: 72 hours after surgery
global self appreciation of pain management
Measured: at 72 hours
Time required for post surgery functional recovery
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Adverse effects of morphine
Measured: 72 hours after surgery
hospitalization delay
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
asked bolus divided by delivered bolus
Measured: until 72 hours after surgery
Score for pain intensity
Measured: until 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine SurgeryStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743794
- Sponsor's protocol ID
- 1008
- Status last verified
- Dec 2012
- First submitted
- 9 May 2012
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Greze J, Vighetti A, Incagnoli P, Quesada JL, Albaladejo P, Palombi O, Tonetti J, Bosson JL, Payen JF. Does continuous wound infiltration enhance baseline intravenous multimodal analgesia after posterior spinal fusion surgery? A randomized, double-blinded, placebo-controlled study. Eur Spine J. 2017 Mar;26(3):832-839. doi: 10.1007/s00586-016-4428-1. Epub 2016 Feb 10.
PubMed 26865083
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01743794
- Acronym / sponsor ID
- 1008
- Conditions
- Lumbar Spine Surgery, Thoracic Spine Surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 6 Dec 2012 (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.
Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. Our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery.
Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. Patients are randomised in two groups : The "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by 8 mL/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia. The investigators hypothesize that the "treated group" will consume morphine less than the "control group".
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 |
|---|---|---|
| ropivacaine 0.2%, wound infusion | Experimental | Drug: Ropivacaine |
| saline solution 0.9%, wound infusion | Placebo comparator | Drug: Saline solution 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults
- > 18 years
- Physical status score I, II or III (American Society of Anesthesiologists)
- lumbar or thoracic spine surgery with arthrodesis through posterior only approach
- signed informed consent
Key exclusion criteria (11 listed)
- vulnerable persons according to law
- scoliosis surgery
- local anesthetic allergia
- contraindication to ketamine, acetaminophene, nefopam, non steroidal anti inflammatory, ropivacaine, morphine, droperidol
- long term anti platelet aggregants
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 |
|---|---|---|
| Ropivacainewound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion | Drug | ropivacaine 0.2%, wound infusion |
| Saline solution 0.9%wound infusion, 0.9%, bolus 10mL followed by 8 mL/h | Drug | saline solution 0.9%, wound infusion |
Primary outcome
morphine consumption
Time frame: 48 hours after surgery
9 secondary outcomes
number of patients in need of morphine in post surgery monitoring room
Time frame: 1 hour after surgery
morphine consumption in post surgery monitoring room
Time frame: 1 hour post surgery
consumption of morphine
Time frame: 72 hours after surgery
global self appreciation of pain management
Time frame: at 72 hours
Time required for post surgery functional recovery
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Adverse effects of morphine
Time frame: 72 hours after surgery
hospitalization delay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
asked bolus divided by delivered bolus
Time frame: until 72 hours after surgery
Score for pain intensity
Time frame: until 72 hours after surgery
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 6 Dec 2012.
- Derived from this study: PubMed 26865083Greze J, Vighetti A, Incagnoli P, Quesada JL, Albaladejo P, Palombi O, Tonetti J, Bosson JL, Payen JF. Does continuous wound infiltration enhance baseline intravenous multimodal analgesia after posterior spinal fusion surgery? A randomized, double-blinded, placebo-controlled study. Eur Spine J. 2017 Mar;26(3):832-839. doi: 10.1007/s00586-016-4428-1. Epub 2016 Feb 10.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ropivacaine and Saline solution 0.9% in people with Lumbar Spine Surgery and Thoracic Spine Surgery, run by University Hospital, Grenoble at 1 site in France.
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 6 inclusion and 11 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 6 Dec 2012. 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 France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
morphine consumption (time frame: 48 hours after surgery). 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 NCT01743794, which also lists 1 linked publication.
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 6 Dec 2012.