Spine SurgeryPhase 2TAP ALIFNCT02884440
Transverse Abdominis Plane Block for Anterior Approach Spine Surgery
A Phase 2 study testing TAP block ropivacaine and General anesthesia in people with Spine Surgery and Low Back Pain, run by Rennes University Hospital at 1 site in France.
Trial summary
Therapeutic, prospective, randomized, double blind, placebo-controlled, in intention to treat, monocentric study to evaluate the analgesic efficacy of a bilateral TAP block after spine surgery with 24 hours morphine consumption Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Surgery, Low Back Pain, Spondylolisthesis
- What is being tested?
- TAP block ropivacaine and General anesthesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 7 Nov 2016to 25 May 2019
- Phase
- Phase 2
- 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
- Patient with age above 18 years old
- Patients scheduled for spine surgery by anterior approach
- Patient who signed an informed consent form
Who cannot join
- Allergy to ropivacaine
- Weight < 50 kg
- Contra indication to TAP block : sepsis in the point of draining, bleeding disorder
- Contra indication to paracetamol: severe hepatic insufficiency
- Contra indication to ketoprofen: age ≥ 75 years, renal insufficiency, previous gastric ulcer, allergy
- Contra indication to nefopam: severe cardiac insufficiency, glaucoma, prostate hypertrophy, allergy
Show all 16Show fewer
- Known allergy to active substance or at least to one excipient (propofol, paracetamol, morphine, remifentanil, cisatracurium)
- Allergy to fentanyl, atracurium, or benzin sulfonic acid derivative, to propacetamol
- Convulsions or previous convulsive disorder
- Severe respiratory insufficiency
- Abnormal hemostasis or anticoagulant treatment because of possible intramuscular injection
- Morphine intake 24 hours before surgery
- Chronic use of morphine, gabapentin, pregabalin
- Pregnancy or breastfeeding
- Patient unable to use Patient Controlled Analgesia (PCA) (old patient depends…)
- Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transverse Abdominis Plane Block for Anterior Approach Spine Surgery: A Prospective Randomized Study
Therapeutic, prospective, randomized, double blind, placebo-controlled, in intention to treat, monocentric study to evaluate the analgesic efficacy of a bilateral TAP block after spine surgery with 24 hours morphine consumption
Read the detailed description
ALIF is a commonly performed procedure for the treatment of degenerative diseases of the lumbar spine or spondylolisthesis. This technique has many advantages attributed to the absence of posterior spinal muscular pain, a more direct visualization of the disk space, lower incidence of neurological injuries… However, patients experienced moderate to high post operative parietal abdominal pain due to this specific anterior approach. The systematic need for opioids administration may cause many complications and delay the post operative recovery time. The TAP block has been described as an effective pain control technique after various lower abdominal surgeries, reducing both pain scores and 24 hours opioids consumption. However the analgesic efficacy of this technique on specific parietal abdominal pain experienced after spine surgery by anterior approach is not clear
- Conditions
- Spine Surgery, Low Back Pain, Spondylolisthesis
- Being tested
- TAP block ropivacaine, TAP block placebo, General anesthesia
- Medical subject headings
- Low Back Pain, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP block ropivacaineDrug
TAP block placeboDrug
General anesthesiaDrug
Induction PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml CISATRACURIUM 2mg/ml if necessary DEXAMETHASONE 8 mg KETAMINE 0,15mg/kg Maintenance PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml
| Study group | Role | What they receive |
|---|---|---|
| TAP block ropivacaine | Experimental | Bilateral ultrasound guided with 15 ml ropivacaine 5mg/ml on each side under general anesthesia at the end of the intervention Receives: Drug: TAP block ropivacaine; Drug: General anesthesia |
| TAP block placebo | Placebo comparator | Bilateral ultrasound guided with 15 ml saline on each side under general anesthesia at the end of the intervention Receives: Drug: TAP block placebo; Drug: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption in the first 24 hours after spine surgery by anterior approach
Measured: 24 hours
Secondary outcomes (8)
Morphine consumption in the first 48 hours after spine surgery by anterior approach
Measured: 48 hours
Assessment of pain
Numerical Analogue score
Measured: 1, 6, 12, 24 and 48 hours
Assessment of post operative nausea or vomiting
Occurence of nausea or vomiting episodes over 48 hours
Measured: 48 hours
Delay before first morphine administration
Number of hours between end of surgery and first morphine administration
Measured: Day 1
Delay before the first lift
Number of hours between end of surgery and the first lift
Measured: Day 1
Delay before resumption of transit
Number of days between end of surgery and resumption of transit
Measured: Day 1
Duration of hospitalization
Measured: Day 1
Patient satisfaction
Satisfaction questionnaire
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start7 Nov 2016
- Primary completion25 May 2019
- Study completion25 May 2019
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 Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884440
- Sponsor's protocol ID
- 35RC15_8933_TAP-ALIF
- Acronym
- TAP ALIF
- Status last verified
- May 2023
- First submitted
- 22 Aug 2016
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Coquet A, Sion A, Bourgoin A, Ropars M, Beloeil H. Transversus abdominis plane block for anterior lumbar interbody fusion: a randomized controlled trial. Spine J. 2023 Aug;23(8):1137-1143. doi: 10.1016/j.spinee.2023.03.013. Epub 2023 Apr 7.
PubMed 37031893
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Abdominis Plane Block for Anterior Approach Spine Surgery: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02884440
- Acronym / sponsor ID
- TAP ALIF / 35RC15_8933_TAP-ALIF
- Conditions
- Spine Surgery, Low Back Pain, Spondylolisthesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 31 Aug 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.
Therapeutic, prospective, randomized, double blind, placebo-controlled, in intention to treat, monocentric study to evaluate the analgesic efficacy of a bilateral TAP block after spine surgery with 24 hours morphine consumption
Detailed description
ALIF is a commonly performed procedure for the treatment of degenerative diseases of the lumbar spine or spondylolisthesis. This technique has many advantages attributed to the absence of posterior spinal muscular pain, a more direct visualization of the disk space, lower incidence of neurological injuries… However, patients experienced moderate to high post operative parietal abdominal pain due to this specific anterior approach. The systematic need for opioids administration may cause many complications and delay the post operative recovery time. The TAP block has been described as an effective pain control technique after various lower abdominal surgeries, reducing both pain scores and 24 hours opioids consumption. However the analgesic efficacy of this technique on specific parietal abdominal pain experienced after spine surgery by anterior approach is not clear
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block ropivacaine | Experimental | Drug: TAP block ropivacaine, Drug: General anesthesiaBilateral ultrasound guided with 15 ml ropivacaine 5mg/ml on each side under general anesthesia at the end of the intervention |
| TAP block placebo | Placebo comparator | Drug: TAP block placebo, Drug: General anesthesiaBilateral ultrasound guided with 15 ml saline on each side under general anesthesia at the end of the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with age above 18 years old
- Patients scheduled for spine surgery by anterior approach
- Patient who signed an informed consent form
Key exclusion criteria (16 listed)
- Allergy to ropivacaine
- Weight < 50 kg
- Contra indication to TAP block : sepsis in the point of draining, bleeding disorder
- Contra indication to paracetamol: severe hepatic insufficiency
- Contra indication to ketoprofen: age ≥ 75 years, renal insufficiency, previous gastric ulcer, allergy
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 |
|---|---|---|
| TAP block ropivacaine | Drug | TAP block ropivacaine |
| TAP block placebo | Drug | TAP block placebo |
| General anesthesiaInduction PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml CISATRACURIUM 2mg/ml if necessary DEXAMETHASONE 8 mg KETAMINE 0,15mg/kg Maintenance PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml | Drug | TAP block placebo, TAP block ropivacaine |
Primary outcome
Morphine consumption in the first 24 hours after spine surgery by anterior approach
Time frame: 24 hours
8 secondary outcomes
Morphine consumption in the first 48 hours after spine surgery by anterior approach
Time frame: 48 hours
Assessment of pain
Time frame: 1, 6, 12, 24 and 48 hours
Assessment of post operative nausea or vomiting
Time frame: 48 hours
Delay before first morphine administration
Time frame: Day 1
Delay before the first lift
Time frame: Day 1
Delay before resumption of transit
Time frame: Day 1
Duration of hospitalization
Time frame: Day 1
Patient satisfaction
Time frame: 48 hours
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 24 May 2023.
- Results publication: PubMed 37031893Coquet A, Sion A, Bourgoin A, Ropars M, Beloeil H. Transversus abdominis plane block for anterior lumbar interbody fusion: a randomized controlled trial. Spine J. 2023 Aug;23(8):1137-1143. doi: 10.1016/j.spinee.2023.03.013. Epub 2023 Apr 7.
- Individual participant dataSharing planned: No
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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 study testing TAP block ropivacaine and General anesthesia in people with Spine Surgery and Low Back Pain, run by Rennes University Hospital 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 3 inclusion and 16 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 24 May 2023. 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 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.
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 in the first 24 hours after spine surgery by anterior approach (time frame: 24 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 NCT02884440, 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 24 May 2023.