Pain, PostoperativePhase 4TAP-LIFNCT02778178
TAP Block Efficacy After Lumbar Spine Surgery Through Anterior Approach: a Randomized, Placebo-controlled Study
A Phase 4 study testing ropivacaine plus clonidine and ultrasound in people with Pain, Postoperative, run by University Hospital, Lille at 1 site in France.
Trial summary
Anterior Lumbar Interbody Fusion (ALIF) as well as Direct Lateral Interbody Fusion (DLIF) are established techniques for lumbar interbody fusion. In contrast with posterior approaches, they allow free approach to the anterior disc space without opening of the spinal canal or the neural foramina. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ropivacaine plus clonidine and ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2016to Apr 2017
- 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
- Man or woman over the age of 18 yr
- Patients with insurance coverage
- Patients able to provide free and informed consent
- Patients undergoing surgery by the ALIF or DLIF approaches
Who cannot join
- Patients receiving opioids as chronic treatment
- Patients with contra-indication to regional anesthesia or TAP block
- Patients unable to consent
- Patient refusal
- Patients with contra-indication to any drug included in the anesthesia or analgesia protocol
- Pregnancy or breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Transversus Abdominis Plane (TAP) Block After Lumbar Spine Surgery Through Anterior Approach (Anterior Lumbar or Direct Lateral Interbody Fusion): a Prospective, Randomized, Double-blind Placebo-controlled Study
Anterior Lumbar Interbody Fusion (ALIF) as well as Direct Lateral Interbody Fusion (DLIF) are established techniques for lumbar interbody fusion. In contrast with posterior approaches, they allow free approach to the anterior disc space without opening of the spinal canal or the neural foramina. However, the additional anterior approach conveys specific concerns, including abdominal pain that may delay recovery after surgery. The transversus abdominis plane (TAP) block is a validated approach for postoperative pain relief following abdominal surgeries. There is currently no evidence of the possible benefits of TAP block as part of multimodal pain management after ALIF/DLIF surgery. The investigator hypothesize that a single-injection TAP block reduces opioid consumption after anterior lumbar fusion surgery. The main goal of this prospective, randomized, double-blind, placebo-controlled study is to demonstrate a >35% reduction in opioid consumption during the 24h following ALIF/DLIF surgery.
Read the detailed description
Clinical trial : therapeutic, prospective, randomized,double blind, placebo-controlled, with parallel group, of superiority, in intention to treat, monocentric study.
The main steps of the study are:
- preoperative assessment of eligibility
- exclusion and inclusion criteria, written informed consent, baseline preoperative assessment (see specific section)
- randomization (using a computer generated list) immediately before induction of anesthesia
- TAP block: ropivacaine + clonidine (experimental group, n=20) OR saline (control group; n=20)
- anesthesia (propofol, sufentanil, cisatracurium, ketamine and desflurane) and postoperative analgesia (paracetamol, ketoprofen, nefopam, and patient-controlled analgesia with morphine) similar in both groups
- surgical procedure
- primary outcome parameter (morphine consumption first 24 hours; see specific section)
- secondary endpoints (see specific section, up to 6 months following surgery)
- Conditions
- Pain, Postoperative
- Being tested
- ropivacaine plus clonidine, Placebo, ultrasound
- 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 plus clonidineDrug
20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side
PlaceboDrug
20 mL saline 0.9%, per side
ultrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| TAP block with ropivacaine | Experimental | Bilateral single shot TAP block under ultrasound guidance: 20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side Receives: Drug: ropivacaine plus clonidine; Device: ultrasound |
| TAP block with placebo | Placebo comparator | Placebo administration: bilateral single shot TAP block under ultrasound guidance: 20 mL saline 0.9%, per side Receives: Drug: Placebo; Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
patient-controlled administration
Measured: During the first 24 postoperative hours
Secondary outcomes (13)
intraoperative sufentanil consumption
infusion adjusted according to heart rate and arterial pressure
Measured: At the end of anesthesia
Sedation scale
using WHO Sedation scale
- 0 = awake and alert /- 1 = quietly awake / - 2 = asleep but easily roused / - 3 = deep sleep
Measured: During the first 6 hours
Morphine consumption
patient-controlled administration
Measured: between the 24 and the 48 postoperative hours
Postoperative nausea and vomiting (PONV) Score
Measure the presence and severity of postoperative nausea and vomiting the PONV score :- 1 = mild /- 2 = moderate / - 3 = severe
Measured: first 24 postoperative hours
Antiemetics consumption
Measured: During the first 24 postoperative hours
resumption of intestinal transit
Measured: Up to the end of hospital stay
visual analog scale
Measure the pain severity
Measured: At Baseline, at wake up, during the first 48 postoperative hours, At 3 and 6 months after surgery
Area peri-incisional hyperalgesia
von frey's hair
Measured: At 48 hours
Questionnaire Douleur de Saint-Antoine (QDSA) ,
evaluation with validated scores for chronic and neuropathic pains
Measured: At Baseline, At 3 and 6 months after surgery
Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),
evaluation with validated scores for chronic and neuropathic pains
Measured: At Baseline, At 3 and 6 months after surgery
Sullivan's "pain catastrophising scale",
evaluation with validated scores for chronic and neuropathic pains
Measured: At Baseline, At 3 and 6 months after surgery
Hospital Anxiety and Depression Scale (HAD scale),
evaluation with validated scores for chronic and neuropathic pains
Measured: At Baseline, At 3 and 6 months after surgery
Oswestry score
evaluation with validated scores for chronic and neuropathic pains
Measured: At Baseline, At 3 and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start2 May 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Tavernier, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778178
- Sponsor's protocol ID
- 2014-52
- Other IDs
- 2015-002143-34, 2015
- Acronym
- TAP-LIF
- Status last verified
- May 2017
- First submitted
- 18 May 2016
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Comite douleur-anesthesie locoregionale et le comite des referentiels de la Sfar. [Formalized recommendations of experts 2008. Management of postoperative pain in adults and children]. Ann Fr Anesth Reanim. 2008 Dec;27(12):1035-41. doi: 10.1016/j.annfar.2008.10.002. Epub 2008 Nov 21. No abstract available. French.
PubMed 19026514Tran TM, Ivanusic JJ, Hebbard P, Barrington MJ. Determination of spread of injectate after ultrasound-guided transversus abdominis plane block: a cadaveric study. Br J Anaesth. 2009 Jan;102(1):123-7. doi: 10.1093/bja/aen344.
PubMed 19059922Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.
PubMed 18428988Raoul S. Etude anatomique du nerf sinus vertébral. Thèse pour le Doctorat en Médecine. Faculté de Médecine de Lille (1996)
Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
PubMed 19020158McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.
PubMed 17179269McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.
PubMed 18165577Belavy D, Cowlishaw PJ, Howes M, Phillips F. Ultrasound-guided transversus abdominis plane block for analgesia after Caesarean delivery. Br J Anaesth. 2009 Nov;103(5):726-30. doi: 10.1093/bja/aep235. Epub 2009 Aug 22.
PubMed 19700776Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.
PubMed 19561014El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.
PubMed 19376789Farooq M, Carey M. A case of liver trauma with a blunt regional anesthesia needle while performing transversus abdominis plane block. Reg Anesth Pain Med. 2008 May-Jun;33(3):274-5. doi: 10.1016/j.rapm.2007.11.009. No abstract available.
PubMed 18433683Transversus Abdominal Plane Block. 52ème congrès national d'anesthésie et de réanimation. SFAR 2010
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Transversus Abdominis Plane (TAP) Block After Lumbar Spine Surgery Through Anterior Approach (Anterior Lumbar or Direct Lateral Interbody Fusion): a Prospective, Randomized, Double-blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02778178
- Acronym / sponsor ID
- TAP-LIF / 2014-52
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 2 May 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 19 May 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.
Anterior Lumbar Interbody Fusion (ALIF) as well as Direct Lateral Interbody Fusion (DLIF) are established techniques for lumbar interbody fusion. In contrast with posterior approaches, they allow free approach to the anterior disc space without opening of the spinal canal or the neural foramina. However, the additional anterior approach conveys specific concerns, including abdominal pain that may delay recovery after surgery. The transversus abdominis plane (TAP) block is a validated approach for postoperative pain relief following abdominal surgeries. There is currently no evidence of the possible benefits of TAP block as part of multimodal pain management after ALIF/DLIF surgery. The investigator hypothesize that a single-injection TAP block reduces opioid consumption after anterior lumbar fusion surgery. The main goal of this prospective, randomized, double-blind, placebo-controlled study is to demonstrate a >35% reduction in opioid consumption during the 24h following ALIF/DLIF surgery.
Detailed description
Clinical trial : therapeutic, prospective, randomized,double blind, placebo-controlled, with parallel group, of superiority, in intention to treat, monocentric study.
The main steps of the study are:
- preoperative assessment of eligibility
- exclusion and inclusion criteria, written informed consent, baseline preoperative assessment (see specific section)
- randomization (using a computer generated list) immediately before induction of anesthesia
- TAP block: ropivacaine + clonidine (experimental group, n=20) OR saline (control group; n=20)
- anesthesia (propofol, sufentanil, cisatracurium, ketamine and desflurane) and postoperative analgesia (paracetamol, ketoprofen, nefopam, and patient-controlled analgesia with morphine) similar in both groups
- surgical procedure
- primary outcome parameter (morphine consumption first 24 hours; see specific section)
- secondary endpoints (see specific section, up to 6 months following surgery)
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 |
|---|---|---|
| TAP block with ropivacaine | Experimental | Drug: ropivacaine plus clonidine, Device: ultrasoundBilateral single shot TAP block under ultrasound guidance: 20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side |
| TAP block with placebo | Placebo comparator | Drug: Placebo, Device: ultrasoundPlacebo administration: bilateral single shot TAP block under ultrasound guidance: 20 mL saline 0.9%, per side |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Man or woman over the age of 18 yr
- Patients with insurance coverage
- Patients able to provide free and informed consent
- Patients undergoing surgery by the ALIF or DLIF approaches
Key exclusion criteria (6 listed)
- Patients receiving opioids as chronic treatment
- Patients with contra-indication to regional anesthesia or TAP block
- Patients unable to consent
- Patient refusal
- Patients with contra-indication to any drug included in the anesthesia or analgesia protocol
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 plus clonidine20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side | Drug | TAP block with ropivacaine |
| Placebo20 mL saline 0.9%, per side | Drug | TAP block with placebo |
| ultrasound | Device | TAP block with placebo, TAP block with ropivacaine |
Primary outcome
Morphine consumption
Time frame: During the first 24 postoperative hours
patient-controlled administration
13 secondary outcomes
intraoperative sufentanil consumption
Time frame: At the end of anesthesia
Sedation scale
Time frame: During the first 6 hours
Morphine consumption
Time frame: between the 24 and the 48 postoperative hours
Postoperative nausea and vomiting (PONV) Score
Time frame: first 24 postoperative hours
Antiemetics consumption
Time frame: During the first 24 postoperative hours
resumption of intestinal transit
Time frame: Up to the end of hospital stay
visual analog scale
Time frame: At Baseline, at wake up, during the first 48 postoperative hours, At 3 and 6 months after surgery
Area peri-incisional hyperalgesia
Time frame: At 48 hours
Questionnaire Douleur de Saint-Antoine (QDSA) ,
Time frame: At Baseline, At 3 and 6 months after surgery
Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),
Time frame: At Baseline, At 3 and 6 months after surgery
Sullivan's "pain catastrophising scale",
Time frame: At Baseline, At 3 and 6 months after surgery
Hospital Anxiety and Depression Scale (HAD scale),
Time frame: At Baseline, At 3 and 6 months after surgery
Oswestry score
Time frame: At Baseline, At 3 and 6 months 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 19 May 2017.
- Background: PubMed 19026514Comite douleur-anesthesie locoregionale et le comite des referentiels de la Sfar. [Formalized recommendations of experts 2008. Management of postoperative pain in adults and children]. Ann Fr Anesth Reanim. 2008 Dec;27(12):1035-41. doi: 10.1016/j.annfar.2008.10.002. Epub 2008 Nov 21. No abstract available. French.
- Background: PubMed 19059922Tran TM, Ivanusic JJ, Hebbard P, Barrington MJ. Determination of spread of injectate after ultrasound-guided transversus abdominis plane block: a cadaveric study. Br J Anaesth. 2009 Jan;102(1):123-7. doi: 10.1093/bja/aen344.
- Background: PubMed 18428988Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.
- BackgroundRaoul S. Etude anatomique du nerf sinus vertébral. Thèse pour le Doctorat en Médecine. Faculté de Médecine de Lille (1996)
- Background: PubMed 19020158Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
- Background: PubMed 17179269McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.
- Background: PubMed 18165577McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.
- Background: PubMed 19700776Belavy D, Cowlishaw PJ, Howes M, Phillips F. Ultrasound-guided transversus abdominis plane block for analgesia after Caesarean delivery. Br J Anaesth. 2009 Nov;103(5):726-30. doi: 10.1093/bja/aep235. Epub 2009 Aug 22.
- Background: PubMed 19561014Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.
- Background: PubMed 19376789El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.
- Background: PubMed 18433683Farooq M, Carey M. A case of liver trauma with a blunt regional anesthesia needle while performing transversus abdominis plane block. Reg Anesth Pain Med. 2008 May-Jun;33(3):274-5. doi: 10.1016/j.rapm.2007.11.009. No abstract available.
- BackgroundTransversus Abdominal Plane Block. 52ème congrès national d'anesthésie et de réanimation. SFAR 2010
- 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.
Benoit Tavernier, MD, PhD principal investigator
University Hospital, Lille
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 ropivacaine plus clonidine and ultrasound in people with Pain, Postoperative, run by University Hospital, Lille 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 4 inclusion and 6 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 19 May 2017. 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 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?
Morphine consumption (time frame: During the first 24 postoperative 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 NCT02778178, which also lists 12 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 19 May 2017.