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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002143-34 | EudraCT Number |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| TAP block with placebo | Placebo Comparator | Placebo administration: bilateral single shot TAP block under ultrasound guidance: 20 mL saline 0.9%, per side |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaine plus clonidine | Drug | 20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption | patient-controlled administration | During the first 24 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative sufentanil consumption | infusion adjusted according to heart rate and arterial pressure | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benoit Tavernier, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Roger Salengro, CHU de Lille | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19026514 | Background | 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. | |
| 19059922 | Background |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D003000 | Clonidine |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo | Drug | 20 mL saline 0.9%, per side |
|
| ultrasound | Device |
|
| During the first 6 hours |
| Morphine consumption | patient-controlled administration | 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 | first 24 postoperative hours |
| Antiemetics consumption | During the first 24 postoperative hours |
| resumption of intestinal transit | Up to the end of hospital stay |
| visual analog scale | Measure the pain severity | 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 | At 48 hours |
| Questionnaire Douleur de Saint-Antoine (QDSA) , | evaluation with validated scores for chronic and neuropathic pains | 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 | At Baseline, At 3 and 6 months after surgery |
| Sullivan's "pain catastrophising scale", | evaluation with validated scores for chronic and neuropathic pains | 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 | At Baseline, At 3 and 6 months after surgery |
| Oswestry score | evaluation with validated scores for chronic and neuropathic pains | At Baseline, At 3 and 6 months after surgery |
| Tran 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. |
| 18428988 | Background | Rozen 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. |
| Background | Raoul S. Etude anatomique du nerf sinus vertébral. Thèse pour le Doctorat en Médecine. Faculté de Médecine de Lille (1996) |
| 19020158 | Background | 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. |
| 17179269 | Background | McDonnell 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. |
| 18165577 | Background | McDonnell 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. |
| 19700776 | Background | Belavy 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. |
| 19561014 | Background | Niraj 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. |
| 19376789 | Background | El-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. |
| 18433683 | Background | Farooq 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. |
| Background | Transversus Abdominal Plane Block. 52ème congrès national d'anesthésie et de réanimation. SFAR 2010 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |