TAP Block Efficacy After Lumbar Spine Surgery Through Anterior Approach: a Randomized, Placebo-controlled Study
NCT ID: NCT02778178
Last Updated: 2017-05-19
Study Results
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Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2016-05-02
2017-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TAP block with ropivacaine
Bilateral single shot TAP block under ultrasound guidance: 20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side
ropivacaine plus clonidine
20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side
ultrasound
TAP block with placebo
Placebo administration: bilateral single shot TAP block under ultrasound guidance: 20 mL saline 0.9%, per side
Placebo
20 mL saline 0.9%, per side
ultrasound
Interventions
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ropivacaine plus clonidine
20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side
Placebo
20 mL saline 0.9%, per side
ultrasound
Eligibility Criteria
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Inclusion Criteria
* Patients with insurance coverage
* Patients able to provide free and informed consent
* Patients undergoing surgery by the ALIF or DLIF approaches
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Benoit Tavernier, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hôpital Roger Salengro, CHU de Lille
Lille, , France
Countries
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References
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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.
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.
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.
Raoul 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.
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.
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.
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.
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.
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.
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.
Transversus Abdominal Plane Block. 52ème congrès national d'anesthésie et de réanimation. SFAR 2010
Other Identifiers
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2015-002143-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2014-52
Identifier Type: -
Identifier Source: org_study_id
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