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A randomized prospective trial to assess whether the use of loco regional anesthesia as adjuvant analgesic therapy is more effective of intravenous analgesia only.
A prospective randomized trial comparing intravenous analgesia alone and in association with loco regional anesthesia consisting in a homolateral Serratus Plan Block (SPB). Loco regional blockade of the serratus is further examined by allocating the patients to two different approaches: the block being performed under US guidance by the Anesthesiologist before the beginning of the procedure, or under direct visualization, by the operating surgeon, before entering the pleural cavity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serratus Plane Loco-regional block | Experimental |
plus Ropivacaine (30 ml, 0.3%), for Serratus Plane Block |
|
| Standard of Care | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine for Serratus Plane Block (SPB) | Drug | Serratus Plane Block (SPB) injection of low concentration Ropivacaine (30 ml, 0.3%), in the plane between the External Intercostal Muscle and the Serratus Anterior Muscle. |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative pain perception | Direct request to the patient to define the pain feeling, according to a Numerical Rating Scale (NRS, 0 to 10). | 24 hours from the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to perform post operative rehab exercises | Number of forced inspiratory maneuvers during rehab respiratory exercises | Measured at 24 hrs and 48 hrs after surgery |
| Systemic rescue analgesia consumption (doses) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SacroCuoreDonCalabria Research Hospital | Negrar | Verona | 37024 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23923989 | Background | Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7. | |
| 25913824 | Result | Falcoz PE, Puyraveau M, Thomas PA, Decaluwe H, Hurtgen M, Petersen RH, Hansen H, Brunelli A; ESTS Database Committee and ESTS Minimally Invasive Interest Group. Video-assisted thoracoscopic surgery versus open lobectomy for primary non-small-cell lung cancer: a propensity-matched analysis of outcome from the European Society of Thoracic Surgeon database. Eur J Cardiothorac Surg. 2016 Feb;49(2):602-9. doi: 10.1093/ejcts/ezv154. Epub 2015 Apr 26. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D008175 | Lung Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Eligible patients will be randomized between two groups:
Systemic analgesic therapy only (Endovenous/ Oral)
Systemic analgesic therapy plus loco regional therapy administered under Us. guidance before the procedure (Serratus Plane Block).
Allocation to one treatment group or another will be randomized with the aim of create two unbiased groups formed out of the same group of patients. Randomization will be provided by a software. Group allocation and treatment is overt to the investigators, but not to the patient.
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Given the trial Design, it would be impossible to blind the caregiver about the type of treatment.
Serratus Plan Block will be performed after the induction of General Anesthesia, the patients will thus be unaware wether being assigned to the Experimental or Control Arm.
Clarification (May 28, 2018):
Since their reports are directly elicited in Clinical Report Forms, they are considered outcome assessors.
Both Nurses and Physiotherapists are unaware of treatment allocation.
Number of extra doses of pain killers directly required by the patient (Morphine (0.1 mg/kg), Tramadol 100 mg or Ketorolac 30 mg)
| measured at 6 hrs, 12 hrs, 24 hrs, 36 hrs and 48hrs after surgery |
| 27160473 | Result | Bendixen M, Jorgensen OD, Kronborg C, Andersen C, Licht PB. Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial. Lancet Oncol. 2016 Jun;17(6):836-844. doi: 10.1016/S1470-2045(16)00173-X. Epub 2016 May 6. |
| 24288340 | Result | Steinthorsdottir KJ, Wildgaard L, Hansen HJ, Petersen RH, Wildgaard K. Regional analgesia for video-assisted thoracic surgery: a systematic review. Eur J Cardiothorac Surg. 2014 Jun;45(6):959-66. doi: 10.1093/ejcts/ezt525. Epub 2013 Nov 27. |
| 26449303 | Result | Broseta AM, Errando C, De Andres J, Diaz-Cambronero O, Ortega-Monzo J. Serratus plane block: the regional analgesia technique for thoracoscopy? Anaesthesia. 2015 Nov;70(11):1329-30. doi: 10.1111/anae.13263. No abstract available. |
| 31808538 | Derived | Viti A, Bertoglio P, Zamperini M, Tubaro A, Menestrina N, Bonadiman S, Avesani R, Guerriero M, Terzi A. Serratus plane block for video-assisted thoracoscopic surgery major lung resection: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2020 Mar 1;30(3):366-372. doi: 10.1093/icvts/ivz289. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |